Proven design.

Time-tested
technology.
Avalus™ Bioprosthesis
Avalus™ Bioprosthesis.
Designed for life.
Table of contents

The Avalus™ valve

Relevant clinical studies

PERIGON Trial

Surgical valve therapies portfolio

Appendix
 The Avalus™ valve
History of aortic pericardial valves
Medtronic heart valve design
Design features
Durability and performance
Valve design fatigue testing
Hemodynamic performance
Optimized leaflet design
AOA™ anti-calcification tissue treatment†
AOA versus Resilia
Product specifications

Deformation- Flexible Low Pliable Interior- AOA-tissue Laser-cut

resistant base stent posts profile sewing cuff mounted treatment leaflets
leaflets

No clinical data is available that evaluates the long-term impact of AOA treatment in patients.
†
AVALUS™ VALVE

History of aortic pericardial valves

1970s 1980s 1990s 2000s 2010s

Avalus

Ionescu and Ionescu-Shiley™*

Hancock™ Pericardial 

Carpentier-Edwards Perimount™* Family

Mitroflow™* Model 11

Mitroflow™* Model 12
Mitroflow™*
MRT

Bioflo™*

Pericarbon™*

Trifecta™*

Soprano™*

Externally mounted tissue Internally mounted tissue

AVALUS™ VALVE

Medtronic heart valve design

User needs:
• Durability
• Hemodynamics
• Ease of implant
Valve Frame/stent
design design
Design inputs:
• Maximize forward flow
• Minimize leakage
• Minimize stresses
AVALUS™ VALVE

Design features

• Supra-annular design • F
 lexible sewing cuff
— Low gradients, large EOAs facilitates needle
penetration, suture
• Two-part PEEK polymer
placement, and valve
stent provides strength seating
and flexibility
• L
 ow-profile access and
• Interior-mounted
visibility during implant
design — a platform
for durability • Designed for VIV
 ow-profile geometry,
L
AOA™ to mitigate
—
•
radiopacity
calcification†
—  ver 20 years of clinical
O
use on Medtronic surgical
tissue portfolio

No clinical data is available that evaluates the long-term impact of AOA treatment in patients.
†
AVALUS™ VALVE

Durability and performance

Non-deformable “firm” base frame

•  aintain valve circularity during
M
and after implant
•  olymer-base frame with barium
P
sulfate for radiopacity

Dual-component
polymer frame
• Strength and flexibility
Tri-leaflet “flexible” support frame • Minimize stress on leaflets

• Flexible stent posts • Resist permanent deformation

— Mitigate leaflet high-stress zones

— Resist permanent deformation
— Minimize central regurgitation
AVALUS™ VALVE

Valve design fatigue testing

PowerPoint slide is
on FOLIO to share
with customers

Stent post Structural

deflection integrity
Quantitative assessment of Fatigue testing to 600 M
deflection as a function of cycles or 15 years
differential pressure for all sizes

Based on bench test data on file and may not be indicative of clinical performance. Sample sizes and test conditions are based on ISO 5840 Standard. Images used with permission. No further distribution permitted.
AVALUS™ VALVE

Hemodynamic performance

1
2
3
1 12 4
11 5 12
2 6
10 7 8 9 10 11
3
4 9
5 6 7 8

Laser-cut holes in the leaflet are aligned Central plug used to

with corresponding holes in the stent align leaflets
• Facilitates consistent valve assembly •  roduces consistently
P
• Translates
sized central hole
into consistent leaflet and
meeting specification
hemodynamic performance
• Translates into consistent
leaflet and hemodynamic
performance

Images used with permission. No further distribution permitted.

AVALUS™ VALVE

Optimized leaflet design

Avalus valve was designed to:

• Minimize leaflet stress values
• Distribute stress concentrations

Concentrated area of peak stress Distributed area of peak stress

Maximum Maximum
principal stress principal stress
7.000e-01 7.000e-01
6.692e-01 6.698e-01
6.385e-01 6.395e-01
6.077e-01 6.093e-01
5.770e-01 5.790e-01
5.462e-01 5.488e-01
5.155e-01 5.185e-01
4.847e-01 4.883e-01
4.540e-01 4.581e-01
4.232e-01 4.278e-01
3.925e-01 3.976e-01
3.617e-01 3.673e-01
3.310e-01 3.371e-01
3.002e-01 3.068e-01
2.695e-01 2.766e-01
2.387e-01 2.464e-01
2.080e-01 2.161e-01
1.772e-01 1.859e-01
1.465e-01 1.556e-01
1.157e-01 1.254e-01
8.495e-02 9.515e-02
5.419e-02 6.491e-02
2.344e-02 3.467e-02
-7.312e-03 4.424e-03
-3.806e-02 -2.582e-02
21 mm Nexus refined solid – step 200 mm Hg (Model 7) -6.882e-02 21 mm Nexus refined solid – step 200 mm Hg (Model 7) -5.606e-02
Time = 0.045 Time = 0.045
Contours of maximum principal stress Contours of maximum principal stress
min = -0.0688173, at elem# 5020 min = -0.0560604, at elem# 3019
max = 0.755908, at elem# 3039 max = 0.618261, at elem# 3002
AVALUS™ VALVE

AOA™ anti-calcification tissue treatment†

Designed for durability

• AOA has over 20 years of clinical performance
on Medtronic valves
• Utilized across multiple products
• Bovine pericardial
• Porcine root
• Porcine pericardial

Avalus aortic Mosaic™ bioprosthesis Freestyle™ aortic Evolut™ PRO+

bioprosthesis mitral and aortic bioprosthesis transcatheter aortic valve

No clinical data is available that evaluates the long-term impact of AOA™ treatment in patients..
†
AVALUS™ VALVE

AOA™ anti-calcification tissue treatment†

Designed for durability

After fixation AOA treatment After treatment

• Free aldehydes present • AOA covalently bonds • Large AOA molecule slows
with free aldehydes diffusion of calcium into
• Lipids are washed away tissue matrix
• Subsequent storage in
glutaraldehyde allows any
remaining free aldehydes
to crosslink
†
No clinical data is available that evaluates the long-term impact of AOA™ treatment in patients..
AVALUS™ VALVE

AOA™ anti-calcification tissue treatment†

Process steps AOA™ tissue treatment Resilia tissue treatment

Fixation: Fresh tissue treated with glutaraldehyde
for preservation  
Wash: Tissue treatment acts as a surfactant and
removes lipids (a potential nidus for calcification)
 
Bond: Tissue treatment bonds with free
aldehydes and those bonded aldehydes no  
longer are nidus for calcification
Valve storage Stored in a solution of glutaraldehyde; remaining Dry storage
free aldehyde chains continue to link and further
minimize nidus for calcification

Tissue treatment data • In Vivo Hemodynamic, Histologic, and • A Randomized Assessment of an Advanced
Antimineralization Characteristics of the Mosaic Tissue Preservation Technology in the Juvenile
Bioprosthesis1 Sheep Model4
• Evidence of Mitigated Calcification of the Mosaic
Versus Hancock Standard Valve Xenograft in the
Mitral Position of Young Sheep2
• Mechanism of Efficacy of 2-Amino Oleic Acid
for Inhibition of Calcification of Glutaraldehyde-
pretreated Porcine Bioprosthetic Heart Valves3

In vivo clinical experience •  reestyle Aortic Root Bioprosthesis 15-year

F •TheCOMMENCE Study — Resilia Tissue Treatment
Clinical Compendium. ©2016 Medtronic. 2-year Outcomes5
• Mosaic Aortic Bioprosthesis 17-year Clinical
Compendium. ©2018 Medtronic.
• Mosaic Mitral Bioprosthesis Clinical
Compendium. ©2017 Medtronic.
See AOA™ process • 4+ years Avalus bioprosthesis in vivo clinical
@ Medtronic.com/AOA
experience. Data on file.

†
No clinical data is available that evaluates the long-term impact of AOA™ treatment in patients. Chen W, Schoen FJ, Levy RJ. Mechanism of efficacy of 2-amino oleic acid for inhibition of calcification of
3

1
Duarte IG, MacDonald MJ, Cooper WA, et al. In vivo hemodynamic, histologic, and antimineralization glutaraldehyde-pretreated porcine bioprosthetic heart valves. Circulation. July 1994;90(1):323-329.
characteristics of the Mosaic bioprosthesis. Ann Thorac Surg. January 2001;71(1):92-99. Flameng W, Hermans H, Verbeken E, Meuris B. A randomized assessment of an advanced tissue
4

2
Weber PA, Jouan J, Matsunaga A, et al. Evidence of mitigated calcification of the Mosaic versus Hancock preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. January 2015;149(1):340-
Standard valve xenograft in the mitral position of young sheep. J Thorac Cardiovasc Surg. November 345.
2006;132(5):1137-1143. Puskas JD, Bavaria JE, Svensson LG, et al. The COMMENCE trial: 2-year outcomes with an aortic
5

bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. September 1, 2017;52(3):432-439.

 AVALUS™ VALVE

AOA™ anti-calcification tissue treatment†

Intracardiac implants in the juvenile sheep model

Medtronic1 Edwards2

Calcium
Calcium values (µg/mg)
Calcium values (µg/mg)

8.36
reduction
Medtronic and Edwards each
6.8 studied their anticalcification
treatments in the mitral position
of juvenile sheep. In both
1.97 respective studies, AOA and
1.9 Resilia treatments demonstrated
a significant reduction in calcium
compared to the control group.
No treatment AOA-treated Original Edwards Resilia-treated
used on tissue tissue XenoLogiX-treated tissue
tissue

†
No clinical data is available that evaluates the long-term impact of AOA™ treatment in patients.. 1
 eber PA, Jouan J, Matsunaga A, et al. Evidence of mitigated calcification of the Mosaic versus Hancock
W
These tests may not be indicative of clinical performance and are for illustrative purposes only. The charts Standard valve xenograft in the mitral position of young sheep. J Thorac Cardiovasc Surg. November
are not intended to be a comparison of the two devices as there is no head-to-head preclinical animal 2006;132(5):1137-1143.
clinical study, but rather are intended to illustrate the results of two similar animal studies. Multiple factors 2
Flameng W, Hermans H, Verbeken E, Meuris B. A randomized assessment of an advanced tissue
contribute to animal study outcomes and need to be considered in making any assessments across preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. January 2015;149(1):340-
different studies. 345.
AVALUS™ VALVE

Product specifications

Indications for use

The Avalus bioprosthesis is indicated for the replacement of diseased,
damaged, or malfunctioning native or prosthetic aortic valves.

Ordering information
Avalus™ Valve Stent Internal External Valve Aortic
valve size diameter orifice diameter † sewing profile protrusion 1
order (TAD) ring height
number diameter 2
(1) (2) (2a) (3) (4) (5)
40019 19 mm 19 mm 17.5 mm 18 mm 27.0 mm 13.0 mm 11.0 mm
5
40021 21 mm 21 mm 19.5 mm 20 mm 29.0 mm 14.0 mm 12.0 mm
4
40023 23 mm 23 mm 21.5 mm 22 mm 31.0 mm 15.0 mm 13.0 mm
40025 25 mm 25 mm 23.5 mm 24 mm 33.0 mm 16.0 mm 14.0 mm
3
40027 27 mm 27 mm 25.5 mm 26 mm 36.0 mm 17.0 mm 15.0 mm

Accessories
Order number Description
7420 Valve handle
7400S Avalus sizers
T7400 Tray, accessory, Avalus™

TAD – Tissue Annulus Diameter

†
Measurement shows stent frame including tissue (2) and stent frame excluding tissue (2a).
AVALUS™ VALVE

Avalus Bioprosthesis

INDICATIONS: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

CONTRAINDICATIONS: None known.

WARNINGS/PRECAUTIONS/ADVERSE EVENTS: Only physicians who have received proper training in valve replacement should use this device. Accelerated structural
deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic
renal failure, or hyperparathyroidism). Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage,
infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural valve dysfunction (leaflet entrapment/impingement, obstructive
pannus ingrowth, suture dehiscence, inappropriate sizing or positioning, or other), pericardial effusion or tamponade, prosthesis regurgitation, prosthesis stenosis,
prosthesis thrombosis, stroke, structural valve deterioration (calcification, leaflet tear or perforation, or other), thromboembolism, tissue dehiscence, and transient
ischemic attack. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, warnings, and
potential adverse events, please refer to the Instructions for Use. For countries that use eIFUs, consult instructions for use at medtronic.com/manuals.

NOTE: Manuals can be viewed using a current version of any major internet browser.
Relevant clinical studies
Durability and performance of Trifecta™
aortic valve prostheses
Distortion of bioprosthesis ring
Impact of clinically relevant elliptical deformations
Comparison of internally versus externally mounted leaflets
Comparison of safety and hemodynamic performance
Sizing strategy and implant considerations for the Avalus™ valve
CLINICAL STUDY

Durability and performance of 2,298 Trifecta™* aortic valve protheses:

a propensity-matched analysis
Yongue C, Lopez D, Soltesz E, et al. Ann Thorac Surg. 2021;111:1198-206.

Method:
Trifecta patients are propensity matched to a cohort of Perimount™* patients with 2,298 matches.

Results:
Trifecta has more favorable early hemodynamics but “… exhibits a more rapid increase in transvalvular
gradients, more regurgitation, and lower freedom from explant at five years.”
Risk of explant was three times greater for Trifecta at five years (4.1% versus 1.3% for Perimount).

Hemodynamics over time Probability of reoperation and freedom from SVD

20 Change in gradient 10 Change in AR 5

Trifecta
Mean gradient (mm Hg)

AR grade: severe (%)

8 4

Aortic valve-related
Perimount

reoperation (%)
15
6 3

4 2 Perimount
10 Trifecta
Trifecta
2 1
Perimount
5 0 0
0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5
Years Years Years
Trifecta 2298 1255 1147 1049 879 730
Perimount 2298 1260 1038 769 543 353
CLINICAL STUDY
Durability and performance of 2,298 Trifecta™* aortic valve protheses:
a propensity-matched analysis, cont’d.
Considerations
•  etrospective review of 2,305 Trifecta
R •
patients with outcomes compared to 17,281
Perimount™* patients at the Cleveland Clinic
—  iven both the retrospective nature and
G
difference in enrollment periods, 2007–2017
and 1982–2017 for Trifecta and Perimount
respectively, propensity matching was used with
2,298 patients with each valve compared.
• Age, sex, functional
class, pathologies, size
mix, and other demographics were similar.
• “Early trends”
— “ At 5 years, 4.1% of Trifecta valves had been
explanted versus 1.3% of Perimount valves.
Although the absolute values are small, the
relative risk is significant, especially considering
that the Trifecta valve has markedly better early
hemodynamic performance. Evidence of such a
trend at as early as five years is concerning for the
long-term durability of the Trifecta valve.”
Failure modes
— The primary mode of failure was increased
gradient secondary to calcific degeneration.
Failure due to AR (tear) was less common.
• Limitations
— Trifecta patients with < five years of follow-up had
slightly higher risk factors for SVD in smoking,
renal disease, and diabetes. However, the bulk
of explants were in patients with ≥ five years of
follow-up.
—  ollow-up was rigorous but was limited by patient
F
relocation, death, and opting out of follow-up.
Statistical tools were used for missing
data values.
• Trifecta versus Trifecta GT
— Another limitation is that there was “proportionally
less information” available on the Trifecta GT.
However, the authors note that differences
between Trifecta and Trifecta GT are changes to
the struts and cusp suturing. These are changes
that would impact mechanical durability but “ …
may unlikely prevent early failures” that are calcific
in nature, leading to decreased systolic efficiency,
e.g., increased gradient.
CLINICAL STUDY

Is distortion of the bioprothesis ring a risk factor for

early calcification?
Cereijo JM, et al. J Cardiothorac Surg. 2010;5:77.

Method: 100

Cumulaetd survival (%)

Calcification and mechanical stress in bioprosthetic 80

tissue is interrelated. In this study, the authors 60

speculate that distortion of the valve and altered 40

leaflet geometry resulted in higher mechanical stress 20 Patients at risk

and that this is related to calcification of the valve. 0
446 280 217 155 117 88 56 26 16 8 1

0 1 2 3 4 5 6 7 8 9 10

Results:
Years
FIG. 1

This group previously described early calcification Freedom from SVD1

with the Mitroflow™* Model 12 valve in a patient

cohort > 70 years of age.1 32 of 510 patients
experienced SVD. Freedom from reoperation for
SVD was 95% ± 3% at five years and 55.8% ± 2% at
10 years (Fig. 1).
•A
 ll failures had extensive calcification, with the right
coronary leaflet most often the most calcified (Fig. 2).
•C
 hest radiographs of all patients showed bioprostheses
with a noncircular, irregular ring. FIG. 2 FIG. 3
Explant with distortion Pre-operative angiography
•A
 distorted bioprosthesis ring was detected in all and right coronary showing distorted ring
leaflet calcification
preoperative angiographies prior to explant (Fig. 3).

1
Alvarez JR, Sierra J, Vega M, et al. Early calcification of the aortic Mitroflow pericardial bioprosthesis in the elderly. Interact CardioVasc Thorac Surg 2009;9:942-846.
Images used with permission. No further distribution permitted.
CLINICAL STUDY

Is distortion of the bioprothesis ring a risk factor

for early calcification? cont’d.

Considerations
• Mechanical stress in bioprosthetic tissue has long been linked to calcification.1-2
• The authors previously reported calcification of the Mitroflow™* Model 12 in elderly patients
(> 70 years).3
— B
 ioprosthetic dysfunction, particularly SVD, is lower in elderly patients.3-4

•  tructural valve dysfunction (SVD): Any clinically relevant valvular stenosis (area -0.8 cm, mean
S
2 gradient at rest, 40 mm Hg) or insufficiency documented by echo-Doppler with bioprosthetic
calcification confirmed at reoperation.3
• Limitation
— T
 his is a single-center observation of the Model 12 valve.

1
Schoen F, Levy R. Calcification of tissue heart valve substitutes: progress toward understanding and prevention. Ann Thorac Surg. March 2005;79(3):1072-1080.
2
Thubrikar MJ, Deck JD, Aouad J, et al. Role of mechanical stress in calcification of aortic bioprosthetic valves. J Thorac Cardiovasc Surg. July 1983;86(1):115-125.
3
Alvarez JR, Sierra J, Vega M, et al. Early calcification of the aortic Mitroflow pericardial bioprosthesis in the elderly. Interact Cardiovasc Thorac Surg. November 2009;9(5):842-846.
Head JS, Çelik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J. July 21, 2017;38(28):2183-2191.
4
CLINICAL STUDY

The impact of clinically relevant elliptical deformations on the damage

patterns of sagging and stretched leaflets in a bioprothesis heart valve
Sritharan D, Fathi P, Weaver JD, et al. Cardiovasc Eng Technol. 2018 Sep 9; (3):351-364. doi: 10.1007/s13239-018-0366-x. Epub 2018 Jun 12. PMID:  29948838.

Method: Distortion was

done in either a
major axis
minor or major
This in vitro study was undertaken to determine axis orientation
the impact on a bioprosthesis when forced out of
round by the native annulus geometry, e.g., made minor
axis
elliptical. The authors studied Carpentier-Edwards
Perimount™* (2800) surgical valves with altered
inflow geometry subjected to accelerated wear
testing (AWT). Post-AWT valve tissue was examined, Examples of tissue failure from major axis distortion

mechanically characterized, and hydrodynamic

performance was assessed. CT

Results:
•  eaflet thinning, tears, and commissural
L
FTsag
tears/dehiscence and damage to the leaflet-free
edges were observed.
• Regurgitant fractions exceeded ISO performance
criteria of 15%.

FTstretch

Images used with permission. No further distribution permitted.

CLINICAL STUDY

The impact of clinically relevant elliptical deformations on

the damage patterns of sagging and stretched leaflets in a
bioprothesis heart valve, cont’d.

Considerations
• Why this study?
—T
 he authors had observed that when stented bioprosthetic valves are subject to AWT testing in their
circular geometry, they demonstrate good durability.
—H
 owever, altered leaflet motion and opening/closing asymmetry can lead to structural valve
deterioration. There is little data on modes of valve damage associated with altered leaflet geometry due
to noncircularity of prosthesis.
• Results
— D
 ifferent modes of failure were demonstrated for specific valvular distortions.

• Limitations
— C
 linically, surgical valves would not see the amount of distortion applied on the test rigs. However,
the leaflet damage that was observed here is “… consistent with clinical evidence of fatigue-induced
pericardial leaflet tears.”
CLINICAL STUDY

An in vitro comparison of internally versus externally

mounted leaflets in surgical aortic bioprostheses

Method: Hydrodynamics
50
• To study the impact of valve design, Avalus Magna Ease Trifecta

Rregurgitant fraction (%)

40
hydrodynamic performance and mechanical
30
durability were compared in vitro between
pericardial aortic valves with internally mounted 20

leaflets (IMLV) and externally mounted leaflets 10

(EMLV). 0
Baseline 200 400 500 600
— Avalus and Perimount Magna Ease were
™ ™*
Number of cycles (per million)
representative of internally mounted valves. Trifecta™* Mechanical durability
was representative of externally mounted valves. Valves after 600 million cycles. Wear areas circled.

— Valves were subject to accelerated wear testing

between 10 and 20 Hz for 600 million cycles
with inspection at fixed intervals. Valves were
hydrodynamically tested (mean gradient, EOA, and
regurgitant fraction) at similar intervals.
Results:
• Hydrodynamics
— Trifecta™*demonstrated superior hemodynamic
performance (mean gradient and EOA).
— Regurgitant was similar at baseline but increased
significantly for Trifecta at 500 and 600 million cycles
secondary to tissue damage.
Images used with permission. No further distribution permitted.
Trifecta Magna Ease Avalus
• Mechanical durability:
— Trifectaexhibited inferior mechanical durability
with major abrasion damage occurring in 5/9 of
the Trifecta valve, resulting in at least one tear or
hole at the commissures.
— All Magna Ease and Avalus valves completed 600
million cycles with minimal tissue wear.
CLINICAL STUDY

An in vitro comparison of internally versus externally

mounted leaflets in surgical aortic bioprostheses, cont’d.

Considerations
• Valves tested
— T
 hree of each valve model in sizes 19, 21, and 23.

• In vitro testing methodology

— P  er ISO 5840.1-2
—V  alves cycled between 10 and 20 Hz at a minimum of 100 mm Hg.
— I nspections (visual and hydrodynamic) were 50 million cycle intervals to 200 million and 200 million

intervals thereafter.
—6  00 million cycles simulates 15 years.

• Limitations
—I n vitro simulation with saline versus blood cannot simulate immunologic reaction so that lipid uptake,
calcification, etc., are not simulated.
—T  he conditions of the accelerated rate of testing generates nonphysiologic flow.
—R  esearch was performed at a Medtronic test facility, pericardial leaflet tears.

1
ISO 5840-1:2015 Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements. International Organization for Standardization.
Available at: https://www.iso.org/standard/61732.html. Accessed January 6, 2022.
2
ISO 5840-1:2015 Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes. International Organization for Standardization.
Available at: https://www.iso.org/standard/51314.html. Accessed January 6, 2022.
CLINICAL STUDY

Comparison of safety and hemodynamic performance between

the Avalus™ stented aortic valve bioprosthesis and Magna™* valve
in Japanese patients
Tadokoro N,  Fukushima S, Shimahara Y, et al. Gen Thorac Cardiovasc Surg. January 5, 2021. doi: 10.1007/s11748-020-01566-1. Epub ahead of print. PMID: 33400197. 

Method:
• This
study characterizes and compares the Avalus and Magna valves in patients with
small body sizes. More than 80% of the implants were ≤ size 23.

Results:
• There were no significant differences between groups for early or late outcome.
—  small valves such as the 19 or 21-mm valves produced an MPG and EOA similar to that of the
…
Magna valves and resulted in good functionality in patients with a small body size.
— Severe patient-prosthesis mismatch was similar in both groups.

Mean pressure gradient (mm Hg) at 1-year follow-up Effective orifice area (cm2) at 1-year follow-up
19 mm 1Y 21 mm 1Y 23 mm 1Y 25 mm 1Y 27 mm 1Y 19 mm 1Y 21 mm 1Y 23 mm 1Y 25 mm 1Y 27 mm 1Y
30 30 *
* 30 * 30 30 3 3 3 3 3
*
* *
*
*
20 20 20 20 *
20 *
2 2 *
2 2 2
**

10 10 10 10 10 1 1 1 1 1

0 0 0 0 0 0 0 0 0 0
Avalus Magna Avalus Magna Avalus Magna Avalus Magna Avalus Magna Avalus Magna Avalus Magna Avalus Magna Avalus Magna Avalus Magna
(n=13) (n=51) (n=14) (n=97) (n=9) (n=72) (n=6) (n=40) (n=3) (n=18) (n=13) (n=51) (n=14) (n=97) (n=9) (n=72) (n=6) (n=40) (n=3) (n=18)

Study cohorts: Avalus 87, Magna 381

CLINICAL STUDY

Comparison of safety and hemodynamic performance between

the Avalus™ stented aortic valve bioprosthesis and Magna™* valve
in Japanese patients, cont’d.

Considerations
• Avalus PERIGON study for regulatory approvals enrolled patients in the United States, Canada,
and Europe with an average BSA of 2.0 cm2. Conversely, in Japan, the population is typically
smaller; in this study, BSA for both cohorts was 1.6 cm2. The authors studied the feasibility
(sizing, implantability), hemodynamics, and safety of Avalus in the smaller Japanese population.
• In this single-center study, Avalus (n = 87) results were compared retrospectively to the
institution’s contemporary Magna (n = 381) use and experience.
— T
 here were significant differences between cohorts in hypertension, HbA1C, kidney function, the NYHA
functional class, and valve pathology. There were no significant differences in age, sex, BSA, and BMI.
• Limitations
—R
 etrospective study design with a small number of patients.
—V
 alve choice was not randomized, however, because the Avalus valve was the primary choice of
bioprosthetic valve during the study period, the study bias related to patient selection was minimal.

1
ISO 5840-1:2015 Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements. International Organization for Standardization.
Available at: https://www.iso.org/standard/61732.html. Accessed January 6, 2022.
2
I ISO 5840-1:2015 Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes. International Organization for Standardization.
Available at: https://www.iso.org/standard/51314.html. Accessed January 6, 2022.
 CLINICAL STUDY

Sizing strategy and implant considerations for the Avalus™ valve

Moront MG, Sabik JF 3rd, Reardon MJ, Dagenais F, Lange R, Walther T, Kerendi F, Klautz RJM. Ann Thorac Surg. 2020 Dec;110(6):e551-e553. doi: 10.1016/j.athoracsur.2020.04.103. Epub 2020 Jun 12. PMID: 32540438.

Adherence to these sizing considerations resulted in an overall mean gradient and EOA at one year after implant of
12.5 ± 4.4 mm Hg and 1.5 ± 0.4 cm2, and are comparable to those from the contemporary COMMENCE study.

30 2.5

24.0 1.77 2.01

Mean effective orifice area (cm2)

25
17.1
1.47 1.57
2
Mean gradient (mm Hg)

14.5
20

12.1 11.7 1.25

10.3
1.5
1.11
15
9.8
1

0.62
10

0.5
5

0 0

17 mm 19 mm 21 mm 23 mm 25 mm 27 mm 29 mm 17 mm 19 mm 21 mm 23 mm 25 mm 27 mm 29 mm
(n= 1) (n = 27) (n = 106) (n = 205) (n = 170) (n = 43) (n = 5) (n = 1) (n = 25) (n = 99) (n = 201) (n = 167) (n = 41) (n = 5)

Labeled valve size Labeled valve size

CLINICAL STUDY

Avalus Bioprosthesis

INDICATIONS: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

CONTRAINDICATIONS: None known.

WARNINGS/PRECAUTIONS/ADVERSE EVENTS: Only physicians who have received proper training in valve replacement should use this device. Accelerated structural
deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic
renal failure, or hyperparathyroidism). Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage,
infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural valve dysfunction (leaflet entrapment/impingement, obstructive
pannus ingrowth, suture dehiscence, inappropriate sizing or positioning, or other), pericardial effusion or tamponade, prosthesis regurgitation, prosthesis stenosis,
prosthesis thrombosis, stroke, structural valve deterioration (calcification, leaflet tear or perforation, or other), thromboembolism, tissue dehiscence, and transient
ischemic attack. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, warnings, and
potential adverse events, please refer to the Instructions for Use. For countries that use eIFUs, consult instructions for use at medtronic.com/manuals.

NOTE: Manuals can be viewed using a current version of any major internet browser.
PERIGON Trial
Avalus™ PERIGON five-year clinical data
PERIGON and COMMENCE studies
Study characteristics
Inclusion criteria
Exclusion criteria
Baseline characteristics
Valve size distribution
Diagnosis for replacement
Concomitant procedures
NYHA classifications
Clinical outcomes
Hemodynamic outcomes
Hemodynamic parameters by valve size
Similarities
PERIGON TRIAL

Avalus™ PERIGON five-year clinical data

The PERIGON Pivotal Trial was designed to evaluate the safety and effectiveness of the Model 400 (Avalus)
bovine pericardial stented aortic bioprosthesis in a patient population undergoing surgical aortic valve
replacement. Patients were from Canada (268), Europe (475), and the United States (375). Of the 1,287 patients
enrolled, 1,118 were implanted with the Avalus™ valve. At five years, the Avalus valve has shown 0 SVD.

Valve size distribution Kaplan-Meier survival analysis Echocardiographic findings

Freedom from event rate for all-cause mortality
and structural valve deterioration

401
100%
450 100%
(35.9%) 45 1.8
90%
42.1 1.6 1.6
400 350
40 1.5 1.5 1.5 1.5 1.6
(31.3%) 80% 88.1% 1.4
Freedom-from-event rate

350

Effective orifice area (cm²)

35 1.4

Mean gradient (mm Hg)

70%
300 30 1.2
# of valves

60%
211
250
(18.9%) 25 1
50% 0 SVD
200 0.9
40% through 20 0.8
150 101 5 years 15 13.1 12.7 13 13 0.6
30% 11.9 12.6 12.5
(9.0%)
100 42 20% 10 0.4
(3.8%) 12 All-cause mortality
50 1 10% 1,089 1,074 1,048 1,014 956 868 727 429
(1.1%) Structural valve deterioration 5 0.2
(0.1%) 1,016 950 998 979 911 809 628 356
0 0%
0 0
17 mm† 19 mm 21 mm 23 mm 25 mm 27 mm 29 mm† 01 6 12 18 24 30 36 42 48 54 60
Baseline Discharge 3–6 1 year 2 year 3 year 4 year 5 year
Months post-procedure 30 days months
†
Not commercially available in the United States. Number of
subjects 1,118 1,108 1,081 1,059 1,018 961 782 464
at risk: 1,118 1,108 1,081 1,059 1,018 961 782 463 Mean gradient (mm Hg) Effective orifice area (cm²)

‡
Data are not paired.

PERIGON Pivotal Trial data on file as of October 2021.

PERIGON TRIAL

Avalus™ PERIGON five-year clinical data

Baseline demographics Procedural data

Patient characteristics N = 1,118 Procedural characteristics N = 1,118

Age, years 70.2 ± 9.0 Primary indication

Male sex 75.1% Aortic stenosis 84.3%

BSA, m2 2.0 ± 0.2 Aortic regurgitation 5.7%

STS risk of mortality 2.0 ± 1.4% Mixed AS/AR 9.5%

NYHA class I/II 57.8% Surgical approach

NYHA class III/IV 42.2% Median sternotomy 79.6%

Atrial fibrillation 10.5% Less invasive approach 20.4%

Coronary artery disease 43.6% Concomitant CABG 32.4%

PERIGON Pivotal Trial data on file as of January 2021.

PERIGON TRIAL

Avalus™ PERIGON five-year clinical data

Transvalvular regurgitation NYHA classification

All valve sizes.‡ All valve sizes.‡

0.1% 0.1% 0.1% 0.2% 0.1% 0.3% 2.9% 0.1% 0.1% 0.1% 0.3% 0.2%
100% 4.2% 4.2% 3.8% 0.1% 3.0% 4.2% 0.7% 5.4% 4.7% 100% 3.2% 3.3% 3.3%
3.5% 4.2%
6.4% 4.3% 3.7% 4.2%
90% 11.5% 11.0% 9.2%
90%
23.5% 20.7% 22.3% 21.3% 22.7% 24.2%
80% 80%
70% Severe 70%

% of subjects
% of subjects

60% Moderate 60% IV

50% 91.1%
Mild 50% III
84.2% 84.7% 86.8% 90.4% 90.8% 90.7%
40% Trace 40%
76.0% 74.1% 75.3% 73.8%
II
73.5% 71.4%
None I
30% 30%
20% 20%
10% 10%
0% 0%
Discharge 3–6 1 year 2 year 3 year 4 year 5 year 3–6 1 year 2 year 3 year 4 year 5 year
30 days months months
‡
Data are not paired. ‡
Data are not paired.

> 95% of > 95% of

subjects had less subjects
than mild central reported NYHA
regurgitation at class I or II at
5 years 5 years

PERIGON Pivotal Trial data on file as of October 2021.

PERIGON TRIAL

PERIGON and COMMENCE studies

Study characteristics
The trials were similar in regard to study design, endpoints, and methods. This must be taken
into account when synthesizing the clinical trial data available from these contemporary studies.

PERIGON Trial COMMENCE Trial

Prospective, nonrandomized, single arm Study design Prospective, nonrandomized, single arm

1,118 patients AVR patients 694 patients

38 sites in U.S., Canada, Europe Clinical trial sites 27 sites in U.S. and Europe

Avalus™ = 100% SAVR valve used Magna Ease™* with Resilia = 100%‡
All-cause, cardiac, and valve-related death,
and valve-related thromboembolism,
Subjects with structural valve deterioration
thrombosis, all and major hemorrhage, all Primary endpoint
at 1 year
and major paravalvular leak, and
endocarditis
May 2014 – July 2017† Enrollment period January 2013 – February 2016

12 years Planned follow-up duration 10 years

†
For sizes 17-27, 29 mm still enrolling in the United States.
The Inspiris valve was not used in this clinical trial.
‡

These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies. See references on page 47.
PERIGON TRIAL

PERIGON and COMMENCE studies

Inclusion criteria
Both trials had inclusion criteria including informed consent and moderate or severe AS or AR,
redo AVR, and concomitant procedures.

Key inclusion
PERIGON Trial COMMENCE Trial
• Informed consent • Informed consent
• Moderate or severe AS or AR and indication for • 18 years or older
replacement • Diagnosed with aortic valve disease
• Some concomitant procedures were allowed • Some concomitant procedures allowed: CABG,
• Redo AVR were included ascending aorta, atrial fibrillation procedures,
myectomy
• Redo AVR operations included
• Agreed to attend all follow-up assessments for
five years

These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies. See references on page 47.
PERIGON TRIAL

PERIGON and COMMENCE studies

Exclusion criteria
Both trials had similar exclusion criteria with few differences.

Key inclusion
PERIGON Trial COMMENCE Trial
•  re-existing prosthetic valve or annuloplasty device
P • Emergency surgery
in another position or need for replacement • Active endocarditis/myocarditis or endocarditis/
• Active endocarditis, active myocarditis, or other myocarditis within three months to the scheduled
infection AVR surgery
• Noncardiac major progressive disease with life • Multiple valve replacement/repair required
expectancy < 2 years • Prior valve surgery, which included implant
• Emergency surgery (adopted this early in study) of a bioprosthesis valve, mechanical valve, or
• Renal failure (defined as dialysis therapy or annuloplasty ring that will remain in situ
glomerular filtration rate < 30 mL/min/1.73 m2) • Has renal insufficiency as determined by creatinine
• Acute preoperative neurological deficit or (S-Cr) level ≥ 2.5 mg/dL or end-stage renal disease
myocardial infarction with no return to baseline or requiring chronic dialysis at screening visit
stabilization ≥ 30 days before enrollment • Has MRI or CT scan-confirmed stroke,
cerebrovascular accident (CVA), or transient
ischemic attack (TIA) within 6 months (180 days)
prior to planned valve surgery
• Diagnosed with abnormal calcium metabolism
and hyperparathyroidism

These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies. See references on page 47.
PERIGON TRIAL

PERIGON and COMMENCE studies

Baseline characteristics
Baseline characteristics between patients enrolled in the trials had limited variation, as expected.
Patients in the PERIGON Trial were more likely to be NYHA class III or IV.

PERIGON Trial: n = 1,118 COMMENCE Trial: n = 689

Age 70.2 ± 9.0 Age 67.0 ± 11.6
Female sex 25.0% Female sex 28.2%
NYHA class III or IV 42.3% NYHA class III or IV 26.3%
STS-PROM 2.0 STS-PROM 2.0
BMI > 30 kg/m2 40.2% BMI > 30 kg/m2 43.7%
CAD 42.1% CAD 55.7%
Previous MI 8.9% Previous MI 7.8%
CHF 19.9% CHF 22.2%
LVEF NA LVEF NA
AVA 0.9 AVA NA

These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinicalstudy outcomes and need to be considered in making any assessments across different studies. See References on page 47.
PERIGON TRIAL

PERIGON and COMMENCE studies

Valve size distribution

Valve sizes used were primarily 21 mm, 23 mm, and 25 mm.

Valve size (%)

PERIGON Trial COMMENCE Trial
17 mm† 0.1 17 mm NA
19 mm 3.8 19 mm 3.2
21 mm 18.9 21 mm 19.0
23 mm 35.9 23 mm 31.1
25 mm 31.3 25 mm 29.3
27 mm 9.0 27 mm 14.5
29 mm 1.1 29 mm 2.9

17 mm valve not available in United States. Only available in Japan.

†

These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies. See references on page 47.
PERIGON TRIAL

PERIGON and COMMENCE studies

Diagnosis for replacement

Diagnosis for aortic valve replacement was similar. However, more patients with mixed valve
disease were included in COMMENCE.

Diagnosis (%)
PERIGON Trial COMMENCE Trial
Stenosis 84.3 Stenosis 51.0

Stenosis with insufficiency 9.4 Stenosis with insufficiency 38.8

Pure insufficiency 5.7 Pure insufficiency 6.8

Prosthetic valve dysfunction 0.5 Prosthetic valve dysfunction 2.5

Other diagnosis 0.9

These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies. See references on page 47.
PERIGON TRIAL

PERIGON and COMMENCE studies

Diagnosis for replacement

Patient etiology were primary degenerative in both trials, with about a third of patients also
having congenital disease.

Etiology (%)
PERIGON Trial COMMENCE Trial
Degenerative 72.6 Degenerative 80.3

Congenital 29.5 Congenital 30.1

Rheumatic 1.3 Rheumatic 3.6

Resolved endocarditis 0.5 Remote endocarditis 0.9

Other 4.0 Other 3.6

These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies. See references on page 47.
PERIGON TRIAL

PERIGON and COMMENCE studies

Concomitant procedures
Concomitant procedures occurred in both trials.

Procedures (%)
PERIGON Trial COMMENCE Trial
CABG 32.4 CABG 24.4
Resection of subaortic membrane not requiring myectomy 1.9 1 graft 13.1
Ascending aortic aneurysm not requiring circulatory arrest 7.6 2 grafts 5.1
Annular enlargement 4.6 3 grafts 4.4
Aortic root/STJ enlargement 13.8 4+ grafts 0.0
LAA closure 7.8 Aortic aneurysm 4.9
PFO closure 1.2 Atrial ablation 3.0
Other 20.2 Ascending aorta replacement 1.2
Root sinus enlargement 2.2
Annular enlargement 1.3
Atrial septal defect repair 2.2
Permanent pacemaker 0.0
Other 10.6

These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies. See references on page 47.
PERIGON TRIAL

PERIGON and COMMENCE studies

New York Heart Association (NYHA) classificactions

PERIGON COMMENCE (5-year NYHA not reported)

0.1% 0.2% 0.4%

2.0% 3.2% 4.2% 1.9% 1.6%
100% 100%

90% 90%
24.4% 17.3%
20.7% 24.2%
80%
40.3% 80%

70% 70%
Calcium values

NYHA class, %
I I
60% 60%

50%
II 50% 49.6% II

40% III 40% III

30%
46.8% 76.0% 71.4% IV 30%
80.7% IV
20% 20%

24.1%
11.0% 11.0% 11.0% 11.0%
10% 10%

0% 0%
Baseline 1 year 5 Years Baseline 1 year

These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies. See references on page 47.
PERIGON TRIAL

PERIGON and COMMENCE studies

Five-year clinical outcomes

Clinical outcomes at five years showed low rates of complications. Like all trials, direct
comparison of event rates between trials are challenging since the trials were not designed to
compare device types and differences in patient numbers, analysis type, or endpoint definitions.

PERIGON Trial: 5 Year (N = 1118) COMMENCE Trial: 5 Year (N = 499)

Outcome Freedom from (%) Outcome Probability event free (%)
Valve-related mortality 98.5 All-cause mortality 89.2
Cardiac mortality 97.9 Reoperation 98.7
All-cause mortality 88.1 Stroke 94.5
SVD 100.0 Valve thrombosis 100.0
NSVD 98.5 Major bleeding 94.3
Major PVL 99.5
Linearized late SVD 100.0
event rate (%) NSVD (other than PVL) 100.0
Valve thrombosis 0.06 Endocarditis 97.8
Major hemorrhage 1.3
Major PVL 0.02
Endocarditis 0.9

These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies. See references on page 47.
PERIGON TRIAL

PERIGON and COMMENCE studies

Hemodynamic outcomes
PERIGON Trial
Follow-up Discharge 2 Years 5 Years
Mean gradient (mm Hg) 13.1 ± 4.7 13.4 ± 5.0 12.5 ± 4.6
Valve area (cm2) 1.6 ± 0.4 1.5 ± 0.4 1.4 ± 0.4
None/trace PVL (%) 98.0 96.2 97.4
Mild PVL (%) 2.0 3.3 2.6
Moderate PVL (%) 0.0 0.4 0.0
Severe (%) 0.0 0.1 0.0

COMMENCE Trial
Follow-up Discharge 2 Years 5 Years
Mean gradient (mm Hg) 10.7 ± 5.0 10.2 ± 4.5 11.5 ± 6.0
Valve area (cm2) 1.9 ± 0.6 1.6 ± 0.5 1.6 ± 0.5
None/trivial PVL (%) 99.8 94.5 97.8
Mild PVL (%) 0.2 4.9 2.2
Moderate PVL (%) 0.0 0.5 0.0
Severe PVL (%) 0.0 0.0 0.0

These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies. See references on page 47.
PERIGON TRIAL

PERIGON and COMMENCE studies

Hemodynamic parameters by valve size

PERIGON
19 mm 21 mm 23 mm 25 mm 27 mm 29 mm
Parameter
Mean ± SD (n†) Mean ± SD (n†) Mean ± SD (n†) Mean ± SD (n†) Mean ± SD (n†) Mean ± SD (n†)
1 year
Mean gradient
17.1 ± 5.0 (27) 14.5 ± 4.3 (106) 12.1 ± 3.8 (205) 11.7 ± 4.0 (170) 10.3 ± 4.2 (43) 9.8 ± 3.1 (5)
(mm Hg)
1.47 ± 0.32 1.57 ± 0.31 1.77 ± 0.41 (41)
EOA (cm ) 2
1.11 ± 0.25 (25) 1.25 ± 0.25 (99) 2.01 ± 0.23 (5)
(201) (167)

COMMENCE
19 mm 21 mm 23 mm 25 mm 27 mm 29 mm
Parameter
Mean ± SD (n†) Mean ± SD (n†) Mean ± SD (n†) Mean ± SD (n†) Mean ± SD (n†) Mean ± SD (n†)

1 year

Mean gradient NA (data not

17.6 ± 7.8 (16) 12.6 ± 4.7 (97) 10.1 ± 3.8 (158) 9.6 ± 5.2 (132) 8.2 ± 3.5 (69)
(mm Hg) reported at 1 year)

NA (data not
EOA (cm2) 1.1 ± 0.2 (16) 1.3 ± 0.3 (97) 1.6 ± 0.4 (155) 1.8 ± 0.5 (131) 2.2 ± 0.6 (68)
reported at 1 year)

†
n represents the number of subjects with evaluable data.
These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies. See references on page 47.
PERIGON TRIAL

PERIGON and COMMENCE studies

Similarities
• Study design, methods, and endpoints
• Exclusion and inclusion criteria
• Baseline characteristics
• Procedural characteristics
• Hemodynamic outcomes
• Clinical outcomes at 30 days, two years, and five years
• Mid-term (five year) safety, durability, and valve
performance
PERIGON TRIAL

References

Bartus K, Litwinowicz R, Bilewska A, et al. Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis. Eur J Cardiothorac Surg.
January 29, 2021;59(2):434-441.

Dagenais F, Moront MG, Brown WM, et al. Safety, efficacy, and hemodynamic performance of a stented bovine pericardial aortic valve bioprosthesis:
Two-year analysis. J Thorac Cardiovasc Surg. August 2020;160(2):371-381.e4

Johnston DR, Griffith BP, Puskas JD, et al. Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue. J Thorac Cardiovasc Surg.
November 2021;162(5):1478-1485.

Klautz RJM, Kappetein AP, Lange R, et al. Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. Eur J Cardiothorac Surg.
September 1, 2017;52(3):425-431.

Puskas JD, Bavaria JE, Svensson LG, et al. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg.
September 1, 2017;52(3):432-439.

Sabik 3rd JF, Rao V, Lange R, et al. One-year outcomes associated with a novel stented bovine pericardial aortic bioprosthesis. J Thorac Cardiovasc Surg.
October 2018;156(4):1368-1377.e5.
PERIGON TRIAL

Avalus Bioiprothesis

INDICATIONS: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning  native or prosthetic aortic valves.

CONTRAINDICATIONS: None known.

WARNINGS/PRECAUTIONS/ADVERSE EVENTS: Only physicians who have received proper training in valve replacement should use this device. Accelerated structural
deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic
renal failure, or hyperparathyroidism). Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage,
infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural valve dysfunction (leaflet entrapment/impingement, obstructive
pannus ingrowth, suture dehiscence, inappropriate sizing or positioning, or other), pericardial effusion or tamponade, prosthesis regurgitation, prosthesis stenosis,
prosthesis thrombosis, stroke, structural valve deterioration (calcification, leaflet tear or perforation, or other), thromboembolism, tissue dehiscence, and transient
ischemic attack. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. For countries that use eIFUs,
consult instructions for use at medtronic.com/manuals.

NOTE: Manuals can be viewed using a current version of any major internet browser.
Surgical valve therapies portfolio
Tissue
Mechanical
Repair
SURGICAL VALVES THERAPIES PORTFOLIO

Tissue

Complete portfolio based on surgeon preference and patient needs

Hancock™ II Mosaic™ Freestyle™ Avalus™ Stented Bovine

Stented Porcine Valve Stented Porcine Valve Stentless Porcine Valve Pericardial Valve

• Flexible polymer stent • Flexible polymer stent
• Cinch™ implant system • AOA™ anti-calcification†
• T6 anti-calcification • Physiologic fixation
• Low-pressure fixation • Low failure rates
• Cinch™ implant system
• Native valve design • Next-gen bovine valve
• AOA anti-calcification† • AOA anti-calcification†
• Physiologic fixation • Laser-cut leaflets
• Multiple configurations • MRI-safe valve

No clinical data is available that evaluates the long-term impact of AOA™ treatment in patients.
†
SURGICAL VALVES THERAPIES PORTFOLIO

Mechanical

Complete portfolio based on surgeon preference and patient needs

Standard AP360 Aortic valve graft

Aortic and mitral Aortic and mitral Aortic only

Intra-annular valve with Supra-annular flanged Intra-annular aortic graft

generous, compliant cuff for cuff configuration for
exceptional implantability improved flexibility,
needle penetration, and
conformability
SURGICAL VALVES THERAPIES PORTFOLIO

Repair

Mitral repair
Flexible Semi-rigid Rigid

SimuPlus™ Ring and Band SimuForm™ Ring
• Flexible, annular support with full • Combination of anterior
annular motion flexibility and posterior
• Braided polyester structure semi-rigidity
resists stretching and minimizes • Accommodates annular motion,
crimping provides posterior support
• Easy needle passage • Changes shape throughout the
and sutureability cardiac cycle, from the systolic
saddle to the flatter diastolic “O”
CG Future™ Band
• Shape/height provides
aggressive posterior elevation
• Eyelet stiffener structure
facilitates secure trigonal
anchoring
• Retains natural anterior motion,
especially during systole
Profile 3D™ Ring
• Rigidity restores the natural posterior
and anterior dimensions with a
saddle shape
• An asymmetric saddle shape reduces
leaflet stress. Minimum peak leaflet
stress occurs at an annular height to
commissural width ratio (AHCWR) of
15% to 25%1

Tricuspid repair
Semi-rigid Rigid
Tri-Ad™ 2.0 Band Contour 3D™ Ring
• Flexible and wide-open ends avoid conductive • Anatomically designed based on scans of healthy
tissue while accommodating annular motion tricuspid annuli
• Targeted, free wall, semi-rigid support provides • Addresses annular dilatation with extra septal lateral
annular remodeling where it is most needed compression and 3D annular remodeling
• Open design avoids interference with AV node

Doll N, Sheytanov V, Labrousse L, et al. Clinical performance of a three-dimensional saddle-shaped, rigid ring for mitral valve repair. Eur J Cardiothorac Surg. February 1, 2019;55(2):217-223.
1
SURGICAL VALVES THERAPIES PORTFOLIO

Avalus Bioiprothesis

INDICATIONS: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Contraindications:
None known.

WARNINGS/PRECAUTIONS/ADVERSE EVENTS: Only physicians who have received proper training in valve replacement should use this device. Accelerated structural
deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic
renal failure, or hyperparathyroidism). Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage,
infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural valve dysfunction (leaflet entrapment/impingement, obstructive
pannus ingrowth, suture dehiscence, inappropriate sizing or positioning, or other), pericardial effusion or tamponade, prosthesis regurgitation, prosthesis stenosis,
prosthesis thrombosis, stroke, structural valve deterioration (calcification, leaflet tear or perforation, or other), thromboembolism, tissue dehiscence, and transient
ischemic attack. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death.

MOSAIC BIOPROSTHESIS INDICATIONS: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Contraindications: None known.
Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and
patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias,
death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke,
structural deterioration, thromboembolism, or valve thrombosis.

HANCOCK II BIOPROSTHESIS INDICATIONS: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Contraindications: None
known. Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young
adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: angina, cardiac arrhythmia, cardiac
dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural
dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.

FREESTYLE BIOPROSTHESIS INDICATIONS: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement.
Contraindications: None known. Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children,
adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: cardiac
dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve
thrombosis, or intracuspal hematoma.
SURGICAL VALVES THERAPIES PORTFOLIO

SIMUFORM SEMI-RIGID ANNULOPLASTY RING 

INDICATIONS: The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged mitral valves. The SimuForm semi-
rigid annuloplasty ring provides support for the mitral annulus and restricts expansion of the annulus. Contraindications: Severe, generalized, or localized bacterial
endocarditis, heavily calcified valves, greatly dilated annulus (not reducible by standard techniques), severe valvular dysfunction (not correctable by standard techniques),
valvular retraction with severely reduced mobility, congenital malformations with lack of valvular tissue. Warnings/Precautions/Adverse Events: Only surgeons who have
received appropriate training in valve repair, including ring implant and sizing techniques, should use this device. Adverse events can include: uncorrected or recurrent
regurgitation, stenosis, ring dehiscence, hemolysis (even with mild regurgitation), low cardiac output, heart block, systolic anterior motion (SAM) and left ventricular
outflow tract obstruction (LVOTO), damage to coronary arteries, endocarditis, thrombosis, thromboembolism, anticoagulant-related hemorrhage, ring fracture, leaflet
perforation, bleeding diathesis.

SIMUPLUS FLEXIBLE ANNULOPLASTY RING AND BAND

INDICATIONS: The SimuPlus flexible annuloplasty ring and band are indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The band is
indicated for the same use for tricuspid valves. The SimuPlus flexible annuloplasty ring and band provide support for the mitral annulus or tricuspid annulus (band only)
and restrict expansion of the annulus. Contraindications: Severe, generalized, or localized bacterial endocarditis, heavily calcified valves, greatly dilated annulus (not
reducible by standard techniques), severe valvular dysfunction (not correctable by standard techniques), valvular retraction with severely reduced mobility, congenital
malformations with lack of valvular tissue. Warnings/Precautions/Adverse Events: Only surgeons who have received appropriate training in valve repair, including ring
implant and sizing techniques, should use this device. Adverse events can include: uncorrected or recurrent regurgitation, stenosis, ring or band dehiscence, hemolysis
(even with mild regurgitation), low cardiac output, heart block, systolic anterior motion (SAM) and left ventricular outflow tract obstruction (LVOTO), damage to coronary
arteries, endocarditis, thrombosis, thromboembolism, anticoagulant-related hemorrhage, ring or band fracture, leaflet perforation, bleeding diathesis.

CG FUTURE ANNULOPLASTY RING AND BAND

INDICATIONS: The CG Future annuloplasty ring and the CG Future annuloplasty band are indicated for the reconstruction and/or remodeling of pathological mitral
valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling. Contraindications: Heavily calcified valves, valvular
retraction with severely reduced mobility, active bacterial endocarditis. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve
repair should use this device. Adverse events can include: thromboembolism, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic
anterior motion, left ventricular outflow tract obstruction, anticoagulant-related hemorrhage, low cardiac output, damage to coronary arteries or sinus, thrombosis, ring or
band fracture, or leaflet perforation.

PROFILE 3D ANNULOPLASTY RING

INDICATIONS: This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by
appropriate repair and annular remodeling. Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.
Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include:
thromoboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract
obstruction, anticoagulant-related bleeding or hemorrhage.

TRI-AD 2.0 ADAMS TRICUSPID ANNULOPLASTY BAND

INDICATIONS: The Tri-Ad 2.0 Adams tricuspid band is indicated for the reconstruction or remodeling of pathological tricuspid valves. The band provides support for
and restricts expansion of the tricuspid annulus. Contraindications: Severe, generalized, or localized bacterial endocarditis; heavily calcified valves; greatly dilated
annulus (not reducible by standard techniques); severe valvular dysfunction (not correctable by standard techniques); valvular retraction with severely reduced mobility;
congenital malformations with lack of valvular tissue. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should
use this device. Adverse events can include: uncorrected or recurrent regurgitation, stenosis, band dehiscence, hemolysis (even with mild regurgitation), low cardiac
output, heart block, damage to coronary arteries, endocarditis, thrombosis, thromboembolism, anticoagulant-related hemorrhage, band fracture, leaflet perforation, and
bleeding diathesis.
SURGICAL VALVES THERAPIES PORTFOLIO

CONTOUR 3D ANNULOPLASTY RING

INDICATIONS: The Contour 3D ring is indicated for the reconstruction and/or remodeling of pathological tricuspid valves. Contraindications: Heavily calcified valves,
valvular retraction with severely reduced mobility, active bacterial endocarditis. Warnings/Precautions/Adverse Events: Only physicians who have received proper
training in valve repair should use this device. Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block,
endocarditis, right ventricular outflow tract obstruction, anticoagulant-related bleeding, or hemorrhage.

MEDTRONIC OPEN PIVOT HEART VALVE

INDICATIONS: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral
valves. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Warning: Persons allergic to
cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. Adverse events potentially associated with the use of prosthetic heart
valves include: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment
(impingement), transvalvular regurgitation, structural dysfunction, pannus, perivalvular leak, transvalvular leak, thrombosis, stroke, thromboembolism. It is possible that
these complications could lead to: reoperation, explantation, permanent disability, heart failure, death.

MEDTRONIC OPEN PIVOT AORTIC VALVED GRAFT (AVG)

INDICATIONS: The Medtronic Open Pivot Aortic Valved Graft (AVG) is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic
aortic valves, where a replacement valve and replacement or repair of the aorta is required. Contraindications: The AVG is contraindicated in patients unable to tolerate
anticoagulation therapy. The Hemashield® Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. Warning: The graft should not
be implanted in patients with a known sensitivity to products of bovine origin. Potential Adverse Events: Certain complications may occur with heart valve procedures.
Adverse events potentially associated with the use of prosthetic aortic heart valves include, but are not limited to: angina, cardiac arrhythmia, endocarditis, hemolysis,
hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak,
transvalvular regurgitation, structural dysfunction, thrombosis, stroke, thromboembolism. Adverse events potentially associated with the use of vascular grafts include,
but are not limited to: aneurysm; clinical reaction to collagen (shown to be a weak immunogen) described as infrequent, mild, localized, and self limiting; embolism;
hemorrhage; infection; occlusion (including thrombosis and anastomotic intimal hyperplasia); pseudoaneurysm; seroma. It is possible that these complications could
lead to: reoperation, explantation, permanent disability, heart failure, death.

CAUTION: Federal law (USA) restricts these devices to sale by or on the order of a physician.

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. For countries that use eIFUs,
consult instructions for use at medtronic.com/manuals.

NOTE: Manuals can be viewed using a current version of any major internet browser.
Appendix
PERIGON TRIAL

PERIGON hemodynamic outcomes

Mean aortic pressure gradient and valve efficient orifice area by visit and valve size
Valve size
Visit 17 mm 19 mm 21 mm 23 mm 25 mm 27 mm 29 mm All sizes
Mean aortic pressure gradient, mm Hg (n)
46.8 ± 23.5 44.4 ± 15.1 43.7 ± 14.7 40.1 ± 17.7 38.7 ± 18.5 30.8 ± 14.3 42.3 ± 16.7
Baseline NA
(37) (155) (305) (260) (77) (9) (837)
Discharge up to 14.0 18.6 ± 6.2 15.4 ± 5.1 13.0 ± 4.5 12.8 ± 4.0 10.7 ± 4.0 9.8 ± 3.9 13.4 ± 4.8
30 days (1) (37) (153) (302) (257) (73) (9) (789)
24.0 17.1 ± 5.0 14.5 ± 4.3 12.1 ± 3.8 11.7 ± 4.0 10.3 ± 4.2 9.8 ± 3.1 12.5 ± 4.4
1 year
(1) (27) (106) (205) (170) (43) (5) (557)
Effective orifice area, cm2 (n)
0.70 ± 0.20 0.77 ± 0.32 0.81 ± 0.36 0.98 ± 0.58 1.13 ± 0.80 1.37 ± 1.13 0.88 ± 0.50
Baseline NA
(34) (140) (290) (232) (71) (9) (775)
Discharge up to 1.40 1.22 ± 0.24 1.35 ± 0.28 1.56 ± 0.32 1.64 ± 0.34 1.85 ± 0.44 2.03 ± 0.40 1.56 ± 0.37
30 days (1) (30) (137) (257) (228) (65) (9) (727)
0.62 1.11 ± 0.25 1.25 ± 0.25 1.47 ± 0.32 1.57 ± 0.31 1.77 ± 0.41 2.01 ± 0.23 1.47 ± 0.35
1 year
(1) (25) (99) (201) (167) (41) (5) (539)
Effective orifice area index, cm2/m2 (n)
0.40 ± 0.11 0.42 ± 0.16 0.41 ± 0.18 0.48 ± 0.29 0.53 ± 0.39 0.66 ± 0.58 0.45 ± 0.25
Baseline NA
(34) (140) (290) (232) (71) (8) (775)
Discharge up to 0.98 0.69 ± 0.15 0.75 ± 0.18 0.80 ± 0.19 0.80 ± 0.17 0.87 ± 0.24 0.95 ± 0.20 0.79 ± 0.19
30 days (1) (30) (137) (257) (228) (65) (9) (727)
0.43 0.64 ± 0.14 0.69 ± 0.15 0.75 ± 0.17 0.77 ± 0.16 0.83 ± 0.18 0.97 ± 0.08 0.75 ± 0.17
1 year
(1) (25) (99) (201) (167) (41) (5) (539)

These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies.
PERIGON TRIAL

PERIGON hemodynamic outcomes

Mean aortic pressure gradient and valve efficient orifice area by visit and valve size, cont’d.
Valve size
Visit 17 mm 19 mm 21 mm 23 mm 25 mm 27 mm 29 mm All sizes
PPM, % (n/N)
Discharge up to 30 days
100 16.7 24.8 37.4 35.1 41.5 77.8 34.4
None
(1/1) (5/30) (34/137) (96/257) (80/228) (27/65) (7/9) (250/727)
0.0 40.0 43.1 40.9 47.4 47.7 22.2 43.6
Moderate
(0/1) (12/30) (59/137) (105/257) (108/228) (31/65) (2/9) (317/727)
0.0 43.3 32.1 21.8 17.5 10.8 0.0 22.0
Severe
(0/1) (13/30) (44/137) (56/257) (40/228) (7/65) (0/9) (160/727)
1 year
0.0 8.0 18.2 22.9 26.9 39.0 100.0 24.5
None
(0/1) (2/25) (18/99) (46/201) (45/167) (16/41) (5/5) (132/539)
0.0 36.0 33.3 50.7 50.3 48.8 0.0 46.0
Moderate
(0/1) (9/25) (33/99) (102/201) (84/167) (20/41) (5/5) (248/539)
100 56.0 48.5 26.4 22.8 12.2 0.0 29.5
Severe
(1/1) (14/25) (48/99) (53/201) (38/167) (5/41) (5/5) (159/539)

PPM definitions: none, EOAI > 0.85 cm2/m2; moderate, 0.65 < EOAI ≤ 0.85 cm2/m2; and severe, EOAI ≤ 0.65 cm2/m2. NA, Not available; PPM, prosthesis–patient mismatch.
These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies.
COMMENCE TRIAL

COMMENCE hemodynamic outcomes

Effective orifice areas and mean pressure gradients (echo core lab data)
Valve size
Visit 19 mm 21 mm 23 mm 25 mm 27 mm 29 mm Total
Effective orifice area (cm2)
21: 1.2 ± 0.3 120: 1.5 ± 0.5 191: 1.7 ± 0.4 183: 2.0 ± 0.6 88: 2.4 ± 0.7 19: 2.6 ± 0.6 622: 1.9 ± 0.6
Discharge (0.5, 1.7) (0.6, 3.7) (0.8, 3.7) (0.9, 4.3) (1.2, 4.8) (1.7, 4.0) (0.5, 4.8)
(1.1, 1.3) (1.4, 1.6) (1.7, 1.8) (1.9, 2.1) (2.2, 2.5) (2.3, 2.9) (1.8, 1.9)
22: 1.4 ± 0.4 117: 1.5 ± 0.4 196: 1.7 ± 0.4 184: 1.8 ± 0.5 90: 23 ± 0.7 11: 2.5 ± 0.8 620: 1.8 ± 0.6
3 months (0.6, 2.3) (0.8, 3.1) (0.9, 3.2) (0.7, 3.1) (0.9, 5.5) (1.5, 4.0) (0.6, 5.5)
(1.2, 1.6) (1.4, 1.5) (1.6, 1.8) (1.8, 1.9) (2.2, 2.5) (2.0, 3.0) (1.7, 1.8)
16: 1.1 ± 0.2 97: 1.3 ± 0.3 155: 1.6 ± 0.4 131: 1.8 ± 0.5 68: 2.2 ± 06 467: 1.7 ± 0.5
1 year (0.7, 1.4) (0.7, 2.4) (0.8, 2.9) (1.0, 3.3) (1.2, 3.7) (0.7, 3.7)
(1.0, 1.2) (1.3, 1.4) (1.5, 1.6) (1.7, 1.8) (2.1, 2.4) (1.6, 1.7)
8: 1.0 ± 0.4 42: 1.3 ± 0.3 64: 1.6 ± 0.4 48: 1.9 ± 0.5 17: 1.8 ± 0.5 179: 1.6 ± 0.5
2 years (0.6, 1.6) (0.9, 1.9) (0.8, 3.0) (1.1, 3.2) (1.1, 3.0) (0.6, 3.2)
(0.7, 1.3) (1.3, 1.4) (1.4, 1.7) (1.7, 2.0) (1.6, 2.1) (1.5, 1.7)
Mean gradient (mm Hg)
22: 17.9 ± 6.2 126: 13.1 ± 5.8 196: 10.8 ± 4.2 191: 9.9 ± 4.4 95: 8.4 ± 2.8 20: 6.0 ± 2.3 650: 10.7 ± 5.0
Discharge (8.8, 32.2) (1.5, 44.9) (2.4, 27.5) (1.7, 36.2) (2.8, 19.5) (1.5, 11.1) (1.5, 44.9)
(15.1, 20.7) (12.1, 14.2) (10.2, 11.4) (9.3, 10.5) (7.9, 9.0) (4.9, 7.1) (10.4, 11.1)
22: 13.8 ± 6.1 118: 10.7 ± 4.2 196: 9.4 ± 3.8 185: 8.7 ± 3.4 90: 6.8 ± 2.6 12: 4.7 ± 1.3 623: 9.1 ± 4.0
3 months (6.5, 29.6) (3.3, 27.3) (3.2, 27.9) (2.0, 23.6) (2.8, 19.6) (1.2, 6.2) (1.2, 29.6)
(11.1, 16.5) (9.9, 11.5) (8.8, 9.9) (8.2, 9.2) (6.3, 7.4) (3.8, 5.5) (8.8, 9.4)
16: 17.6 ± 7.8 97: 12.6 ± 4.7 158: 10.1 ± 3.8 132: 9.6 ± 5.2 69: 8.2 ± 3.5 472: 10.4 ± 4.9
1 year (7.4, 32.1) (4.5, 24.5) (1.7, 21.0) (22, 52.3) (2.9, 18.9) (1.7, 52.3)
(13.4, 21.7) (11.6, 13.5) (9.5,10.6) (8.7, 10.5) (7.4, 9.1) (10.0, 10.9)
8: 16.1 ± 6.4 42: 11.2 ± 4.0 66: 9.9 ±4.4 49: 9.2 ± 3.4 17: 8.3 ± 3.5 182: 10.1 ± 4.3
2 years (9.4, 23.8) (3.0, 21.2) (4.0, 22.8) (4.4, 17.1) (4.3, 16.8) (3.0, 23.8)
(10.8, 21.5) (9.9, 12.4) (8.8,11.0) (8.2, 10.2) (6.5, 10.1) (9.5, 10.7)

PPM definitions: none, EOAI >0.85 cm2/m2; moderate, 0.65 < EOAI ≤0.85 cm2/m2; and severe, EOAI ≤0.65 cm2/m2. NA, Not available; PPM, prosthesis–patient mismatch.
These charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to
clinical study outcomes and need to be considered in making any assessments across different studies.
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