Maximise

Clinical Safety*:
An approach to secure and
easy closure.

1
 Vascular complications have been declining, but are still some of
the most significant seen during a catheterization.

The Declining Rate of Vascular

Complictions
4
3.37 P < 0.001 for temporal trend
Major Complications:
3.5 3.2
• Hematoma
3
2.51 • Pseudoaneurysm
2.5 2.11 1.96 • ArteriovenousFistula
2
1.5
• Vessel Thrombosis/Occlusion
1
• Infection
0.5 • Retroperitoneal Bleed
0 • Transfusion
2002 2003 2004 2005 2006

Between 2002 and 2006, major vascular complications have decreased amon
patients undergoing percutaneous coronary intervention (PCI) in the Northern
New England Cardiovascular Disease Study Group. *Arterial injury and/or
arterial injury-related bleeding (n=36,631 patients undergoing PCI).

2 Dauerman et al, JACC Vol. 50, Oct 2007; pp 1617-26.

 Technologies and Design Concept

• Simplicity: Designed to reduce

number of components and
deployment steps
• Visual versus tactile feedback:
Improve patient comfort during
deployment
• Nitinol: Utilize Nitinol’s super-elasticity • Extravascular Placement:
and shape memory Designed to reduce the risk of
embolization, infection, and
other major adverse events
• Sheath Compatibility: No
sheath exchange**
• Polyglycolic Acid: Trusted plug
material, designed to close the
femoral artery puncture site
while causing low reactivity to
minimize access site
complications

3 **Compatible with sheaths up to 12 cm. Please consult IFU for further details.
 Ease of Use:Use With Existing Procedural Sheath

Insert the ExoSeal™ Device into the sheath and advance to the
level of the black marker band.

4
 Bleed-back Indicator

Retract the sheath back to the wire cowling -check for pulsatile
blood flow from the bleed-back indicator.

5
 Deployment of Indicator Wire

Continue to retract the sheath, compressing the green wire cowling

against the white handle. The sheath is now secured to the
ExoSeal™ Device and the indicator wire has deployed internally.

6
 Watch for First Visual Indicator

Pull the sheath and the ExoSeal™ Device back (retract with left
hand, maintain angle with right) –watch bleed-back indicator for
reduced, non-pulsatileflow.

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 Watch for Second Visual Indicator

When flow from the bleed-back indicator slows, watch for indicator
window to change to all black. Depress the plug deployment button.

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 Clinical Advantage: Extravascular Placement

Remove the ExoSeal™ Device and sheath.

Hold light fingertip pressure at the puncture site for two minutes.

9
 Deployment Positions

BLACK – WHITE BLACK – BLACK BLACK – RED

Device not yet positioned
to deploy
Lockout feature activated
Deploy, if significantly reduced
bleed-back is also seen from
bleed-back indicator
Release slight tension on
device until window shows
Black-Black.
Otherwise switch to manual
compression.

Proper deployment depends on visual indicators. No physical

tension change will occur to signify deployment.

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 Key Device Characteristics

• Clinically SAFE*: Extravascular Plug Placement

• No inflammation risk compared to intravascular devices
• Lock-out feature prevents deployment inside of artery

• Clinically SAFE*: Bioabsorbable Plug

• Utilizes non-collagen plug material, well known and trusted suture material
• Plug material is fully resorbed within 60-90 days  nothing stays behind
• Reabsorbs as carbon dioxide and water –no inflammation

• Clinically SAFE*: Easy to Use

• Deployed through existing procedural sheath
• Few steps and fast to deploy  low operator related risk
• Short learning curve for the user  less safety risks

EXOSEAL™ Vascular Closure Device BSI Design Dossier Clinical Performance Report, June 25, 2007
11 * Clinical data from the “ECLIPSE trial‘ indicates safety in terms of vascular injury, access-site related
bleeding, infection or nerve injury, new ipsilaterallower extremity ischemia or SAE.
 ECLIPSE Trial:
Ensure’s Vascular Closure
Device Speeds Hemostasis

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 ECLIPSE Trial
ECLIPSE Trial Design

• The safety and effectiveness of the 7F ExoSeal™ device was

assessed in two prospective, non-randomized studies conducted in
Mexico and Germany

• A prospective, multicenter, pivotal study was also conducted in the

U.S. comparing the 6F ExoSeal™ and manual compression (MC)
with 2:1 randomization in patients undergoing diagnostic and
interventional coronary/peripheral procedures

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 ECLIPSE Trial
Principal Investigators

• Mexico
• Jorge Luna Guerra, M.D. Hospital Almater Mexicali, Mexico

• Germany
• Marcus Wiemer, M.D. Herzzentrum Bad Oeynhausen – Universtität Bochum
Germany

• United States
• S. Chiu Wong, M.D. New York Presbyterian Hosp.- Cornell Campus New York
City, NY, USA

EXOSEAL™ Vascular Closure Device BSI Design Dossier Clinical Performance Report, June 25, 2007
14 * Clinical data from the “ECLIPSE trial‘ indicates safety in terms of vascular injury, access-site related
bleeding, infection or nerve injury, new ipsilaterallower extremity ischemia or SAE.
 ECLIPSE Trial
Objectives

• Two primary effectiveness endpoints to be tested for

superiority:
• Time to hemostasis (TTH)
• Time to ambulation (TTA)

• Primary safety endpoint to be tested for non-inferiority:

• 30-day combined rate of access site related complications including bleeding,
infection, ischemia or injury requiring medical or surgical treatment

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 ECLIPSE Trial
Patient Enrollment

EXOSEAL® 6F
EXOSEAL® 7F VCD
VCD
(17 U.S. Sites)
N=88
N=488

Mexico (10%)Germany Roll-in Randomized

(Single-Center) (6 Centers) N=87 N=401
N=30 N=60

Manual
EXOSEAL®
Compression
N=267
N=134

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 ECLIPSE Trial
Primary Effectiveness Endpoints

7F EXOSEAL® 6F EXOSEAL® MC
Roll-in 6 Fr P-value
(N=88) (N=267) (N=134)

Procedure Success 94.3% 95.4% 91.8% 91% 0.8500

Device Success 93.2% 95.4% 89.1% - -

TTH (min.) 3.25±4.25 4.68±19.4 4.38±11.6 20.05±22.5 <0.0001

TTA (hr.) 2.64±5.43 1.98±2.59 2.54±5.02 6.24±13.34 0.0028

TT Eligibility for Hospital

12.54±23.85 9.72±14.2 12.57±13.9 16.26±27.5 0.1540
Discharge (hr.)
TT Hospital Discharge
33.22±45.90 13.64±18.5 16.77±19.8 19.35±29.2 0.3612
(hr.)
TT Device Deployment
0.62±0.25 0.94±1.13 1.01±2.12 - -
(min.)

17 P-values are based on comparison of the two randomized cohorts (6F ExoSeal ® compared to MC)
 ECLIPSE Trial
Primary 30-Day Safety Endpoints
7F EXOSEAL® 6F EXOSEAL® MC
Roll-in 6 Fr
(N=88) (N=267) (N=134)
Composite Major Adverse
0.0% 0.0% 0.0% 0.0%
Event
Vascular Repair 0.0% 0.0% 0.0% 0.0%
Access Site Related
Bleeding Requiring 0.0% 0.0% 0.0% 0.0%
Transfusion
Access Site Related Infection
0.0% 0.0% 0.0% 0.0%
Requiring Treatment
Any New Documented
Ipsilateral Lower Extremity 0.0% 0.0% 0.0% 0.0%
Ischemia
Surgery for Access Site-
0.0% 0.0% 0.0% 0.0%
Related Nerve Injury

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 ECLIPSE Trial
Secondary 30-Day Safety Endpoints
7F EXOSEAL® 6F EXOSEAL® MC
Roll-in
(N=88) (N=267) (N=134)
Rebleeding following initial
0.0% (0) 3.4% (3) 5.2% (14) 2.2% (3)
hemostasis
Access site hematoma 6
3.4% (3) 3.4% (3) 2.2% (6) 0.7% (1)
cm
Site-related bleeding req. >30
0.0% (0) 1.1% (1) 0.4% (1) 0.7% (1)
min. for hemostasis
Treated, localized access site
0.0% (0) 0.0% (0) 0.0% (0) 0.0% (0)
infection

Retroperitoneal bleeding 0.0% (0) 0.0% (0) 0.7% (2) 0.0% (0)

Decrease in pedal pulse 0.0% (0) 1.1% (1) 0.0% (0) 0.0% (0)

There were NO incidence of pseudoaneurysm not requiring treatment; treated pseudoaneurysm; documented AV
fistula; post-hospital discharge access site related bleeding; ipsilateral lower extremity arterial emboli; transient loss of
ipsilateral lower extremity pulse; ipsilateral DVT; access site related vessel laceration; access site wound dehiscence;
treated, localized access site infection; ipsilateral peripheral artery total occlusion; intraluminal plug delivery not
requiring surgical intervention; or death in any cohort. There was no statistically significant difference in the two
randomized cohorts (6F EXOSEAL® vs. MC)

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 For Healthcare Professionals Only.
© 2017 Cardinal Health. All Rights Reserved.
CORDIS, Cordis LOGO, and EXOSEAL are trademarks or registered trademarks of Cardinal Health.
Important Information:
Prior to use, refer to the “Instructions for Use” supplied with these devices for indications, contraindications, side
effects, suggested procedure, warnings, and precautions.
EU2158 03/17

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