NOVEL MEDICAL

DEVICES APPROVED BY
FDA AND RECENT
PATENTED MEDICAL
DEVICES

B Y - NAMAN KOTHARI
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INTRODUCTION
The products listed in this section include some of the newest
medical technology from the year 2023 And 2024. The
products in each list contain information about what medical
uses the device is cleared or approved for, when it can be used,
and when it should not be used. This information, along with
information from doctor and other sources, can help make you
an informed participant in your health care.
 2024
Device Name Category Date

Edwards EVOQUE Tricuspid Valve Replace Tricuspid Valve Replacement System 02/01/2024
ment System – P230013

2023
Device Name Category Date

RHA 3 dermal filler - P170002/S030 Dermal Filler 10/27/20

23

Aurora EV-ICD System - P220012 Heart Monitor 10/20/20

23

OncomineTM Dx Target Test - P160045/S025 Lab Test 09/29/20

23

CRCdx(R) RAS Mutation Detection Kit - P220005 Lab Test 09/29/20

23

Belotero Balance ® (+) - P090016/S050 Dermal Filler 09/27/20

23

LimFlowTM System Stent 09/11/20

23

Click to add picture

Boston Scientific Cardiac Cryoablation System and Accessories, consisting of: POLARx Catheter 08/08/2023
Cryoablation Ballon Catheter, POLARx
FIT Cryoablation Ballon Catheter, SMARTFREEZE Cryoablation System Console - P220032

Minitouch 3.8 Era System - P230002 Endometrial 07/28/2023

PALMAZ MULLINS XD Pulmonary Stent - P220004 Stent 07/21/2023

CraniSeal Dural Sealant - P220014 Sutures Sealant 07/06/2023

Optilume BPH Catheter System - P220029 Prostatic Catheter 06/30/2023

AAV5 DetectCDx – P190033 Lab Test 06/29/2023

HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads – P200007 Defibrillator 06/23/2023

SurVeil Drug-Coated Ballon - P210025 Catheter 06/16/2023 Clic

TOPS System – P220002 Spinal Implant 06/15/2023

Inspire Upper Airway Stimulation - P130008/S090 Nerve Stimulator 06/08/2023

FoundationOne Liquid CDx (F1 Liquid CDx) - P190032/S010 Lab Test 06/08/2023

DETOUR System - P220021 Stent 06/07/2023

Perclose ProStyle Suture-Mediated Closure and Repair System and Perclose ProGlide Catheter Systems 06/02/2023
-Suture Closure Systems - P960043/S118

LiquiFix FIX8 Laparo Hernia Mesh Fixation Devices - P220024 Hernia Fixation 06/02/2023
PerClot Polysaccharide Hemostatic System - P210036 Hemostatic system 05/19/2023
Tactiflex Ablation Catheter, Sensor Enabled - P220013 Cardiac catheter 05/18/2023
VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) Cardiac Implants 05/17/2023
- P130010
REFLECT Scoliosis Correction System - H210002 Spinal Implant 05/15/2023
SKINVIVE by JUVÉDERM – P110033/S059 Dermal Filler 05/11/2023
Restylane Eyelight – P040024/S135 Dermal Filler 05/08/2023
FoundationOne Liquid CDx (F1 Liguid CDx) - P190032/S005 Lab Test 05/03/2023
xT CDx - P210011 Lab Test 04/28/2023
ADVIA Centaur HBc Total 2 (HBcT2), ADVIA Centaur HBc Total 2 Quality Control ( Lab Test 04/28/2023
HBcT2 QC), Atellica IM HBc Total 2 (HBcT2), Atellica IM HBc Total 2 Quality Cont
rol (HBcT2 QC) - P210019/S002

Precision7, Precision7 for Astigmatism, Precision7 Multifocal, Precision7 Multifocal Contact Lens 04/25/2023
Toric (serafilcon A) - P220007
Sculptra - P030050/S039 Gel Implant 04/25/2023
MiniMed 780G - P160017/S091 Glucose Monitor 04/21/2023
Lava Liquid Embolic System – P220020 Vascular Hemorrhage 04/04/2023
Blocker
Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, Hom Spinal Stimulator 03/31/2023
eStream Remote Management - P210037
NeuRx Diaphragm Pacing System - P200018 Breathing Stimulator 03/31/2023
Eversense E3 Continuous Glucose Monitoring (CGM) System - P160048/S021 Glucose Monitor 03/29/2023
iCAST Covered Stent System - P120003 Stent 03/22/2023
Inspire Upper Airway Stimulation - P130008/S089 Nerve Stimulator 6
03/20/2023

RelayPro Thoracic Stent-Graft System - P200045/S002 Stent 03/07/2023

CALCIVIS Imaging System - P170029 Syringe Applicator 03/07/2023

VENTANA PD-L1 (SP263) Assay - P160046/S013 Lab Test 03/01/2023

StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD) - P220009 Cataract surgery 02/22/2023

Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems - P010032/ Spinal Implant 02/15/2023
S189

Guardant360 CDx - P200010/S010 Lab Test 01/27/2023

 EDWARDS EVOQUE TRICUSPID
VALVE REPLACEMENT SYSTEM – 7

P230013
Product Name: Edwards EVOQUE Tricuspid Valve Replacement
System

PMA Applicant: Edwards Lifesciences LLC

Address: One Edwards Way, Irvine, CA 92614

Approval Date: February 01, 2024

What is it?
The Edwards EVOQUE Tricuspid Valve Replacement System mainly
includes an artificial tricuspid valve (called the EVOQUE valve) and a
delivery catheter. The EVOQUE valve is made of cow tissue attached to
a self-expanding metal (nickel-titanium) frame for support. It can be
used to replace the tricuspid valve of the heart without open-heart
surgery. The tricuspid valve prevents backflow of blood into the right
atrium (upper right chamber of the heart) from the right ventricle
(lower right chamber of the heart).
HOW DOES IT WORK
8

1. The doctor compresses the EVOQUE valve and places it on the end of the delivery
catheter. The doctor then inserts the catheter with the attached valve through the
largest vein (femoral vein) in the groin area and pushes it through the blood vessels
until it reaches the diseased tricuspid valve. The doctor then releases the valve
from the catheter. The valve will expand to anchor within the patient’s diseased
valve. Finally, the doctor removes the delivery catheter from the body. Once the
new valve is in place, it functions the same as the old valve, opening and closing
like a door to force the blood to flow in the correct direction within the heart.contact

How is it used
The EVOQUE valve is intended to treat patients with severely leaky
tricuspid valve (tricuspid regurgitation) often caused by an enlarged heart
or damaged native valve flaps (called leaflets).

What will it accomplish

 9
WHAT WILL IT ACCOMPLISH?
The EVOQUE valve could reduce the amount of blood that moves in the wrong
direction through the tricuspid valve. As a result, the patient may have:
•improved quality of life
•relief of symptoms such as tiredness or fatigue
•improved ability to exercise
A clinical study compared the results of 96 patients treated with the EVOQUE valve
and medicine, and 54 patients treated only with medicine. The study showed:
•About 28% (28 out of 100) patients treated with the EVOQUE valve experienced a
major safety complication (for example, death from heart-related cause, need for
permanent pacemaker, or severe bleeding) within 30 days of the procedure.
•About 99% (99 out of 100) of the patients treated with the EVOQUE valve had
their severe valve leakage reduced to moderate or less compared to about 22%
(22 out of 100) of the patients treated with medicine alone.
•Patients who received an EVOQUE valve were about five times more likely to have
an improved quality of life, fewer symptoms (for example, shortness of breath and
fatigue), and improved ability to exercise six months after the procedure, than
patients treated with medicine alone.
ONCOMINE™ DX TARGET TEST –
P160045/S025 10

Product Name: Oncomine™ Dx Target Test

PMA Applicant: Life Technologies Corporation
Address: 7335 Executive Way, Frederick, MD 21704
Approval Date: September 29, 2023
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• What is it?
• The Oncomine™ Dx Target Test is a laboratory test designed to detect genetic changes in tumor
tissue samples from a person with certain type of cancers. This approval expands the use of the test
to identify a certain mutation in anaplastic thyroid cancer. People whose anaplastic thyroid cancer
has a certain change (specifically BRAF V600E mutation), detected by the test may benefit from
personalized treatment with TAFINLAR® in combination with MEKINIST®.
• The test was previously approved to detect certain genetic changes in tissue samples from people
with non-small cell lung cancer, cholangiocarcinoma (bile duct cancer), thyroid cancer, and
medullary thyroid cancer.
• How does it work?
• The doctor takes a small amount of cancer tissue from a person’s tumor and sends it to a lab. The
lab embeds the cancer tissue into wax, which is later cut into thin slices. The lab uses a few slices to
isolate DNA and RNA, which are later mixed with chemicals called reagentsExternal
Link Disclaimer that detect and analyze specific DNA sequences of the BRAF gene to evaluate the
presence or absence of a mutation. The lab sends the results to the doctor who ordered the test. The
doctor uses this information to help manage treatment for a person with anaplastic thyroid cancer.
If the BRAF mutation is found in the cancer tissue sample, it indicates that this particular person is
eligible for treatment with TAFINLAR® in combination with MEKINIST ®.
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• When is it used?
• The test is used to evaluate tumors from people with anaplastic thyroid cancer. The results help
doctors decide if a person might be eligible for treatment with TAFINLAR® (dabrafenib) in
combination with MEKINIST (trametinib).
• What will it accomplish?
• The Oncomine™ Dx Target Test can help doctors decide whether people with anaplastic thyroid
cancer can receive treatment with TAFINLAR® (dabrafenib) in combination with MEKINIST
(trametinib) based on their test results.
BELOTERO BALANCE®

Product Name: Belotero Balance® (+)

PMA Applicant: Merz North America, Inc.
Address: 6501 Six Forks Road, Raleigh, NC
27615
Approval Date: September 27, 2023
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• What is it?
• Belotero Balance® (+) is a prescription gel implant or dermal filler that is injected to improve the appearance of
depressed, sunken, or hollow areas under the eyes. The depression under the eyes is called infraorbital hollowing.
Belotero Balance® (+) comes in a blister pack containing 1-mL of sterile gel prefilled in a glass syringe and packaged
with two sterile needles and two patient record labels.
• This approval expands the use of this product for infraorbital hollowing. It was previously approved for moderate to
severe facial wrinkles and folds.

• How does it work?

• Belotero Balance® (+) is injected by a doctor into the skin under the eyes, between the lower eyelid and the cheekbone.

• When is it used?
• This new approval allows Belotero Balance® (+) to be used as a filler intended to improve infraorbital hollowing in
people over the age of 21.

• What will it accomplish?

• Belotero Balance® (+) is intended to improve infraorbital hollowing. In a clinical study with 144 participants, people
needed one or two treatments with multiple injections to achieve the best outcome. The results may last up to 48
weeks.
MINITOUCH 3.8 ERA
SYSTEM – P230002

Product Name: Minitouch 3.8 Era System

(Minitouch System)
PMA Applicant: MicroCube, LLC
Address: 47853 Warm Springs Blvd,
Fremont, CA 94539
Approval Date: July 28, 2023
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• What is it?
• The Minitouch 3.8 Era System is a global endometrial ablation device used to treat heavy menstrual
bleeding. These types of devices use a cold or heat energy source to destroy (thermally ablate) the
lining of the uterus (endometrium) as a whole.
• How does it work?
• A health care provider inserts the hand piece of the Minitouch 3.8 Era System into the uterus. The
provider may need to dilate the cervix to allow insertion. After the handpiece is inserted into the
uterus, microwave energy produces heat that is delivered for a few minutes to destroy the uterine
lining. After energy delivery is completed, the hand piece is removed.
• When is it used?
• The Minitouch 3.8 Era System is intended for ablation of the endometrial lining of the uterus for the
treatment of menorrhagia (heavy menstrual bleeding) caused by non-malignant conditions (benign
causes) in pre-menopausal women who do not wish to become pregnant in the future.
• What will it accomplish?
• Eighty-nine-point five percent (89.5%) of people treated experienced a reduction in blood loss,
moving from an excessive level of bleeding to more typical or less than typical levels. Based on safety
outcomes from the clinical study, serious adverse events are expected to be rare.
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A CARDIAC DEVICE DEVELOPED BY A CITY-BASED DOCTOR HAS

RECEIVED PATENT RIGHTS FOR THE INVENTION, WHICH WILL SAVE
INFANTS BORN WITH CONGENITAL HEART DEFECTS.

• A cardiac device developed by a city-based doctor has received patent rights for the invention, which will save infants born
with congenital heart defects.

• HYDERABAD: A cardiac device developed by a city-based doctor has received patent rights for the invention, which will save
infants born with congenital heart defects.
Dubbed as 'KONAR-MF', the device designed by Dr Koneti Nageswara Rao, director of Rainbow Children's Heart Institute, has
received European EC approval in 2019, while Euro-African, Korean patents were granted in 2021 and 2022, respectively.

• After critical examinations, the Indian patent was granted in February 2023. "Now, the device is available commercially
through Lifetech Scientific co, Schengen. So far, the innovation has benefitted over 10,000 patients from across 72 countries,"
Nageswara Rao said.
The device is helpful for treating infants with ventricular septal defect (VSD) - a hole between two lower chambers
(ventricles) of the heart.
This is the common congenital heart defect among the children born with VSDs.
• if left untreated, children may develop complications like pneumonia, pulmonary hypertension and endocarditis, which may
lead to mortality. "Patients with heart failure have the option of open heart surgery for treatment. It works well only when
done in 3-6 months of age. The device prevents clamping force and stress. It cuts out chances of developing a heart block,"
said Dr Nageswara Rao.
The early results were presented in American college of cardiology meeting at Chicago, USA in 2012. The new occlude design
was developed later and the device has a narrow connector to avoid formation of a heart block during surgery. "Other
advantages like hemodynamic advantage and delivery screws on either side makes the operator to deploy easily from both
venous and arterial sides," he added.
THANK
YOU !!!!!!