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Mitral and tricuspid valve repair

Transcatheter intervention to treat your mitral or tricuspid regurgitation

Woman wearing yellow shirt consulting with doctor
Woman wearing yellow shirt consulting with doctor
Woman wearing yellow shirt consulting with doctor

What is transcatheter valve repair?

Pascal Anatomy Diagram
Pascal Anatomy Diagram
Pascal Anatomy Diagram

Transcatheter mitral valve repair (TMVr) and transcatheter tricuspid valve repair (TTVr) are catheter-based procedures to repair mitral and tricuspid valves.

Unlike traditional heart surgery, in which the surgeon cuts through the chest wall and then the heart to access the valve, TMVr and TTVr involve implanting a device through a small incision in your upper thigh, near the groin, using a flexible tube called a catheter.

Pascal Anatomy Diagram
Pascal Anatomy Diagram
Pascal Anatomy Diagram
The PASCAL Implant
The PASCAL Implant
The PASCAL Implant

The PASCAL implant

The PASCAL Implant
The PASCAL Implant
The PASCAL Implant

The Edwards PASCAL Precision transcatheter valve repair system is designed to repair the tricuspid or mitral valve and reduce tricuspid or mitral valve regurgitation.1

The PASCAL and PASCAL Ace implants are made of nitinol (nickel and titanium) and have clasps that bring the leaflets of the mitral or tricuspid valve together. The PASCAL Ace is the smaller of the two implants. Your doctor will determine the best implant option for your valve.

What to expect from a transcatheter valve repair procedure

Repairing your mitral valve


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While you are under general anesthesia, your doctor will make a small cut in your upper thigh, near the groin, to access your femoral vein. They will then insert a tube-like device called a delivery catheter. The implant is attached to the tip of the delivery catheter.

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The implant will be guided to your mitral valve using imaging equipment.

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03 Icon
03 Icon

The implant will be positioned to clasp together your mitral leaflets to reduce the blood leak.

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After verifying the final position of the implant, your doctor will release it from the delivery system. The implant will stay in your heart.1

85%

Reduction in annual heart failure hospitalization rate with the PASCAL repair system*2

97%

of patients achieved moderate to no mitral regurgitation with the PASCAL repair system*2

*Results at two-year post-procedure follow-up

Repairing your tricuspid valve


1 icon
1 icon
1 icon

While you are under general anesthesia, your doctor will make a small cut in your upper thigh, near the groin, to access your femoral vein. They will then insert a tube-like device called a delivery catheter. The implant is attached to the tip of the delivery catheter.

2 icon
2 icon
2 icon

The implant will be guided to your tricuspid valve using imaging equipment.

03 Icon
03 Icon
03 Icon

The implant will be positioned to clasp together your tricuspid leaflets to reduce the blood leak.

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After verifying the final position of the implant, your doctor will release it from the delivery system. The implant will stay in your heart.1

86%

of patients achieved moderate to no tricuspid regurgitation with the PASCAL repair system*3

88%

Procedural success was achieved in 88% of patients with the PASCAL repair system**3

*Results at one-year post-procedure follow-up

**Procedural success: Implantation of at least one device with post-procedural TR of a moderate or less grade, with no device-related complication, mortality or conversion to surgery

Doctor consulting patient
Doctor consulting patient
Doctor consulting patient

A safe, effective
treatment option

Doctor consulting patient
Doctor consulting patient
Doctor consulting patient

The PASCAL repair system has been studied and shown to be safe and effective at repairing mitral and tricuspid valves in patients with significant regurgitation.1–3

After fixing your mitral or tricuspid valve, you may notice fewer symptoms, improved quality of life and increased ability to exercise.2–4

As with any implanted medical device, there are risks associated with this procedure. Talk to your doctor for a full explanation of the benefits and risks.1

Frequently asked questions

What can I expect from the procedure and recovery?

Learn more about the procedure and what to expect from transcatheter valve repair with the PASCAL Precision system.

Dr with tablet consulting with patient
Dr with tablet consulting with patient
Dr with tablet consulting with patient
Dr with tablet consulting with patient
Dr with tablet consulting with patient
Dr with tablet consulting with patient

Download resources

Get answers to your questions about mitral regurgitation, tricuspid regurgitation and treatment in these downloadable PDFs.

Brochures
Brochures
Brochures

References

  1. Edwards Lifesciences. Edwards PASCAL Precision Transcatheter Valve Repair System. Instructions for Use. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf22/P220003D.pdf [Accessed 27 April 2023].
  2. Szerlip M, et al. 2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study. JACC Cardiovasc Interv. 2021 Jul 26;14(14):1538-1548. Erratum in: JACC Cardiovasc Interv. 2022 Jul 11;15(13):1395.
  3. Kodali S, et al. 1-Year outcomes of transcatheter tricuspid valve repair. J Am Coll Cardiol. 2023 May 9;81(18):1766-1776. doi: 10.1016/j.jacc.2023.02.049.
  4. Kitamura M, et al. 12-Month outcomes of transcatheter tricuspid valve repair with the PASCAL system for severe tricuspid regurgitation. Catheter Cardiovasc Interv. 2021 May 1;97(6):1281-1289.

Medical device for professional use.

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).

Edwards, Edwards Lifesciences, the stylized E logo, CLASP, Edwards PASCAL, Edwards PASCAL Precision, PASCAL, and PASCAL Precision are trademarks or service marks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

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