Mitral valve repair

Transcatheter intervention treats your leaky mitral valve using a specially designed implant.

What is transcatheter mitral valve repair?

Transcatheter mitral valve repair (TMVr), sometimes referred to as transcatheter edge-to-edge repair (TEER), is a procedure to address backward leakage in your mitral valve to help blood flow properly.

If you have mitral regurgitation and your doctor has evaluated you as prohibitive risk for open heart surgery, transcatheter mitral valve repair may be an option for you. This treatment is less invasive than traditional open-heart surgery.

The procedure is performed through a small incision in the leg. Your doctor places a thin tube called a catheter through a delivery system into a large vein in your leg to reach your heart, and then implants a small device to repair the mitral valve.

The PASCAL Precision implant system

The PASCAL Precision implant system is designed to repair the mitral valve and help reduce mitral regurgitation.

Your doctor will guide a small implant to your mitral valve via a catheter-based delivery system through your femoral vein. The implant is secured to the leaflets of your mitral valve, and the central spacer acts as a filler to block backward blood flow.

The PASCAL Precision implant system has two implant sizes: the PASCAL and PASCAL Ace. Your doctor will select the best implant option for your anatomy.

Repairing your leaky valve

Read how the transcatheter mitral valve repair procedure works.

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Your doctor will make a small cut in your groin area to access the largest vein there.

Your doctor will then insert a tube-like device (delivery catheter) through the small cut and direct it to your mitral valve under imaging guidance. The PASCAL implant is attached to the tip of the delivery catheter.

Once the implant is properly positioned in your mitral valve, your doctor will grasp the two leaflets of your mitral valve and secure them together.

Lastly, your doctor will release the implant from the delivery catheter and remove the delivery catheter from your body.

A clinically proven treatment option

The PASCAL system has shown excellent safety and effectiveness in clinical studies.²

After fixing your leaky valve, you may notice fewer symptoms, improved quality of life and increased ability to exercise.² As with any implanted medical device, there are risks associated with this procedure. The most serious risks are death, stroke, serious bleeding, unplanned repeat procedure or surgery. Talk to your doctor for a full explanation of the benefits and risks.¹

98.3%

of patients avoided heart failure hospitalization with the PASCAL implant at 6 months^*2

98%

of patients achieved moderate to no MR with the PASCAL implant at 6 months^*2

Learn what the procedure is like

*Results at six-month post-procedure follow-up

Frequently asked questions

What is treatment like?

Learn more about what the transcatheter mitral valve repair procedure is like.

Get the details

Download the info guide

Get answers to your questions about mitral regurgitation and treatment in this downloadable PDF.

Download the guide

References

Edwards PASCAL Transcatheter Valve Repair System: Instructions for Use.
Lim DS, Smith RL, Gillam LD, Zahr F, Chadderdon S, Makkar R, et al. Randomized comparison of transcatheter edge-to-edge repair for degenerative mitral regurgitation in prohibitive surgical risk patients. J Am Coll Cardiol Intv. 2022;15:2523-36.

Important Risk Information

Edwards PASCAL Precision Transcatheter Valve Repair System

Who can be treated:

The PASCAL Precision transcatheter valve repair system (the PASCAL Precision system) is approved for treating patients with abnormality of the mitral valve leaflets and/or its structure, which may be referred to as Degenerative Mitral Regurgitation or Primary Mitral Regurgitation. Patients should work with their doctor and a specialized Heart Team, which should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, to confirm their surgical risk. The specialized Heart Team will determine if the patient is a suitable candidate for the PASCAL procedure.

Who should not use:

The PASCAL Precision system should not be used in patients who:

Cannot tolerate certain blood thinners during or after the procedure
Have an untreatable allergy to nickel, titanium or X-ray contrast media
Have an active infection of the mitral valve (endocarditis)
Have mitral regurgitation caused by rheumatic disease
Have evidence of blood clots in the heart or veins leading to the heart

Warnings:

Serious complications, sometimes leading to surgical intervention and/or death, may be associated with the use of this system. Talk to your doctor for a full explanation of the benefits and risks associated with this procedure.
As with any implanted medical device, there is potential for an adverse allergic or immunological response.
Careful and continuous medical follow-up is advised so that any complications can be diagnosed and properly managed.
Blood thinning medication will be determined by your doctor per standard guidelines.
The PASCAL Precision system has not been evaluated in pregnant women or children.

Precautions:

Precautions Prior to Use

Your heart team will do an assessment to decide if you are a suitable candidate for this procedure.

Precautions After Use

Follow all care instructions to ensure the best possible results. Regular follow-up is advised to evaluate the performance of your device.
Short-term blood thinning medication may be necessary after valve repair with the PASCAL Precision system. Your doctor should prescribe this and other medical therapy per standard guidelines.

Potential Risks

The most serious risks associated with the procedure are:

Death
Stroke
Serious bleeding
Unplanned repeat procedure or surgery

Additional potential risks include:

Abnormal heart rhythms or cardiac arrest, which may require a pacemaker
Abnormal low or high blood pressure
Allergic reaction to anesthetic, contrast, heparin, Nitinol (Nickel and Titanium) and/or other medications
Aneurysm or pseudoaneurysm
Bleeding, stomach bleeding, hemolysis, or decreased blood count, which may require transfusion
Blood clots in the legs (Deep Vein Thrombosis)
Blood clots, particles, catheter fragments or air in the blood vessels, lungs, body or brain
Cardiogenic shock
Chest pain
Damage or puncture of the heart or blood vessels that may require surgery
Damage, injury to, narrowing, or tearing of the mitral valve or other valve structures
Damage to the swallowing passage (esophagus), with possible puncture or narrowing
Dislodgement of a previous implant
Failure to retrieve any PASCAL Precision system components
Fever or infection, including of the heart valve
Fluid or blood around the heart or lungs
Heart attack
Implant deterioration (wear, tear, fracture or other), malposition, clotting, movement or embolization
Kidney failure
Lab values that are not normal
Nerve injury, paralysis or neurological symptoms, including problems with movement or walking
Organ failure, including heart failure
Pain
Respiratory compromise that may require prolonged need for a respirator
Shortness of breath, fainting or dizziness, nausea and/or vomiting, swelling, weakness, diminished exercise ability
Skin burn, injury or tissue changes due to exposure to X-rays
Single leaflet device attachment (SLDA)
Vascular injury or trauma, including decreased blood flow, dissection or occlusion
Worsening of valvular insufficiency
Wound healing infection or slow healing

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

Edwards, Edwards Lifesciences, the stylized E logo, Edwards PASCAL, Edwards PASCAL Ace, PASCAL, PASCAL Ace, PASCAL Precision, are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates.