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Mitral valve regurgitation and treatment

Understanding and repairing your leaky heart valve

Mother and daughter walking along beach
Mother and daughter walking along beach
Mother and daughter walking along beach

There’s life after transcatheter mitral valve repair

Degenerative mitral valve regurgitation (DMR), sometimes called primary mitral valve regurgitation (PMR), is a serious condition. But there’s a less invasive treatment option that can repair your leaky heart valve.1

healthy heart
healthy heart
healthy heart
leaking mitral valve
leaking mitral valve
leaking mitral valve

What is degenerative mitral regurgitation?

Degenerative mitral regurgitation is when the leaflets of the heart’s mitral valve do not close properly. This causes blood to leak backward, making it difficult for your heart to move blood through to the rest of your body efficiently. It may make you feel tired or out of breath, and it may cause an overall decrease in your quality of life.

Why treat a leaky heart valve?

Treating mitral regurgitation is key to maintaining your heart health and could make a difference for your quality of life.2

By treating mitral regurgitation, you can potentially:

Walking icon
Walking icon
Walking icon

Improve your quality of life

with improved ability to do physical activities1

Downward chart icon
Downward chart icon
Downward chart icon

Safely reduce MR

with a procedure shown to have a low risk of complication1

Heartbeat icon
Heartbeat icon
Heartbeat icon

Improve your symptoms

including shortness of breath, fatigue, irregular heartbeat and swelling1

Gardening Couple
Gardening Couple
Gardening Couple

A less invasive
treatment option

Gardening Couple
Gardening Couple
Gardening Couple

If you have mitral regurgitation and your doctor has evaluated you as prohibitive risk for open heart surgery, transcatheter valve repair may be an option for you. Only a specialized heart team can determine which treatment option is appropriate for you.

Larry’s PASCAL system story

I was thinking to myself, I can breathe again. I can do what I want to do again.




  1. 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. JACC Cardiovasc Interv. 2022 Dec 26;15:2523-2536. Epub 2022 Sep 17.
  2. El Sabbagh A, Reddy YNV, Nishimura RA. Mitral valve regurgitation in the contemporary era: insights into diagnosis, management, and future directions. JACC Cardiovasc Imaging. 2018;11:628-643.

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


  • 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 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.

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