FDA approves clipping leaking valves

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1700 S. Tamiami Trail Sarasota FL

Posted: Friday, December 20, 2013 3:21 pm | Updated: 10:23 am, Thu Jan 2, 2014.

  • SMH

Mitral regurgitation (MR) affects millions of people worldwide. It is the most common type of heart valve defect, affecting one in 10 people aged 75 and older. The condition occurs when the heart’s mitral valve does not close completely, causing blood to leak backward into the left atrium with every heartbeat.

Traditionally, there have been no good treatment options for people who are too frail or sick to undergo open heart surgery.

But now, a new minimally invasive treatment option is available for select patients with functional (or primary) MR. Because of its expertise in performing minimally invasive valve techniques and clinical research experience, Sarasota Memorial was designated one of 75 testing sites participating in the Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients (COAPT) trial in North America.

“We are very fortunate to be able to participate in this multi-center trial,” said Ricardo Yaryura, MD, medical director of Sarasota Memorial’s cardiology services, who serves as principal investigator, along with sub-investigator Michael Mumma, MD, of the COAPT trial at Sarasota Memorial. “It can be a life changing – potentially life saving – option for local patients suffering with severe mitral regurgitation,”

Mitral regurgitation requires the heart to work harder to maintain an adequate forward flow of blood, Dr. Yaryura said. Over time, that can lead to serious heart rhythm problems, stroke, heart attack, heart failure and death.

The COAPT trial is a randomized study that will enroll up to 420 patients. Because it is randomized, half the patients will be assigned to the device group that will receive the MitraClip (along with standard therapy) and half will be assigned to a control group that receives standard therapy alone. All of the study participants will remain in the trial for up to five years to determine if the MitraClip provides benefits over and above standard care alone.

The MitraClip is manufactured by Abbott Vascular. It is the world's first percutaneous mitral valve repair therapy available for select patients with MR. Clinical studies show that the MitraClip compares favorably with conventional open-heart surgery for treatment of select patients with mitral regurgitation. Although it is commercially available in more than 30 countries, it remains under review by the U.S. Food and Drug Administration (FDA); it was recently approved for use in high risk patients with degenerative (secondary) MR; patients with functional MR must be enrolled in the clinical trial to be eligible to receive the device in the United States.

Clinical Research Trial Contact Information:

Kathy Pope-Nix, BSN, MBA

Clinical Research Coordinator

Sarasota Memorial Health Care System

(941) 917-1669

Email: Kathy-pope-nix@smh.com

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