MitraClip, courtesy of Abbott Vascular

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The U.S. Food and Drug Administration (FDA) has recently approved Abbott Vascular’s MitraClip heart valve repair device for heart failure patients with moderate-to-severe or severe mitral regurgitation (MR). This type of MR, commonly known as secondary or functional MR, is due to diminished function of the left heart. The device gained this approval after being originally indicated only for patients with MR resulting from mitral valve abnormalities, dubbed primary or degenerative MR.

“We now know fixing the valve matters. The MitraClip improves survival,” said William Abraham, M.D., director of the Cardiovascular division, The Ohio State University, one of the principal investors in the COAPT trial. “I would consider this a landmark trial and a real game-changer for our patients. It is the first time we have ever seen in any randomized, controlled trial an outright reduction in heart failure hospitalizations, all-cause mortality, and improvements in quality of life and exercise to a tremendous magnitude.”

The MitraClip is designed to reduce moderate-to-severe MR, a condition where a leakage of blood flows backwards through the mitral valve into the left atrium of the heart. This condition can cause symptoms of heart failure, like fatigue, leg swelling, and shortness of breath.

Heart failure is an abundant condition in the United States, with 6.5 million American adults living with heart failure; it is a progressive, chronic condition, due to the heart being unable to pump the blood necessary for maintaining the body’s oxygen levels in blood. Of these patients, those afflicted with MR as well have additional risk of complications during the treatment of their heart failure. Therefore, the MitraClip is a minimally invasive therapy that opens treatment opportunities for a percentage of patients with difficult-to-treat conditions.

“Expanding the approval of this device to heart failure patients with significant secondary mitral regurgitation, who have failed to get symptom relief from other therapies, provides an important new treatment option,” said Bram D. Zuckerman, M.D, director of the Division of Cardiovascular Devices in the Center for Devices and Radiological Health. “Careful evaluation by a team of specialists is essential to determining whether a particular patient is an appropriate candidate for this procedure.”

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For Further Information

More on the interventional cardiology market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Interventional Cardiology Devices.