ATLANTA, March 14 (Reuters) - An experimental, minimally invasive technique to repair the most common type of heart valve problem proved to be far safer and nearly as effective as open heart surgery, meeting the primary goals of a pivotal study, researchers said on Sunday.
Abbott Laboratories is hoping to use the data to win U.S. approval for the mitral valve repair device. Its MitraClip has been available in Europe for about 18 months.
In the first large trial of its kind, researchers compared the Abbott device -- delivered to the heart via a catheter through a blood vessel in the leg -- with open heart surgery to treat mitral regurgitation, or MR.
The primary safety goal of the study compared the number of major adverse events -- a composite of 12, including major stroke, re-operation of mitral valve, urgent cardiovascular surgery, heart attack, kidney failure, major bleeding, and death -- at 30 days.
Among patients who received the MitraClip, 9.6 percent suffered major adverse events compared with 57 percent in the surgery group, a difference considered to be highly statistically significant. In the surgery group, 42 of the 55 adverse events were major bleeding, researchers said.
MR, which affects more than 8 million people in the United States and Europe, is marked by a faulty mitral valve that does not close tightly enough, allowing blood to flow backward in the heart. MR is a debilitating condition in which the heart's ability to function deteriorates over time, and can lead to irregular heartbeat, heart failure, stroke, heart attack or death.
(Reporting by Debra Sherman and Bill Berkrot; editing by Paul Simao) Keywords: HEART ABBOTT/VALVE (debra.sherman@thomsonreuters.com; + 312 408 8134; Reuters Messaging: debra.sherman.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
Abbott Laboratories is hoping to use the data to win U.S. approval for the mitral valve repair device. Its MitraClip has been available in Europe for about 18 months.
In the first large trial of its kind, researchers compared the Abbott device -- delivered to the heart via a catheter through a blood vessel in the leg -- with open heart surgery to treat mitral regurgitation, or MR.
The primary safety goal of the study compared the number of major adverse events -- a composite of 12, including major stroke, re-operation of mitral valve, urgent cardiovascular surgery, heart attack, kidney failure, major bleeding, and death -- at 30 days.
Among patients who received the MitraClip, 9.6 percent suffered major adverse events compared with 57 percent in the surgery group, a difference considered to be highly statistically significant. In the surgery group, 42 of the 55 adverse events were major bleeding, researchers said.
MR, which affects more than 8 million people in the United States and Europe, is marked by a faulty mitral valve that does not close tightly enough, allowing blood to flow backward in the heart. MR is a debilitating condition in which the heart's ability to function deteriorates over time, and can lead to irregular heartbeat, heart failure, stroke, heart attack or death.
(Reporting by Debra Sherman and Bill Berkrot; editing by Paul Simao) Keywords: HEART ABBOTT/VALVE (debra.sherman@thomsonreuters.com; + 312 408 8134; Reuters Messaging: debra.sherman.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
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