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First-in-Human Clinical Case Successful Using Ultrasound to Cure Mitral Regurgitation

By MedImaging International staff writers
Posted on 19 Oct 2010
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The successful completion of a first-in-human procedure was recently announced using ultrasound therapy to treat mitral regurgitation (MR).

The study data were presented September 26, 2010, by ultrasound heart valve therapy company ReCor Medical (Ronkonkoma, NY, USA), at the Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting in Washington D.C. (USA).

The procedure was performed by Prof. Dr. med Karl-Heinz Kuck, from the Asklepios Klinik St. Georg (Hamburg, Germany). The patient was a 79-year-old male with severe MR (3+). The procedure highlights: femoral-vein access; three-dimensional (3D)/2D echocardiogram; less than 90 minutes. The study's findings confirmed safety and performance, and an MR reduction to 1+.

"Our ultrasound therapy is a whole new modality for treating MR,” said Mano Iyer, founder and CEO of ReCor Medical. "Ultrasound creates heat. Heat shrinks collagen. Shrinkage reduces the mitral valve annulus, and annular reduction reduces MR. Our clinical value proposition is very attractive as our treatment has no implant,” said Mr. Iyer. "Also, our platform is designed to immediately and significantly reduce MR within a very short procedure time. Additionally, use of our system does not restrict a patient from other treatments.”

"The device was extremely easy to use and the fact that you do not implant anything makes this a breakthrough in mitral valve repair,” added Prof. Kuck.

"As a cardiac surgeon, I believe this is an historic moment, as this represents the first time ever that a patient has been treated without leaving anything behind,” stated Prof. Jacques Séguin, M.D., Ph.D., founder and former chairman/CEO of CoreValve and chairman of ReCor. "We also see an application for tricuspid regurgitation, which means we can truly revolutionize the treatment of cardiac valve insufficiency.”

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