October 31, 2008 »»» Mitralign® Initiates it's First European Study

Mitralign, Inc. announced today that it has successfully performed the first two implants of the Mitralign Percutaneous Annuloplasty System(TM) for mitral valve repair in it's European Pilot Study. The procedures were performed by Chief. Dr. med. Eberhard Grube and Dr. med. Lutz Buellesfeld at Helios Heart Center in Siegburg, Germany. Procedures were assisted by Oberarzt Dr. med. Ralf Müller. The Mitralign System was able to significantly reduce the patient's mitral regurgitation.

The Mitralign Percutaneous Annuloplasty System emulates suture mitral annuloplasty surgery without the risk and downside of open heart surgery. The implant was percutaneously delivered though a single 14F femoral arterial sheath, and provided direct geometric reduction of the posterior annulus. Dr. Grube commented, "I was pleased with our ability to navigate in the left ventricle and to see mitral valve regurgitation reduced real time with 2-D and 3-D echo. I am delighted to be part of the team to place the first Mitralign Percutaneous Annuloplasty System in Europe."

The condition treated, mitral valve regurgitation (MR), is common in patients with Congestive Heart Failure (CHF). Clinical studies have proven that MR significantly increases the risk of mortality in patients afflicted with CHF, a disease affecting 25 Million worldwide. Studies hence recommend earlier treatment of MR in these patients.

Combining surgical precision with interventional therapy, Mitralign is developing an innovative, catheter-based method to effectively treat mitral regurgitation in patients suffering from Congestive Heart Failure. Mitralign's goal is to emulate the technique employed in traditional open heart surgery but in a far less invasive manner.

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