First European Patients Treated With The Percutaneous MitraClip(R) System

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 24 Sep 2008 - 0:00 PDT

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Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced that the first two patients have been treated with its MitraClip(R) system in Hamburg, Germany. The MitraClip system is the first commercially available device which enables a non-surgical option for patients suffering from the effects of mitral regurgitation (MR).

MR is the second most common type of heart valve insufficiency in Europe, and the most common in the United States, affecting millions of people worldwide. Both in Europe and the United States, the vast majority of patients are untreated, which leaves their hearts affected by the chronic volume overload caused by MR, requiring the heart to work harder, and ultimately leading to heart failure.

The first European patients were treated by the team led by Olaf Franzen, M.D., Dietmar Koschyk, M.D., Hendrik Treede, M.D., and Professor Joachim Schofer, M.D. at the University Heart Center in Hamburg, Germany.

"The immediate results after implanting the MitraClip device have surpassed our initial expectations," said Dr. Franzen, interventionalist for adult structural and congenital heart disease at the University Heart Center.

"The patients we treated last week have heart failure and were considered to be high risk surgical patients," said Professor and Chairman Thomas Meinertz M.D., Ph.D. at the University Heart Center. "Now with the availability of the MitraClip system, we are able to treat these patients with a much less invasive percutaneous alternative for mitral repair."

"This new therapy may be an excellent alternative for this group of patients with heart failure," said Professor Herrmann Reichenspurner, M.D., Ph.D, Head of Cardiac Surgery and Medical Director at the University Heart Center. "As a cardiac surgeon, there are times when operating on this type of patient is not feasible due to the high risk of mortality and post operative morbidity. Now there is another treatment option."

The MitraClip system is commercially available in Europe and the company has initiated training in support of the European launch. Five additional treatment centers are in the process of scheduling treatment of their first group of patients. These sites include Glenfield Hospital, Leicester, United Kingdom; Hospital San Rafaelle, Milan, Italy; Cardiovascular Center Frankfurt, Frankfurt, Germany; Ferratoto Hospital, Catania, Italy; Academic Medical Center, Amsterdam, The Netherlands.

"These first procedures in Europe mark a significant milestone for people worldwide suffering from the serious effects of MR," said Ferolyn Powell, president and chief executive officer of Evalve. "The MitraClip system offers a new alternative to surgery for mitral valve repair which up until now was the only option to intervene. Oftentimes, patients in consultation with their doctors chose not to undergo surgery because of the associated risks and trauma."

About the MitraClip Procedure

Percutaneous mitral repair with Evalve's MitraClip device is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly. The MitraClip device may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.

About Evalve, Inc.

Founded in 1999, Evalve, Inc. -- headquartered in Menlo Park, California -- has developed a proprietary system which enables percutaneous repair of cardiac valves. The company's initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. For more information about Evalve, Inc., and for an animated explanation of the Percutaneous Mitral Repair procedure using the MitraClip device, visit http://www.evalveinc.com. Evalve is the first portfolio company from the medical device company incubator, The Foundry (http://www.thefoundry.com).

The MitraClip System is currently undergoing clinical evaluation in the United States and Canada.

MitraClip and Evalve are registered trademarks of Evalve, Inc.

Evalve, Inc
http://www.evalveinc.com