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Evalve, Inc.: First 100 Patients Treated in Europe with the MitraClip(R) System for Percutaneous Mitral Repair


5/15/2009 9:08:14 AM

Use of the MitraClip(R) Therapy Continues to Expand in Europe

MENLO PARK, Calif., May 14 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today that the first 100 patients have been treated with the MitraClip(R) system in Europe. Clinical results to date underscore the acute clinical benefit for patients, demonstrate the potential for reduced hospital stays and improved quality-of-life for patients. Of the procedures performed to date, 93% resulted in an implant and the vast majority resulted in a satisfactory reduction of mitral regurgitation, as described by the physician at the time of the procedure. The MitraClip(R) system is the only medical device commercially available in the European Union which provides a non-surgical mitral valve repair option for patients suffering from the effects of functional or degenerative mitral regurgitation (MR).

MR is the most common type of heart valve insufficiency in Europe and the United States, affecting millions of people worldwide. Significant MR affects more than eight million people in the US and Europe, the majority of which have FMR. There are more than 600,000 new diagnoses of significant MR each year in Europe and the US; however only 20 percent of these patients undergo surgery each year. Many higher risk surgical patients and non-surgical patients continue to be affected by the chronic volume overload caused by MR, which requires the heart to work harder, and may ultimately lead to heart failure.

"We have seen that the MitraClip(R) therapy provides a valuable alternative for patients who are considered high risk or otherwise not good candidates for surgery," said Olaf Franzen, M.D., interventionalist for adult structural and congenital heart disease at the University Heart Center in Hamburg, Germany, the institution having treated the most patients to date in Europe. "With the MitraClip(R) therapy, because we have observed a strong safety profile, we are able to improve the quality of life for many patients suffering from MR who otherwise would not have been able to receive treatment for their condition."

"The MitraClip(R) therapy has not only played a key role for patients considered too high-risk for surgery, but has also been shown to be effective in selected surgical candidates," added Francesco Maisano, M.D., cardiovascular surgeon at Hospital San Rafaelle, Milan, Italy. "As a cardiac surgeon, I believe that this technology has expanded the options available to physicians to the benefit of the patient suffering from MR."

As of today, patients have been treated with the MitraClip(R) system at fourteen institutions throughout Europe including the University Heart Center, Hamburg, Germany; Cardiovascular Center Frankfurt, Frankfurt, Germany; University Hospital Aachen, Aachen, Germany; University Hospital Essen, Essen, Germany; University Medicine Gottingen, Gottingen, Germany; Bernau Hospital and Heart Center, Brandenburg, Germany; Ferrarotto Hospital, Univeristy of Catania, Sicily, Italy ; Hospital San Rafaelle, Milan, Italy; St. Antonius Hospital, Nieuwegein, Utrecht, Netherlands; Cardiocentro Ticino, Lugano, Switzerland; University Hospital, Zurich, Switzerland; Castle Hill Hospital, Hull, UK; Imperial College Hospital, London, UK; and the Academic Medical Center, Amsterdam, Netherlands.

"The successful treatment of the 100th patient in Europe with the MitraClip(R) system is an important milestone for Evalve," said Ferolyn Powell, president and chief executive officer of Evalve. "We have been pleased with expansion in the number of customers, the acceleration of the implant rate and the very positive response from physicians with regards to their ability to quickly learn and successfully perform the procedure. This, combined with their strong belief in the value of the therapy for their patients, and the potential health economic benefits are driving expansion and increasing the adoption of the MitraClip(R) therapy in Europe."

Evalve initiated commercial sales of the MitraClip(R) system in Europe under the CE Mark in September 2008. The company is employing a direct sales strategy and is taking a disciplined and measured approach to the initial commercial roll out. The company has worked closely with hospitals to deliver high quality training programs in preparation for the first series of implants.

About the MitraClip(R) Procedure

Percutaneous mitral repair with Evalve's MitraClip(R) 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(R) 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, Calif., 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 procedure using the MitraClip(R) device, visit www.evalveinc.com. Evalve is the first portfolio company from the medical device company incubator, The Foundry (www.thefoundry.com).

The MitraClip(R) system is currently undergoing clinical evaluation in the United States and Canada.

MitraClip(R) and Evalve(R) are registered trademarks of Evalve, Inc.

CONTACT: Lisa Waters of Edelman, +1-323-202-1051, Lisa.Waters@edelman.com,
for Evalve, Inc.

Web site: http://www.evalveinc.com/
http://www.thefoundry.com/


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