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First Dutch Patients Treated With the Percutaneous MitraClip(R) System

Friday, February 13, 2009 General News J E 4
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MENLO PARK, Calif., Feb. 12 Evalve, Inc., the leader inthe development of devices for the percutaneous repair of cardiac valves,announced today that the first series of patients have been successfullytreated with the MitraClip(R) system at the St. Antonius Hospital, Nieuwegein,Utrecht, Netherlands. The MitraClip(R) system is the only medical devicecommercially available in the European Union which provides a non-surgicalmitral valve repair option for patients suffering from the effects of mitralregurgitation (MR).

Mitral regurgitation is the most common type of heart valve insufficiencyin Europe and the United States, affecting millions of people worldwide. Inthe vast majority of patients, the MR is untreated, requiring the heart towork harder and ultimately leading to heart failure.

The first patients in the Netherlands were treated by the team led by J.Van der Heyden, M.D., assisted by B.J.W.M. Rensing, M.D., PhD.; F.D. Eefting,M.D.; W. Jaarsma, M.D., PhD.; and A. Yilmaz, M.D.

"The MitraClip(R) therapy provides a valuable alternative for thosepatients who are not good candidates for surgery," said Dr. Van der Heyden,department of interventional cardiology. Dr. Yilmaz, department ofcardiothoracic and cardiovascular surgery added, "Until now heart failurepatients with associated functional MR had no therapeutic options exceptmedical management when surgery was not considered a good option. We believethe MitraClip(R) system will play a key role for these patients."

Evalve initiated commercial sales of the MitraClip(R) system in Europeunder the CE Mark in September 2008. The company is employing a direct salesstrategy and is taking a disciplined and measured approach to the initialcommercial roll out. The company has worked closely with hospitals to deliverhigh quality training programs in preparation for the first series ofimplants. The MitraClip(R) device is currently being implanted in fourcountries, including Germany, Italy, the United Kingdom and now theNetherlands.

"Customer feedback about the MitraClip(R) system has been exceptional.Physicians have experienced a quick procedural learning curve and havecommented positively on the ease of use of the MitraClip(R) system," saidFerolyn Powell, president and chief executive officer of Evalve. "The mostimpressive physician responses have been based on the immediate observation ofMR reduction and the resultant relief of symptoms in heart failure patients.Additionally, we hear positive comments on the physician's ability to placethe MitraClip(R) device on the beating heart without difficulty and how stablethe patients are during the procedure. Evalve will continue to work diligentlyto make the technology available throughout the European Union."

About the MitraClip(R) Procedure

Percutaneous mitral repair with Evalve's MitraClip(R) device is performedby physicians in the catheterization laboratory. The heart beats normallyduring the procedure, and therefore does not require a heart-lung bypassmachine. In addition to improving blood flow through the heart, the proceduremay also relieve symptoms such as fatigue and shortness of breath that oftenaffect patients with significant MR. After treatment, patients generallyrecover quickly. The MitraClip(R) device may improve quality of life and mayhelp 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., hasdeveloped a proprietary system which enables percutaneous repair of cardiacvalves. The company's initial products are intended to reduce the risks,trauma and costs associated with current open, arrested heart surgicaloptions. For more information about Evalve, Inc., and for an animatedexplanation of the procedure using the MitraClip(R) device, visithttp://www.evalveinc.com. Evalve is the first portfolio company from themedical device company incubator, The Foundry (http://www.thefoundry.com).

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

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

SOURCE Evalve, Inc.
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