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

February 12, 2009

MENLO PARK, Calif., Feb. 12 /PRNewswire/ — Evalve, Inc., the leader in
the development of devices for the percutaneous repair of cardiac valves,
announced today that the first series of patients have been successfully
treated with the MitraClip(R) system at the St. Antonius Hospital, Nieuwegein,
Utrecht, Netherlands. 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 mitral
regurgitation (MR).

Mitral regurgitation is the most common type of heart valve insufficiency
in Europe and the United States, affecting millions of people worldwide. In
the vast majority of patients, the MR is untreated, requiring the heart to
work 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 those
patients who are not good candidates for surgery,” said Dr. Van der Heyden,
department of interventional cardiology. Dr. Yilmaz, department of
cardiothoracic and cardiovascular surgery added, “Until now heart failure
patients with associated functional MR had no therapeutic options except
medical management when surgery was not considered a good option. We believe
the MitraClip(R) system will play a key role for these patients.”

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. The MitraClip(R) device is currently being implanted in four
countries, including Germany, Italy, the United Kingdom and now the
Netherlands
.

“Customer feedback about the MitraClip(R) system has been exceptional.
Physicians have experienced a quick procedural learning curve and have
commented positively on the ease of use of the MitraClip(R) system,” said

Ferolyn Powell, president and chief executive officer of Evalve. “The most
impressive physician responses have been based on the immediate observation of
MR reduction and the resultant relief of symptoms in heart failure patients.
Additionally, we hear positive comments on the physician’s ability to place
the MitraClip(R) device on the beating heart without difficulty and how stable
the patients are during the procedure. Evalve will continue to work diligently
to make the technology available throughout the European Union.”

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
http://www.evalveinc.com. Evalve is the first portfolio company from the
medical device company incubator, The Foundry (http://www.thefoundry.com).

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

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

SOURCE Evalve, Inc.


Source: newswire



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