Mental HealthUse Of The MitraClip(R) Therapy Continues To Expand In Europe, First 100 Patients Treated
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.
Evalve, Inc.