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First European Patients Treated With The Percutaneous MitraClip(R) System
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
Prima Europene de pacienþi trataþi cu MitraClip percutanatã (R) de sistem - First European Patients Treated With The Percutaneous MitraClip(R) System - articole medicale engleza - startsanatate