MENLO PARK, Calif., March 25 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today CE Mark approval for its MitraClip(R) system. The MitraClip 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 most common type of heart valve insufficiency in the United States and the second most common in Europe, affecting millions of people worldwide. Both in the United States and Europe, 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.
CE Mark approval gives Evalve the ability to train and educate
physicians in Europe on the use of the MitraClip device increasing the
number of patients who will potentially benefit from this innovative
treatment. Evalve will work with hospitals across Europe to establish
training programs which will allow physicians to gain access to this new
In addition to CE Mark approval, company highlights include:
-- High Risk Registry Study Arm Enrollment Completed: Evalve recently
completed enrollment in the high-risk registry arm of the Endovascular
Valve Edge-to-Edge REpair STudy (EVEREST) in North America. Patients
who are high risk surgical candidates may benefit from a less invasive
procedure. Investigators are collecting follow-up data to assess the
risk-benefit profile from the less invasive percutaneous intervention
with the MitraClip device.
-- Continued Progress with EVEREST Trial: The EVEREST investigators from
more than 40 sites across North America have reached additional
milestones in the ongoing FDA-approved Phase II clinical study. EVEREST
Investigators have treated more
|SOURCE Evalve, Inc.|
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