MENLO PARK, Calif., March 25 Evalve, Inc., the leader inthe development of devices for the percutaneous repair of cardiac valves,announced today CE Mark approval for its MitraClip(R) system. The MitraClip isthe first commercially available device which enables a non-surgical optionfor patients suffering from the effects of mitral regurgitation (MR).
MR is the most common type of heart valve insufficiency in the UnitedStates and the second most common in Europe, affecting millions of peopleworldwide. Both in the United States and Europe, the vast majority of patientsare untreated, which leaves their hearts affected by the chronic volumeoverload caused by MR, requiring the heart to work harder, and ultimatelyleading to heart failure.
CE Mark approval gives Evalve the ability to train and educate physiciansin Europe on the use of the MitraClip device increasing the number of patientswho will potentially benefit from this innovative treatment. Evalve will workwith hospitals across Europe to establish training programs which will allowphysicians to gain access to this new technology.
"The progress we have made, notably the milestones achieved in the EVERESTtrial and receiving CE Mark approval, are important as we move towardcommercialization in Europe and the U.S.," said Ferolyn Powell, president andchief executive officer of Evalve. "We believe the MitraClip system has thepotential to benefit patients who currently suffer from the serious effects ofMR. Oftentimes patients in consultation with their doctors choose not toundergo surgical treatment because of the associated risks and trauma.However, until now surgery was the only available treatment option. TheMitraClip offers the patients a new alternative."
EVEREST investigators are currently enrolling patients in the randomizedarm of the study with the goal of completing enrollment by the end of 2008.
More information about the EVEREST trial is available athttp://www.mitralregurgitation.org
About the MitraClip Procedure
Percutaneous mitral repair with Evalve's MitraClip device is performed byinterventional cardiologists in the catheterization laboratory. The heartbeats normally during the procedure, and therefore does not require aheart-lung bypass machine. In addition to improving blood flow through theheart, the procedure may also relieve symptoms such as fatigue and shortnessof breath that often affect patients with significant MR. After treatment,patients generally recover quickly. The MitraClip device may improve qualityof life and may help MR patients avoid or delay surgery, having preservedsurgical options (valve repair or replacement) should surgery becomenecessary.
About Evalve, Inc.
Evalve, Inc. (Menlo Park, Calif.) was incorporated in 1999 to design,develop, manufacture, and market innovate devices to enable percutaneousrepair of cardiac valves. The company's initial products are intended toreduce the risks, trauma and costs associated with current open, arrestedheart surgical options. The company's present development and clinical effortsare focused on mitral valve repair. For more information about Evalve, Inc.,and for an animated explanation of the Percutaneous Mitral Repair procedureusing the MitraClip device, visit http://www.evalveinc.com. Evalve is thefirst portfolio company from the medical device company incubator, The Foundry(http://www.thefoundry.com).
MitraClip and Evalve are registered trademarks of Evalve, Inc.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.