First Dutch Patients Treated with the Percutaneous Mitraclip® System
First Dutch Patients Treated with the Percutaneous Mitraclip® System
Use of the MitraClip® System Continues to Expand in the European Union
February 12, 2009 – MENLO PARK, Calif. – 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® system at the St. Antonius Hospital, Nieuwegein, Utrecht, Netherlands. The MitraClip® 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® 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® system will play a key role for these patients.”
Evalve initiated commercial sales of the MitraClip® 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® device is currently being implanted in four countries, including Germany, Italy, the United Kingdom and now the Netherlands.
“Customer feedback about the MitraClip® system has been exceptional. Physicians have experienced a quick procedural learning curve and have commented positively on the ease of use of the MitraClip® 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® 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® 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, 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® device, visit www.evalveinc.com. Evalve is the first portfolio company from the medical device company incubator, The Foundry (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.
Media Contact:
Amy Hytowitz
Edelman
1-323-202-1028
Amy.Hytowitz@edelman.com
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