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MitraClip System From Evalve Treats First Group Of Patients In Sweden

Evalve, Inc. (Evalve), a developer and manufacturer of devices for percutaneous repair of cardiac valves, has treated the first group of subjects with the MitraClip system at the Karolinska University Hospital in Solna, Stockholm, Sweden. The MitraClip system is the only device in the Europe to provides a minimally inavasive mitral valve repair option for patients with functional and degenerative mitral regurgitation (MR).

The first patients in Sweden were successfully treated by a team led by cardio-thoracic surgeon Anders Jonsson, M.D., Ph.D., assisted by interventional cardiologist Magnus Settergren, M.D., Ph.D. Echocardiography was performed by cardiac anesthetist Jan Hultman, M.D., Ph.D. and clinical cardiologist Reidar Winter, M.D., Ph.D.

The MitraClip technology has added a new dimension to the treatment of mitral regurgitation. In my initial experience with our first three patients, I was very pleased to see the good result achieved with a single clip in each of our patients. Any less invasive approach for heart valve procedures is worthwhile to consider, especially if the long term results are compatible with the techniques requiring an open thorax. I am looking forward to treat more patients to further evaluate this approach, said Dr. Hultman, Director of the Clinic in Cardiothoracic Surgery and Anesthesia. It is very satisfactory for us as a unit to be able to offer this technology to some of our patients. The MitraClip is a device that hopefully will enable us to design the optimal treatment for all different types of patients with MR including high risk and inoperable candidates, added Dr. Jonsson who led the team.

Evalve initiated commercial sales of the MitraClip system in Europe under the CE Mark in late 2008. The company is employing a direct sales strategy and is taking a disciplined and measured approach to the initial commercial roll out. Evalve has worked closely with hospitals to deliver high quality training programs in preparation for the first series of implants and offers ongoing support. The MitraClip device is currently being implanted in six Western European countries, including Germany, Italy, the United Kingdom, the Netherlands, Switzerland and now Sweden.

We are very pleased with the successful initial use of the MitraClip device in Sweden at this cardiac center, said Ferolyn Powell, president and chief executive officer of Evalve. It is noteworthy that the MitraClip therapy can be delivered to patients by both interventional cardiologists and cardiothoracic surgeons in close collaboration with their colleagues in echocardiology. The centers offering the MitraClip therapy in Europe are pioneering a new field and era in the medical care for patients who suffer from mitral regurgitation, especially for those who, until now, had very limited therapeutic options.

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.