“We have seen that the MitraClip therapy provides a valuable alternative for patients who are considered high risk or otherwise not good candidates for surgery,” said Olaf Franzen, M.D., interventionalist for adult structural and congenital heart disease at the University Heart Center in Hamburg, Germany, the institution having treated the most patients to date in Europe. “With the MitraClip therapy, because we have observed a strong safety profile, we are able to improve the quality of life for many patients suffering from MR who otherwise would not have been able to receive treatment for their condition.”
“The MitraClip therapy has not only played a key role for patients considered too high-risk for surgery, but has also been shown to be effective in selected surgical candidates,” added Francesco Maisano, M.D., cardiovascular surgeon at Hospital San Rafaelle, Milan, Italy. “As a cardiac surgeon, I believe that this technology has expanded the options available to physicians to the benefit of the patient suffering from MR.”
As of the present day patients have been treated with the MitraClip system at fourteen institutions throughout Europe including the University Heart Center, Hamburg, Germany; Cardiovascular Center Frankfurt, Frankfurt, Germany; University Hospital Aachen, Aachen, Germany; University Hospital Essen, Essen, Germany; University Medicine Göttingen, Göttingen, Germany; Bernau Hospital and Heart Center, Brandenburg, Germany; Ferrarotto Hospital, Univeristy of Catania, Sicily, Italy ; Hospital San Rafaelle, Milan, Italy; St. Antonius Hospital, Nieuwegein, Utrecht, Netherlands; Cardiocentro Ticino, Lugano, Switzerland; University Hospital, Zurich, Switzerland; Castle Hill Hospital, Hull, UK; Imperial College Hospital, London, UK; and the Academic Medical Center, Amsterdam, Netherlands .
“The successful treatment of the 100th patient in Europe with the MitraClip system is an important milestone for Evalve,” said Ferolyn Powell, president and chief executive officer of Evalve. “We have been pleased with expansion in the number of customers, the acceleration of the implant rate and the very positive response from physicians with regards to their ability to quickly learn and successfully perform the procedure. This, combined with their strong belief in the value of the therapy for their patients, and the potential health economic benefits are driving expansion and increasing the adoption of the MitraClip therapy in Europe. 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.
