Early success of transeptal mitral valve annuloplasty device for functional mitral regurgitation

30-31 October 2013

Clinical trial is ongoing at 3 leading European medical centers

Early success of transeptal mitral valve annuloplasty device for functional mitral regurgitation

Valtech Cardio Ltd, a medical device company that develops solutions for mitral valve repair and replacement, announced today that 11 patients have been treated with the company's transcatheter (transfemoral) Cardioband™ Annuloplasty System in three leading European medical centers. A clinical update on the Cardioband study is scheduled to be presented at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) Symposium in San Francisco on October 30-31

The Cardioband device enables transcatheter Mitral Regurgitation (MR) repair, thereby avoiding open heart surgery and the use of cardiac bypass machine. The size of the Cardioband is adjusted while the heart is beating which optimizes the results of the repair. Importantly, the form and clinical function of the Cardioband closely replicates that of the annuloplasty rings that are today’s standard-of-care in surgery.

The patients were treated as part of an ongoing multi-center study at the Asklepios Klinik St. Georg Heart Center in Hamburg, Bichat-Claude Bernard Hospital in Paris and San Raffaele Hospital in Milan. . Enrollment in the trial is expected to be completed in Q1/2014. Dr. Francesco Maisano, Valtech's Chief Medical Officer, commented: "The safety profile of the device is impressive. Throughout these eleven procedures, the Cardioband device has demonstrated an excellent safety profile with no MACE to date." Dr. Maisano added, "Cardioband is the most promising valve repair technology. Early outcomes are extremely favorable with profound reduction of MR in most patients."

Prof. Vahanian, Principal Investigator at Bichat-Claude Bernard Hospital, Paris, who implanted five patients noted, "We have been waiting for a long time for a transcatheter treatment for mitral regurgitation that can reproduce an effective surgical technique. The preliminary results suggest that the Cardioband can do it."

Prof. Karl-Heinz Kuck, Principal Investigator at the Asklepios Klinik St. Georg Heart Center in Hamburg, said: "The Cardioband annuloplasty system provides an excellent alternative for patients who are at high risk to undergo surgery. The procedure is safe and has the potential to become the first-line interventional therapy."

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