May 10, 2012 - Loma Vista Medical (“LVM”) announced that it has received CE mark for its TRUE Dilatation™ Balloon Valvuloplasty Catheter. The company has seen rapid adoption at major clinical centers and will be launching its initial product at next week’s EuroPCR congress in Paris (Booth #M22, Paris Convention Center Palais des Congrès).
Fabricated from tough, high-strength materials and designed to prevent the catastrophic failures seen with other heart valve dilatation balloons, the TRUE Dilatation Balloon is highly resistant to ruptures, punctures, and tears. Studies funded by the U.S. National Heart, Lung and Blood Institute (NHBLI) and others have reported a 10% to 17% failure rate in conventional balloons used in BAV (balloon aortic valvuloplasty) and TAVI (transcatheter aortic valve implantation) procedures... [PDF] Loma Vista Medical's Press Release -