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FDA Clears Loma Vista Medical's TRUE Dilatation™ Balloon Valvuloplasty Catheter

10/17/2012 7:30:47 AM

BURLINGAME, Calif., Oct. 17, 2012—Loma Vista Medical ( announced today that its CE-marked TRUE Dilatation™ Balloon Valvuloplasty Catheter has received FDA clearance. The product will be featured from the podium at the “Innovations Symposium” during the upcoming Transcatheter Cardiovascular Therapies (TCT) 2012 congress in Miami (Abstract #1574: “Performance and Safety of the TRUE Dilatation™ Balloon Valvuloplasty Catheter for Aortic Balloon Valvuloplasty in Patients Undergoing TAVI”). In addition, the TRUE Dilatation Balloon will be featured in a Live Case from Ferrarotto Hospital in Catania, Italy, presented at the TCT 2012 congress on Wednesday, October 24 (Hall A - Structural and Endovascular Theater at noon in the Transcatheter Valve Therapies II session). Loma Vista Medical will be exhibiting the TRUE Dilatation™ Balloon Valvuloplasty Catheter at TCT 2012 (Booth 592, Miami Beach Convention Center).

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 up to a 17% failure rate in conventional balloons used in BAV (balloon aortic valvuloplasty) and TAVI (transcatheter aortic valve implantation) procedures.

“Our TRUE Dilatation Balloon represents a new paradigm in valvuloplasty and heart valve prep for TAVI. It clearly comes at a time when heart valve companies need a reliable, high performance balloon,” added Alex Tilson, founder and CEO of Loma Vista Medical. “Our TRUE Dilatation Balloon is designed to be both precise and tough, thereby facilitating exact, controlled and dependable dilatations for BAV and TAVI procedures. Our balloon also has additional important features—fast inflation and deflation—to improve balloon stability while reducing ‘rapid pacing’ time. This is critical: ‘rapid pacing’ is typically used by physicians to stabilize balloon dilatation, but it puts additional stress on a weak heart. Consequently our TRUE Dilatation Balloon is extremely important for treatment of the elderly patients undergoing BAV and TAVI. We are pleased to have an inn ovative product - CE marked and adopted by over 50 of Europe’s top TAVI centers - now also cleared for use in the United States.”

About Loma Vista Medical

Headquartered in Silicon Valley (Burlingame, Calif.), Loma Vista Medical is a venture capital-funded medical device company dedicated to developing the world’s highest performing balloons for Balloon Aortic Valvuloplasty (BAV) and Transcatheter Aortic Valve Implantation (TAVI). The company’s mission is to commercialize products that are an indispensible part of every procedure by creating technology specifically designed to address the clinical challenges of BAV and TAVI.

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