Loma Vista Medical Receives CE Mark for its TRUE Dilatation™ Balloon Valvuloplasty Catheter

BURLINGAME, Calif.--(BUSINESS WIRE)-- Loma Vista Medical (“LVM”, www.lomavistamedical.com) announced today 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 de Congres).

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.

“The most important benefit of the TRUE Dilatation Balloon is dependability,” said Prof. Axel Linke, M.D., an interventional cardiologist at The Heart Center – University Hospital, Leipzig, Germany. “In my experience, I believe that the TRUE Dilatation Balloon is, by far, the most durable and most precise balloon available to pre-dilate a heart valve in preparation for a percutaneous implant and to dilate a heart valve with a valvuloplasty procedure.”

“It is clearly established that heart valve companies need a consistently dependable balloon for valve dilatation in TAVI,” added Alex Tilson, founder and CEO of Loma Vista Medical. “The TRUE Dilatation Balloon is designed to be precise and tough, thus enabling accurate, controlled and reliable dilatations for BAV and TAVI procedures. The balloon also features fast inflation and deflation for reduced rapid pacing time. Rapid pacing is generally used by physicians to facilitate valvuloplasty, but it is known to put additional stress on a frail heart. The TRUE Dilatation Balloon is especially important for treatment of the extremely sick, elderly patients undergoing BAV and TAVI.

“Loma Vista Medical is dedicated to assisting the treatment of these extremely sick, elderly patients by developing TAVI tools that improve reliability and safety and enable physicians to reduce rapid pacing,” added Mr. Tilson. “The TRUE Dilatation Balloon is designed to do exactly that; it represents a new paradigm in percutaneous heart valve prep and valvuloplasty. And our next-generation product will take reliability, precision, and cardiac protection to the next level. We are bullish about our market opportunity and initial European commercialization strategy, which is primarily distributor-focused.”

About Loma Vista Medical

Headquartered in Silicon Valley (Burlingame, California.), 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). Its pioneering 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.

The TRUE Dilatation™ Balloon Valvuloplasty Catheter is not available for sale in the United States.

Contact:

Media Contact:

Ronald Trahan Associates Inc.

Ronald Trahan, APR, +1 508-359-4005, ext. 108

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Corporate Contact:

Loma Vista Medical

Teddy Johnson, +1 650-490-4747, ext. 117