Healthcare Industry News:  Balloon catheter 

Devices Interventional FDA

 News Release - June 19, 2012

TriReme Medical Receives FDA Clearance for Expanded Matrix of Sizes of Chocolate PTA Balloon Catheter

PLEASANTON, Calif., June 19, 2012 -- (Healthcare Sales & Marketing Network) -- TriReme Medical, Inc. (TMI) announced today that it has received FDA clearance for an expanded matrix of sizes for its Chocolate(TM) PTA Balloon catheter. Chocolate(TM) is now approved for the percutaneous transluminal treatment of lesions in the peripheral vasculature in balloon diameters from 2.0 - 4.0mm and in balloon lengths up to 120mm.

"This latest regulatory approval broadening the available size matrix of the Chocolate(TM) PTA Balloon marks yet another important milestone for TriReme Medical," said Eitan Konstantino, President and CEO of TriReme Medical Inc. "There is more to come; our goal is to provide a broad range of innovative tools to improve outcomes in patients suffering from complex vascular disease."

"Chocolate(TM) has become an essential part of my routine practice for treating below the knee lesions," said Dr. Rajesh Dave, Chief Medical Executive and Director at Cardiac Catheterization Laboratories, Holy Spirit Cardiovascular Institute, Camp Hill, PA. "With the approval of these new sizes, I will be able to expand my use of Chocolate(TM) and begin to treat patients with disease in the popliteal artery where we usually prefer not to stent."

About Chocolate(TM): Chocolate's novel design incorporates a constraining structure over a semi-compliant balloon to facilitate the formation of small modules ("pillows"). Through this advanced mechanism of action, Chocolate minimizes shear stress and allows for uniform inflation and rapid deflation. The Chocolate "pillows" can expand locally to facilitate plaque modification and are designed to lower the strain and trauma induced on the vessel wall.

About TriReme Medical, Inc.

Based in Pleasanton, California and Singapore, TriReme Medical, Inc. is a privately held medical device company dedicated to the development, manufacturing, and commercialization of next generation percutaneous devices for the treatment of complex coronary and peripheral arterial disease. The company is focused on the US and the emerging Asian markets.

Source: TriReme Medical

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