FDA clears Invatecs new PTA balloon catheter

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Invatec has received the FDA’s 510(k) clearance to market its Reef HP, a percutaneous transluminal angioplasty (PTA) balloon catheter, for use in peripheral high pressure dilatation procedures.

The REEF HP balloon is made from Invatec’s proprietary Flexitec XF, with a pressure range of up to 22 atm, offering control during high pressure procedures, according to the Roncadelle, Italy-based company. The low compliant balloon offers a dilatation force and shape retention to dilate resistive lesions. The balloon is now available in the U.S. from diameters of 4 to 8 mm and lengths of 20 to 80 mm.