Advertisement

January 18, 2010

Invatec's Reef HP PTA Balloon Catheter Cleared

January 19, 2010—Invatec (Roncadelle, Italy) announced that it received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Reef HP percutaneous transluminal angioplasty (PTA) balloon catheter for use in peripheral high-pressure dilatation procedures. (On January 25, Medtronic, Inc. [Minneapolis, MN] announced that it will acquire Invatec [see page 14].)

The company stated that the lesion-specific design of the balloon material is particularly useful in patients with a range of peripheral lesions, such as dialysis patients, whose arteriovenous shunts often create fibrous and hard-to-dilate lesions, the company stated. The Reef HP balloon is made from Invatec's Flexitec XF material with a working-pressure range of up to 22 atm, a low compliant balloon, and low-profile design. In the United States, the balloon is available in diameters of 4 to 8 mm and lengths of 20 to 80 mm, Invatec advised.

“We often encounter calcified and resistant lesions in peripheral vessels and in hemodialysis access interventions,” commented Robert L. Vogelzang, MD. “Invatec's addition of a high-pressure PTA balloon will aid in the successful treatment of these challenging lesions.”

Advertisement


January 19, 2010

Data Presented on Cook's REFORM Trial at ISET

January 19, 2010

Data Presented on Cook's REFORM Trial at ISET