High-Pressure Balloon Introduced for Challenging Peripheral Lesions


January 20, 2010

January 20, 2010 – The balloon material of the new REEF HP PTA Balloon Catheter was created for use in peripheral high-pressure dilatation procedures, especially to treat hard-to-dilate lesions. The balloon received FDA 510(k) clearance this week.

Invatec said its new balloon can treat a range of peripheral lesions, including dialysis patients whose arteriovenous shunts often create fibrous and hard-to-dilate lesions.

The REEF HP balloon is made from Flexitec XF, an extremely durable material with a large working pressure range of up to 22 atm. The low compliant balloon offers a uniform dilatation force and strong shape retention to dilate resistive lesions with greater stability and success. Its low-profile design enables consistent delivery and ease of crossability. The balloon is available in a wide range of sizes, from diameters of 4-8 mm and lengths of 20-80 mm.

“We often encounter calcified and resistant lesions in peripheral vessels and in hemodialysis access interventions,” said Robert L. Vogelzang, M.D., professor of radiology at Northwestern University Medical School and chief of vascular and interventional radiology at Northwestern Memorial Hospital. “Invatec’s addition of a high pressure PTA balloon will aid in the successful treatment of these challenging lesions.”

For more information: www.invatec.com