Healthcare Industry News:  Invatec 

Devices Interventional FDA

 News Release - January 19, 2010

Invatec Receives 510(k) Clearance of REEF HP PTA Balloon Catheter

New High Pressure Catheter Specifically Designed for Effective Treatment of Challenging Peripheral Lesions

HOLLYWOOD, Fla.--(HSMN NewsFeed)--Invatec, a comprehensive innovator of cardiovascular products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its REEF HP™, a PTA Balloon Catheter, for use in peripheral high pressure dilatation procedures. The “lesion-specific” design of the balloon material is particularly useful in hard-to-dilate situations.

“We are pleased to announce the FDA clearance of REEF HP, a strong and highly stable balloon, designed specifically to treat the most demanding lesions with a high pressure threshold,” commented Stefan Widensohler and Andrea Venturelli, co-founders of Invatec. “The ‘lesion-specific’ design of REEF HP makes the balloon ideal for use in patients with a range of peripheral lesions, such as dialysis patients whose AV shunts often create fibrous and hard-to-dilate lesions.”

The REEF HP balloon is made from Invatec’s proprietary Flexitec™ XF, an extremely durable material with a large working pressure range of up to 22 atm, offering excellent control during high pressure procedures. The low compliant balloon offers a uniform dilatation force and strong shape retention to dilate resistive lesions with greater stability and success. REEF HP’s low-profile design enables consistent delivery and ease of crossability. The balloon is now available in a wide range of sizes in the U.S. 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,” commented Robert L. Vogelzang, M.D., Professor of Radiology at Northwestern University Medical School and Chief of Vascular and Intentional Radiology at Northwestern Memorial Hospital. “Invatec’s addition of a high pressure PTA balloon will aid in the successful treatment of these challenging lesions.”

“REEF HP is an exciting new addition to our PTA product line and further underscores our commitment to offering a comprehensive range of peripheral solutions,” commented Jack Springer, president of Invatec USA. “The FDA clearance of REEF HP provides physicians with a tool specifically designed to treat resistive lesions and will complement our other PTA balloons.”

About Invatec

Headquartered in Italy and with manufacturing in Italy and Switzerland, Invatec is one of the world’s fastest growing companies in the design, development and production of interventional cardiology and peripheral vascular products for the treatment of coronary and peripheral arterial disease. Driven by research and technology, Invatec actively collaborates with physicians and centers of excellence to develop products that will improve life expectancy and quality of life for patients. Vertically integrated, Invatec also has the in-house ability to design, develop, manufacture and assemble its entire product offering from raw materials. As a result, the company has one of the largest therapeutic catheter product lines in the world, including 9 stent platforms, 6 angioplasty balloon platforms, 4 drug-eluting balloon platforms and accessory devices, now sold in over 70 countries.

Dedicated to “making ideas come alive,” the company was founded in 1996 by Andrea Venturelli and Stefan Widensohler and has grown to almost 1,000 employees. For more information, visit www.Invatec.com.


Source: Invatec

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