Invatec launches drug-eluting balloon to treat atherosclerosis below the knee

Invatec, a comprehensive innovator of interventional products, today announced the European launch of a new peripheral balloon, the IN.PACT Amphirion paclitaxel-eluting PTA balloon catheter.

This is the first drug-eluting catheter designed specifically to treat atherosclerosis in arteries located below the knee (BtK). IN.PACT features FreePac, a proprietary coating that frees and separates paclitaxel molecules and facilitates their absorption into the wall of the artery.

The FreePac coating was developed in close collaboration with the researchers who pioneered drug-eluting balloon therapy, Ulrich Speck, Ph.D., Department of Radiology at Charite Mitte, Berlin and Bruno Scheller, M.D., University Hospital, Department of Internal Medicine, Homburg/Saar. "According to research published in the New England Journal of Medicine 1 and Circulation 2 , drug-eluting balloons utilizing a special drug elution formulation have demonstrated effectiveness in the treatment of atherosclerosis and the prevention of restenosis," commented Andrea Venturelli and Stefan Widensohler, co-founders of Invatec. "Invatec is taking this approach further by offering a drug elution therapy targeted specifically for below the knee interventions and placing it on a market-leading, state-of-the-art platform, the Amphirion Deep balloon catheter."

Invatec plans to launch a randomized trial, the IN.PACT DEEP study, in the first half of 2009, to provide additional data about the effectiveness of this new treatment concept.

"After years of research we are pleased to see this technology available for clinical applications," commented Prof. Speck and Prof. Scheller. "The drug-eluting balloon concept has the potential to reduce re-intervention rates for patients with atherosclerosis. Invatec's balloon technology is an ideal platform for the FreePac coating and will allow for the development of specific solutions for additional endovascular applications including the superficial femoral artery (SFA)."

Prof. Dierk Scheinert, course director of the LINC interventional course in Leipzig, commented on the first IN.PACT Amphirion procedure, "Combining conventional balloon dilatation with local drug administration is a fascinating new concept for this patient group. Stents may not be a feasible option for the majority of BtK patients with advanced disease. The IN.PACT Amphirion therefore holds promise as an effective treatment for this challenging patient population."

Impaired blood flow caused by blockages below the knee, also known as Critical Limb Ischemia (CLI) result in pain, poor wound healing, gangrene and a high risk of death. According to data published in Wounds, 40 percent of patients require amputation within 12 months of a CLI episode, and there is an annual mortality rate of more than 20 percent.

In addition to IN.PACT Amphirion, Invatec offers a full, dedicated product line for below the knee artery treatment, including the Amphirion DEEP 0.014" balloon catheter, the 0.014" Skipper DEEP guide wire, the Chromis DEEP 0.014" balloon-expandable stent and the new Maris DEEP 0.018" self-expandable stent.

About Invatec :

Invatec is a comprehensive innovator of vascular interventional products with global headquarters based in Italy. 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. The company's core competencies include polymer processing, metal technology and surface technology. Invatec is vertically integrated with full in-house capabilities to design, develop, manufacture and assemble the 35 product families that are offered in more than 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 1000 employees. For more information, visit www.invatec.com.