Invatec Receives CE-Mark For Second Drug-Eluting Balloon Platform

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 18 Mar 2009 - 0:00 PDT

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Invatec, a comprehensive innovator of interventional products, announced CE-certification of a new coronary balloon, the IN.PACT™ Falcon paclitaxel-eluting PTCA balloon catheter. This is one of the first drug-eluting balloons designed specifically to treat atherosclerosis in the coronary arteries.

IN.PACT Falcon features FreePac™, a proprietary, natural 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, Mitte, Berlin and Bruno Scheller,Ph.D., Department of Radiology at Charite M.D., University Hospital, Department of Internal Medicine, Homburg/Saar.

"We are extremely excited to commercialize a much-needed product that combines our FreePac coating technology with the performance-leading characteristics of our Falcon PTCA balloon platform, thereby creating a world class drug eluting balloon," commented Andrea Venturelli and Stefan Widensohler, co-founders of Invatec. "The European availability of IN.PACT Falcon underscores our mission to provide physicians with the option of using drug eluting balloons for specific clinical indications throughout the coronary and peripheral anatomy. The launch of IN.PACT Falcon, our second drug eluting balloon platform, aligns with our strategy to leverage FreePac on all of our major balloon platforms."

"The drug-eluting balloon concept has already shown its potential to reduce re-intervention rates for patients with coronary atherosclerosis in clinical trials in a selected patient population," commented Prof. Scheller and Prof. Speck "Therefore the launch of efficacious matrix coatings on modern coronary balloon catheters by renowned medical device manufacturers is a major milestone in the development of appropriate ways to treat coronary atherosclerosis. It is also an essential precondition to incorporate clinical practice as the driving force for further improvements."

Prof. Eberhard Grube, Chief, Department of Cardiology/Angiology at the Heart Center, Siegburg, Germany, commented, "Combining world-class PTCA balloon catheter technology with local drug administration is a fascinating new concept for the treatment of certain coronary lesions such as In-Stent Restenosis (ISR), Bifurcations, Small Vessel Disease (SVD) and potentially other lesions where conventional balloons, stents and even drug eluting stents may not be ideal. A drug eluting balloon such as the IN.PACT Falcon that elutes a known and effective drug such as Paclitaxel holds much promise as an effective treatment option for patients."

In addition to IN.PACT Falcon paclitaxel-eluting balloon, Invatec recently launched IN.PACT™ Amphirion, its first drug-eluting balloon designed specifically for the treatment of atherosclerosis in arteries located below the knee.

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 a complete line of product families focusing on interventional peripheral, coronary and neuro products, which 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 1,000 employees.

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Invatec