CE mark for paclitaxel-eluting balloon

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Invatec have announced CE-certification of a new coronary balloon, the IN.PACT Falcon paclitaxel-eluting percutaneous transluminal coronary angioplasty 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 PhD, Charité Berlin, Germany, and Bruno Scheller MD, University Hospital, Homburg/Saar, Germany.


“We are extremely excited to commercialise 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 reintervention rates for patients with coronary atherosclerosis in clinical trials in a selected patient population,” commented Professor Scheller and Professor 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.”


Professor Eberhard Grube, the Heart Center, Siegburg, Germany, said: “Combining world-class percutaneous transluminal coronary angioplasty balloon catheter technology with local drug administration is a fascinating new concept for the treatment of certain coronary lesions such as in-stent restenosis, bifurcations, small vessel disease 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.”


Invatec

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