Invatec Receives CE Mark Approval for the IN.PACT Admiral Drug Eluting Balloon

Third IN.PACT Catheter Line Now Available in Europe, Targeting the Superficial Femoral Artery.

Invatec, a comprehensive innovator of interventional products, today announced the receipt of the CE Mark and the European launch of its IN.PACT™ Admiral paclitaxel-eluting PTA balloon catheter at the EuroPCR Congress 2009 in Barcelona, Spain. The IN.PACT Admiral is one of the first drug-eluting balloons designed specifically for the treatment of Peripheral Arterial Disease (PAD), including the Superficial Femoral Artery (SFA) and represents the third Invatec balloon catheter line to leverage their proprietary IN.PACT drug-elution technology platform.

“Interventional treatment of the superficial femoral artery (SFA) has always been among the least effective of all interventional vascular procedures in terms of long-term efficacy,” says Prof. Gunnar Tepe, Chief Physician of the department of Radiology from the Klinikum Rosenheim, Germany, and principal investigator of the IN.PACT THUNDER trial. “Initial experiences with a prototype drug eluting balloon have shown the potential to reduce restenosis and target lesion revascularization rates. The IN.PACT Admiral represents an important new device in our toolbox for more sustainable results when fighting Peripheral Arterial Disease. Going forward, the IN.PACT THUNDER trial will be performed to confirm the data acquired to date, assess effectiveness in longer SFA lesions, and provide a better understanding of the pharmacokinetics of DEB.”

Andrea Venturelli and Stefan Widensohler, the co-founders of Invatec commented: “With the launch of the IN.PACT Admiral, we become the only company in the world to market a Drug Eluting Balloon on three different balloon platforms, targeting three different anatomies: the coronaries, the vessels below the knee, and now with IN.PACT Admiral, the vessels above the knee. We will continue our heavy investment in this area, both technically and clinically, and expect to bring more Drug Eluting Balloon platforms to the market in the near future.

IN.PACT Admiral combines the currently marketed, performance leading Admiral line of PTA balloon catheters with Invatec’s proprietary IN.PACT technology platform and FreePac™ coating. FreePac is 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, Ph.D., Department of Radiology at Charité Mitte, Berlin and Bruno Scheller, M.D., University Hospital, Department of Internal Medicine, Homburg/Saar.

Source:  Invatec

Share your thoughts

Your email address will not be published. Required fields are marked *