Invatec Announces Product Milestones at Leipzig Meeting

January 29, 2010—Invatec (Roncadelle, Italy) announced that the first clinical results for the use of the In.Pact Amphirion paclitaxel-eluting balloon for complex critical limb ischemia (CLI) in below-the-knee vessels were presented at the LINC 2010: Leipzig Interventional Course meeting in Leipzig, Germany. Investigator Andrej Schmidt, MD, reported that preliminary results indicate a dramatic reduction in the restenosis rate with application of the device.

Dr. Schmidt commented, “In our experience, 69% of CLI patients with long lesions show restenosis after 3 months. The In.Pact Amphirion was able to bring this number down to 31%. Considering the mean lesion lengths of 17 cm and 58% rate of total occlusions before intervention, these results have the potential to change the way we treat complex CLI.”

Professor Dierk Scheinert, MD, principal investigator of the In.Pact Amphirion register, added, “It took us several years to develop adequate techniques to successfully reopen below-the-knee arteries, but we had no means of preventing restenosis for longer arterial segments. Drugeluting stents are only feasible in short lesions. The drugeluting balloon is the first method that brings down restenosis rates in those complex CLI cases. An interesting observation is also the nature of the restenosis; if it appears after treatment with the drug-eluting balloon, we see focal segments, not renarrowing along the total artery. This makes reintervention less complex.”

Invatec plans to proceed with its clinical trial program to provide further definitive proof that drug-eluting balloons can benefit patients with arterial disease in the coronaries, in hemodialysis shunts, and throughout the entire leg. The company has initiated several clinical trials to assess its In.Pact paclitaxel-eluting balloon line, which includes four different balloon platforms. Previous trials conducted on the superficial femoral artery and coronary arteries have shown outcomes favoring drug-eluting balloons, the company stated.

On January 27, Invatec announced the European launch of the Maris Plus self-expanding peripheral stent system in new 6-, 7-, and 8-mm diameters, appropriate for interventions involving the superficial femoral arteries. The 9-, 10-, and 12-mm diameters of the stent are already marketed for the iliac arteries. At the stent ends, the device's cell design allows interventionists to place several stents in series without stiffening the artery in the overlap region. The stent geometry creates an overlap region that allows two stents to act as one in the femoral artery and provides flexibility, fracture resistance, and tailored deployment, the company stated.