Invatec S.r.l. announced that it will be completing the study of IN.PACT Amphirion Paclitaxel Eluting Balloon Catheter by December 2015.
IN.PACT Amphirion is a drug-eluting catheter that is designed to treat atherosclerosis in arteries which are located below the knee. IN.PACT features FreePac, which is a coating that frees and separates paclitaxel molecules and facilitates their absorption into the wall of the artery. It is specially tuned for Extremities Extreme Angioplasty (E.E.A.) that combines special shaft and balloon technologies. It has a 120 mm long balloon which is combined with 0.017 entry profile. IN.PACT Amphirion enables the treatment of diffuse lesions till the very distal foot arteries (e.g. pedal and plantar arteries).
The study is a prospective, multi-center, randomized (2:1) trial of symptomatic patients with critical limb ischemia (CLI) secondary to atherosclerotic lesions (stenotic or occluded) of the infrapopliteal vessels. Patients will undergo a percutaneous transluminal endovascular procedure with either the IN.PACT Amphirion drug eluting balloon or with a standard PTA balloon. Patients will be followed with pre-study, post-study, and follow-up evaluations.