Minvasys’s Nile Pax DES System Approved in Europe for Bifurcation Treatment

December 16, 2009—Minvasys (Gennevilliers, France) announced that it has received CE Mark approval for its Nile Pax polymer-free drug-eluting stent system, which is indicated for coronary bifurcation treatment.

According to the company, the Nile Pax is a dedicated L605 cobalt-chromium alloy stent with a polymer-free abluminal paclitaxel coating, which avoids additional inflammation linked to the presence of polymer, and inhibits smooth muscular cell proliferation after stent implantation. The stent is mounted on two independent rapid exchange catheters. Minvasys stated that it will market the Nile Pax in Europe at the end of first quarter of 2010 and hopes to obtain product range extension approval by the end of the third quarter of 2010.

Minvasys has conducted international registries on the Nile CroCo bare-metal stent platform that has been CE Mark approved since 2005 and shortly will be closing a 100-patient clinical trial of the Nile Pax in de novo bifurcated lesions. Principal Investigator, Jean Fajadet, MD, will present preliminary results in May 2010 during the EuroPCR conference in Paris. This clinical trial will be followed by further investigations, notably intravascular ultrasound and optical coherence tomography imaging, or new indications thus far excluded from the scope of the current platform (left main trunk), the company stated.