Cook Incorporated has filed for CE Mark approval to market the paclitaxel-eluting version of its popular V Flex Plus PTX Coronary Stent in the European Community. The filing makes Cook the first company to submit for regulatory approval anywhere in the world to market a paclitaxel-eluting coronary stent to combat restenosis.
"This milestone reinforces Cook's position as a world leader in bringing innovative technology like our new generation of paclitaxel-eluting stents to the benefit of coronary disease patients," said Kem Hawkins, president, Cook Group Incorporated. With timely CE Mark approval, Cook could begin selling its first drug-eluting coronary stents in Europe during the second quarter of this year, Hawkins predicted.
The filing is based on the results of Cook's highly successful European-based ELUTES clinical trial, which demonstrated a binary restenosis rate of just 3.1 percent due to paclitaxel's cytostatic mechanism of action in inhibiting neointimal hyperplasia.
In 1993, Cook Incorporated introduced the first commercially available coronary stents to the United States. These tiny wire scaffold-like devices, which became the most successful innovation in interventional cardiology of the 1990s, are inserted inside blocked sections of coronary arteries and expanded into place using a balloon catheter in a procedure called an angioplasty. One drawback to their success in maintaining blood flow through the affected artery, however, is that in approximately 20-25 percent of cases, a new blockage develops at the site of the angioplasty due to scar tissue growth and inflammation, a condition referred to as restenosis.
Paclitaxel acts to prevent excessive cell regrowth at the site of the angioplasty, which human clinical research has shown may reduce or eliminate restenosis. Cook's polymer-free, paclitaxel-eluting coronary stents are investigational devices not approved for sale in the U.S. at this time.