Arterial Remodeling Technologies said it won CE Mark approval in the European Union for its bioreabsorbable stent for treating coronary artery disease.
ART’s Pure Bioreabsorbable Scaffold is designed to relinquish its primary function within 3 months and be completely reabsorbed into implanted body after 24 months, the company said.
CE Mark approval came after 3 years of research on the device, ART said. In May 2012, the company won FDA approval for a 1st-in-man study of the stent.
"Receiving the CE Mark for our Pure Bioresorbable Scaffold is a significant milestone for ART as we continue to develop this technology for the treatment of coronary artery and peripheral vascular disease. We are very pleased with the clinical performance of the pure bioresorbable scaffold," CEO Machiel van der Leest said in prepared remarks.
In March, ART signed a deal with Terumo Corp. (TYO:4543) for exclusive use of the drug eluting bioreabsorbable stent for the treatment of coronary heart disease. All other indications are being developed by Vascular Bioresorbable Technologies, the company said in a press release.
Arterial stents are tubes inflated inside narrow blocked arteries to improve blood flow, and are typically made of metal. The 1st bioabsorbable stent to be approved in the European Union came from Abbott (NYSE:ABT) in 2011.
