Angiotech Pharmaceuticals, Inc., a global specialty pharmaceutical and medical device company, reported that its corporate partner, Boston Scientific Corporation, has received US Food and Drug Administration (FDA) approval to market its Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System.
The Taxus Express Atom Stent is a highly deliverable drug-eluting stent (DES) specifically designed for treating small coronary vessels. It is the only DES approved by the FDA for use in vessels as small as 2.25 mm in diameter. BSC plans to launch the product immediately.
"The Taxus Express Atom Stent will provide better options for US patients with coronary artery disease in small vessels," said Gregg Stone, M.D., chairman of the Cardiovascular Research Foundation and Professor of Medicine at Columbia University Medical Center, and Principal Investigator of the Taxus IV and V clinical trials. "This is a welcome addition to the range of available drug-eluting stents, since patients with small vessels who are currently treated with bare-metal stents experience high rates of restenosis. In the Taxus V clinical trial, the Taxus Express Atom Stent significantly reduced the chance of restenosis and the need for repeat procedures compared to bare-metal stents, in patients with small vessel disease."
"We congratulate Boston Scientific on further expanding the paclitaxel DES portfolio to help interventional cardiologists address the unmet needs of patients suffering from small vessel disease," said Dr. William Hunter, president and CEO of Angiotech. "We believe this approval reflects the progress Boston Scientific is making towards resolving the issues outlined two years ago in the Corporate Warning Letter," he added.
Currently the leading drug-eluting stents worldwide, Taxus stent systems have been evaluated by the industry's most extensive randomized, controlled clinical trial program, as well as studied in more than 35,000 real-world patients enrolled in post-approval registries. To date, approximately 4.6 million Taxus stents have been implanted worldwide.
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury.