Boston Scientific Corporation announced that it has received approval from the US Food and Drug Administration (FDA) to market its Taxus Express2 paclitaxel-eluting coronary stent system. The company plans to launch the product in the US immediately, and it has ample inventory in all sizes. The company launched the Taxus system in Europe and other international markets in February of 2003 and is the leader in those markets today.
"This approval is a breakthrough event for the treatment of cardiovascular disease in the United States," said Jim Tobin, CEO of Boston Scientific. "Broad, consistent clinical data and extensive real-world experience have clearly demonstrated that polymer-based delivery of paclitaxel is a safe and effective therapy that dramatically reduces restenosis. These attributes are complemented by the outstanding deliverability of the Taxus stent system. The approval of the Taxus system makes this revolutionary new therapy commercially available for the first time in the US."
"The approval of the Taxus system marks an important opportunity for clinicians in the US," said Gregg Stone, vice chairman of the Cardiovascular Research Foundation at the Lenox Hill Heart and Vascular Institute in New York, and Principal Investigator of the Taxus IV clinical trial. "In paclitaxel, we now have a multi-functional drug that is safe and highly effective. The Taxus system has shown impressive results across a wide range of patients. Its performance has been particularly impressive in challenging cases such as patients with diabetes, small vessels and long lesions."
"The Taxus system is a welcome new ally in the fight against cardiovascular disease," said Stephen Ellis, director of the Sones Cardiac Catheterization Laboratories at the Cleveland Clinic, and the co-principal investigator of the Taxus IV trial. "It offers a well-regarded drug in combination with a delivery system that is exceptionally flexible and conformable."
The Taxus product will use the Express2 coronary stent on the Maverick balloon catheter as its platform. Together, they form the Express2 coronary stent system, which is known for its excellent deliverability and conformability.