MEDTRONIC GIVEN EU APPROVAL FOR NEW STENT
European regulators have given medical devicemaker Medtronic approval to sell its Endeavor drug-eluting stent (DES) system in the European Union. The drug-coated device is designed to open patients' clogged arteries during angioplasty procedures.
Medtronic plans to immediately conduct an aggressive worldwide launch of Endeavor in 40 countries across Europe, the Middle East and Asia.The Endeavor stent system is not currently available in the U.S., where Boston Scientific and Johnson & Johnson are currently the only players in the DES field. Medtronic is continuing its U.S. clinical trials of Endeavor, and it plans to submit what it considers "key trial data" to the FDA by the middle of next year. Medtronic said it does not expect to have Endeavor in the U.S. market until 2007.
The Endeavor drug-eluting coronary stent system combines Medtronic's Driver cobalt alloy bare-metal stent with a drug and polymer licensed from Abbott Laboratories.
The cobalt alloy, Medtronic said, is stronger than stainless steel, making possible the creation of thinner struts without decreasing radial strength. The material is denser than stainless steel, allowing it to maintain good radiopacity, the company said.