Medtronic Receives European Approval for Drug-eluting Stent

Minneapolis-based Medtronic said it has received a CE Mark for its Endeavor drug-eluting stent, signaling a significant development in the fast-growing coated-stent segment. It brings the number of competitors in the segment to three following earlier approvals for stents offered by New Brunswick, NJ-based Johnson & Johnson and Natick, MA-based Boston Scientific.

The approval allows Medtronic, which is several years behind the two competitors, to market Endeavor and the Rapid Exchange Delivery System to all 25 European Union Countries. It is also perhaps a prelude to Medtronic entering the multi-billion-dollar U.S. coated stent market.

“We are very pleased to provide physicians and patients with Medtronic’s high-performance Endeavor drug-eluting stent system,” said Scott Ward, president of Medtronic Vascular. “Physicians will now have a broader choice among the drug-eluting stents that are available to treat their patients. We believe the Endeavor system offers a powerful combination of deliverability, efficacy and safety that is unmatched by any other commercially available stent.”

Medtronic said the company has an ample supply of Endeavor systems to support an aggressive global rollout. In fact, the company said it plans to conduct a simultaneous worldwide launch in approximately 40 countries outside the U.S.