Medtronic Stent Given Thumbs Up in Canada

Medtronic of Canada has received marketing approval from Health Canada’s Therapeutic Products Directorate for its Endeavor drug-eluting coronary stent system. The company expects to begin selling the stent in Canada by the end of the month. 

Research has shown that Endeavor stents provide consistent, sustained reduction in the need for repeat procedures compared with a bare-metal stent while maintaining an excellent safety profile, Medtronic said.
 
The company will provide annual updates on postmarket clinical registries and trials for a period of five years as a condition of the Canadian approval. These updates will include results from a proposed single-arm, post-approval study involving at least 5,000 patients.