Medtronic presents Endeavor clinical data synopsis

Medtronic has presented a summary of the clinical data relating to its Endeavor drug-eluting coronary stent.

This data – which will be submitted to the advisory panel of the US Food and Drug Administration (FDA) this week – involves 2,100 patients studies over four clinical trials.

The company will report that the Endeavor stent shows an enhanced reduction in restenosis sustained over time when compared to bare metal stents, with the drug-eluting device showing a unique long-term safety profile, exhibiting low rates of myocardial infarction, stent thrombosis and cardiac death.

Following the presentation, the advisory panel will make a decision regarding the recommendation of the stent to the FDA.

Scott Ward, president of the cardiovascular business of Medtronic, said: “The Endeavor clinical program has compiled a comprehensive set of data on the safety, efficacy and procedural success of the next-generation Endeavor stent.”

He added that the volume and period of the clinical data outmatches all previous information regarding a drug-eluting stent presented to an FDA advisory panel for approval.

In October 2006, Medtronic announced the initiation of the Protect study involving 8,000 patients, comparing the Endeavor stent to the Cypher sirolimuseluting stent from Johnson & Johnson.