Medtronic: Endeavour IV clinical trial meets primary endpoint

Medtronic has announced that its clinical trial of the Endeavour drug-eluting coronary stent has met its primary, non-inferiority endpoint.

The Endeavour IV clinical trial assessed the safety and efficacy of the Endeavour drug-eluting coronary stent when compared to the Taxus paclitaxel-eluting coronary stent available from Boston Scientific.

In the trial of 1,548 patients at 80 clinical centres, the Endeavour stent met its primary endpoint of target vessel failure – a term encompassing cardiac death, myocardial infarction and target vessel revascularisation – at nine months.

The company expressed plans to transmit the final clinical trial data from the Endeavour IV study at the annual conference for Transcatheter Cardiovascular Therapeutics in October this year, while the firm will also submit this data to regulatory bodies.

Scott Ward, president of cardiovascular business at Medtronic, said: “The Endeavour stent continues to demonstrate positive results for patients around the world.

“The Endeavour stent has produced excellent results across an extensive clinical program, with long-term clinical follow up extending to three and four years.”

He added that the company has amassed the most complete records of clinical study data produced for drug eluting stent application in the US, with its dossier covering over 4,100 patients.

Last month, Medtronic reported “excellent” results from the 12-month Valor study assessing its Talent thoracic stent graft system.