Medtronic completes “important” stent study enrolment

Medtronic has announced it has completed enrolment for its ENDEAVOR IV clinical study, which could end with the Endeavor drug-eluting coronary stent being submitted for approval to the FDA.

The medical equipment company says it is compiling an amount of clinical data that will make the Endeavor stent the subject of the most rigorous examination of any drug-eluting stent before regulatory approval.

The trials are designed to provide analysis of safety and efficacy in over 2,000 patients who have used the new stent in the last 42 months.

Scott Ward, president of Medtronic’s vascular business, said: “Completion of patient enrolment in these three trials is a tremendous achievement for the Endeavor clinical programme.”

“Along with the data from our previous Endeavor trials, the results of the ENDEAVOR IV study will provide a very comprehensive picture of Endeavor’s clinical performance.”

Dr Martin B Leon, a co-principal study investigator, said the latest study would have more emphasis on clinical rather than angiographic results, allowing Medtronic and regulators to compare the product’s effectiveness with the market leaders.

Dr David E Kandzari, another of the co-principal study investigators, added that the study could alter doctors’ stent selection patterns and preferences.

Medtronic employs 30,000 members of staff around the world and provides medical equipment for 2.5 million patients every year. Its UK headquarters are based in Watford, where it employs over 200 people.

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