Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Medtronic has initiated the first investigational site in the US to participate in Protect, the company's global study comparing the Endeavor and Cypher drug-eluting stents on key safety metrics, including stent thrombosis – a rare but serious adverse event in which a blood clot forms inside the stent, with the potential to cause heart attack or death.
Subscribe to our email newsletter
Protect sites in the US will serve to provide the FDA with US-specific data on the post-market experience with the Endeavor stent. The US sites will enroll a minimum of 1,000 patients who receive Endeavor stents through Protect or, if necessary, through a nonrandomized continued-access arm.
Laura Mauri, chief scientific officer of the Harvard Clinical Research Institute in Boston, said: “This trial, including at least 1,000 in the US arm, will help further clarify the critical balance between safety and efficacy of drug-eluting stents in real-world practice.”