www.fdanews.com/articles/113468-medtronic-launches-trial-for-self-expanding-stent
Medtronic Launches Trial for Self-Expanding Stent
January 5, 2009
Medtronic has begun enrolling patients in a clinical trial evaluating its self-expanding Complete SE stent for the treatment of peripheral arterial disease in the superficial femoral artery. Approved by the FDA under an investigational device exemption, the multicenter, single-arm trial will enroll 178 subjects at 30 international sites. The study has primary endpoints of major adverse events and patency of the stent at 12 months, the company said.