A Medical Device Daily

Medtronic (Minneapolis) reported the first enrollment in the company's FDA-approved clinical trial of its self-expanding (SE) Complete SE stent for the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA).

"Medtronic's clinical research program for peripheral arterial disease demonstrates a strong commitment to helping physicians and their patients," said the study's principal investigator, John Laird, MD, of the Vascular Center at the University of California, Davis. "Through three clinical trials currently underway, Medtronic is partnering with physicians worldwide to evaluate the safety and efficacy of its stents in the treatment of PAD."

PAD patients have a two- to six-fold increase in cardiovascular mortality and a significantly increased risk of amputation, disability and diminished quality of life, the PAD Coalition reports.

Approved by the FDA under an IDE, the SFA study is a prospective, multicenter, single-arm trial planned to enroll 178 subjects at up to 30 sites globally. Enrolling patients with symptomatic PAD in the SFA, the study has primary endpoints of major adverse events and patency of the stent at 12 months.