January 5, 2009 - Medtronic Inc. today announced 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).
According to the Peripheral Arterial Disease Coalition, PAD of the lower extremities affects approximately 8 million people in the U.S., although many patients are unaware of their condition or the seriousness of it. 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.
“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, M.D., 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.”
Approved by the FDA under an investigational device exemption (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 (MAEs) and patency of the stent at 12 months.
Enrollment in two other PAD studies to evaluate the treatment of iliac artery lesions with Medtronic stents also began in 2008:
- The Complete SE stent is currently being evaluated in an IDE-approved clinical trial for use in the treatment of iliac artery lesions in subjects with symptomatic and asymptomatic PAD. The Complete SE Iliac Registry is a non-randomized, prospective study designed to enroll 60 subjects. The primary study endpoints are MAEs at 30 days and nine months. With 12 U.S. sites participating, enrollment is nearly complete.
- Similarly, the balloon-expandable Assurant Cobalt stent is currently being evaluated in an IDE-approved clinical trial as a treatment for iliac artery lesions in subjects with symptomatic PAD. Initiated in October 2008, the study is a non-randomized, prospective, single-arm trial with an enrollment target of 123 subjects at 20 U.S. sites. The primary endpoint of the study is MAEs at nine months.
For more information: www.medtronic.com