One-Year Data From Medtronic's Complete SE SFA Study Presented

February 8, 2012—Medtronic, Inc. (Minneapolis, MN) announced the 1-year results of an international study of the Complete SE self-expanding vascular stent for the treatment of atherosclerosis in the superficial femoral artery (SFA). The data were presented in January at the International Symposium on Endovascular Therapies (ISET) in Miami Beach, Florida, and at the Leipzig Interventional Course (LINC) in Leipzig, Germany.

The results presented included that at 12-month follow-up, the Complete SE SFA study demonstrated a primary patency rate of 73.1%, a major adverse event rate of 11%, and a target lesion revascularization rate of 9.4%.

The Complete SE SFA study is a prospective, single-arm trial that enrolled 196 patients with a total of 213 lesions at 28 sites in the United States and Europe. The study evaluates the safety and efficacy of the Complete SE stent in treating lesions of the SFA, including the proximal popliteal artery (PPA). The primary endpoints assessed at 12 months were major adverse events for safety and primary patency for efficacy. All patients in the study were determined to have symptomatic, ischemic peripheral artery disease involving the SFA/PPA. The Principal Investigators of the study are John R. Laird, MD, and Prof. Dierk Scheinert, MD.


According to the data presented, patients in the study showed statistically significant improvements in all measures of clinical and functional effectiveness, such as Rutherford category, mean ankle-brachial index/toe-brachial index (ABI/TBI), and walking assessment. These improvements were achieved despite the enrollment of patients with moderately or severely calcified lesions (91%), diabetes (45.4%), and a Rutherford category rating of 3 or higher (66.8%) at baseline. 



More than 80% of the patients had achieved a Rutherford category value of 0 or 1 at 30 days, and that benefit persisted through 6 months and 1 year of follow-up. Treatment with the Complete SE stent also resulted in highly significant positive shifts in mean ABI/TBI scores at 6 and 12 months, with more than 60% of study patients improving by at least 0.15 during the follow-up period. On walking assessment measures, impairment improved by 36.8%, distance by 32.4%, speed by 21.8% and stair climbing by 23.3%.


“The strong performance of the Complete SE vascular stent in this rigorously conducted clinical trial is encouraging,” commented Dr. Laird, who presented the results at the 2012 ISET conference. “The investigators found the device easy to use in treating SFA lesions of varying complexity, which is indicative of clinical practice."

In the United States, the Complete SE device has Food and Drug Administration (FDA) approval for use in the iliac arteries and is commercially available for that indication, but is not cleared for use in the SFA. Medtronic plans to seek FDA approval for an SFA indication.