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Medtronic Stent for Narrowed Leg Arteries: 90% Freedom from Reinterventions at One Year
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Medtronic Complete SE Vascular Stent
Medtronic Complete SE Vascular Stent
February 8, 2012 -- Today Medtronic announced the one-year results of the Complete SE SFA study, a prospective, multicenter, single-arm trial designed to evaluate the safety and efficacy of the Complete SE vascular stent system in the treatment of de novo and/or restenotic lesions or occlusions in the superficial femoral artery (SFA), including the proximal popliteal artery (PPA). Approved by the FDA under an investigational device exemption (IDE), the study enrolled 196 patients with symptomatic, ischemic PAD and completed enrollment in August 2010.

Results: 90% Did Not Require Reintervention
The study results were presented over the past couple of weeks at this year's International Symposium on Endovascular Therapy (ISET) in Miami and the Leipzig Interventional Course (LINC) in Germany. The bottom line results were a primary patency rate of 73.1 percent, a major adverse event rate of 11.0 percent and a target lesion revascularization (TLR) rate of 9.4 percent at 12 months of patient follow-up. The low TLR rate, which measures symptom-driven reintervention, is significant because in peripheral (leg) blockages, lesions tend to be longer and older than those in the coronary, due to the fact that these narrowings are often asymptomatic, until they have become critical. Restenosis and reintervention has long been one of the biggest problems in the treatment of PAD.

It is estimated that peripheral artery disease (PAD) of the lower extremities, including the SFA, affects approximately 8 million people in the United States each year, although many patients are unaware of their condition or its consequences. 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 principal investigators of the Complete SE SFA study are Dr. John R. Laird. Medical Director of of UC Davis Vascular Center in the United States and Prof. Dr. Dierk Scheinert of the University of Leipzig Heart Center in Germany. The following comments are from Medtronic's press release.

John R. Laird, MD
John R. Laird, MD

"The strong performance of the Complete SE vascular stent in this rigorously conducted clinical trial is encouraging," said Dr. Laird, who presented the results at this year's International Symposium on Endovascular Therapy (ISET) in Miami and the Leipzig Interventional Course (LINC) in Germany. "The investigators found the device easy to use in treating SFA lesions of varying complexity, which is indicative of clinical practice."

Study subjects showed statistically significant improvements in all measures of clinical and functional effectiveness, such as Rutherford Category, mean ABI/TBI, and Walking Assessment. These improvements were achieved despite the enrollment of patients with moderately or severely calcified lesions (91.0%), diabetes (45.4%), and a Rutherford Category rating of 3 or higher (66.8%) at baseline.

More than 80% of study subjects had achieved a Rutherford Category value of 0 or 1, the favorable end of the 06 scale, at 30 days, and that benefit persisted through six months and one year of follow-up. Treatment with the Complete SE stent also resulted in highly significant positive shifts in mean ABI/TBI scores at six and 12 months, with more than 60% of study subjects improving by at least 0.15 over 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 Complete SE stent was approved by the FDA in April 2010 for use in the iliac arteries. Based on the results of this study, Medtronic plans to seek FDA approval for an expanded indication for use in the superficial femoral artery. Medtronic is also moving forward with a completely different technology, the drug-eluting balloon (DEB) for use in the peripheral vessels, including the narrower arteries below-the-knee.

Reported by Burt Cohen, February 8, 2012