FDA Approves SFA/PPA Indication for Medtronic's Complete SE Vascular Stent

September 24, 2013—Medtronic, Inc. (Minneapolis, MN) announced that the US Food and Drug Administration (FDA) has approved the company's Complete SE self-expanding vascular stent for use in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

The FDA approved the Complete SE in April 2010 for use in the iliac arteries. The device also has European CE Mark approval for iliac arteries and, as of January 2013, for SFA and PPA indications.

According to Medtronic, FDA approval of the new SFA and PPA indications was supported by the results of the Complete SE SFA study, an independently adjudicated single-arm, multicenter trial that enrolled 196 patients at 28 sites in the United States and Europe.

In the company's press release, Complete SE Primary Investigator, John R. Laird, MD, commented, “The Complete SE vascular stent has demonstrated compelling clinical results in this study, which included a broad spectrum of patient and lesion types. It is also among the most deliverable and easy-to-use devices of its kind.” Dr. Laird is Medical Director of the UC Davis Vascular Center in California.

The study showed a clinically driven target lesion revascularization rate of 8.4% at 12 months, which Medtronic stated is among the best performances in clinical trials of contemporary self-expanding peripheral stents for the treatment of SFA/PPA lesions.

Additionally, there were no in-hospital major adverse events (MAE) among study patients, and the total MAE rate at 12 months was 11%. The Kaplan-Meier estimate of primary patency at 360 days was 90.9%; at the time of the last duplex ultrasound assessment, at 553 days, primary patency was 72.5%. No stent fractures occurred through 12 months.

The company reported that the Complete SE SFA study also showed statistically significant improvements in multiple measures of clinical and functional effectiveness: more than 80% of the patients had achieved a Rutherford classification of 0 or 1 at 30 days, and that benefit persisted through 6 months and 1 year of follow-up; on walking assessment measures at 12 months, absolute improvement in impairment was 37%, distance was 32%, speed was 22%, and stair climbing was 23%; 65% of the patients showed an improvement of 0.15 or more on their ankle-brachial index (ABI) or toe-brachial index (TBI) scores over the 12-month follow-up period. The mean ABI/TBI score at 12 months was 0.9.

Medtronic noted that these outcomes were achieved in a challenging patient population: 45% of the patients had diabetes, and 67% had a Rutherford classification of 3 or higher at baseline; 50% of the treated lesions were located in the distal segment of the artery, and 91% were moderately or highly calcified.