Medtronic, Inc. (MDT) declared its receipt of the U.S. Food and Drug Administration (:FDA) approval for the Complete SE (self-expanding) vascular stent. The approval permits the use of the vascular stent in the lower extremities of the body, specifically, the superficial femoral artery (:SFA) and proximal popliteal artery (PPA) that carry blood through the upper legs.
The device had been earlier approved by the FDA for use in the iliac arteries, which perfuse the pelvis. It also boasts of the CE (Conformité Européene) mark for iliac, SFA and PPA indications.
Peripheral artery disease narrows blood vessels, due to the build up of plaque, resulting in reduced blood supply to the body, particularly the limbs. The condition can worsen to claudication and without proper treatment, it can also aggravate to critical limb ischemia, a condition which often leads to amputation and premature death.
Peripheral artery disease occurs mostly in people who indulge in smoking, or those suffering from diabetes, obesity, high blood pressure, and high cholesterol. Advanced age and heredity also pose as potential risks.
Stents are metallic scaffolds that improve blood flow by expanding the interior diameter of narrowed arteries. These tubular devices can be implanted through a minimally invasive procedure, with catheters being used to access the arterial segment that requires treatment.
The FDA approval was made after careful evaluation of an independently single-arm, multicenter trial, conducted for complete SE SFA study. It comprised of 196 patients spread across 28 sites throughout the United States and Europe. The study showed a clinically-driven target lesion revascularization (repeat procedure) rate of 8.4% at 12 months. The result ranks among the best performances in clinical trials of contemporary self-expanding peripheral stents for the treatment of SFA/PPA lesions.
Moreover, no in-hospital major adverse events (:MAE) among study patients have been found, while the total MAE rate stood at 11% at 12 months. The Kaplan-Meier estimate of primary patency for 360 days was reported to be 90.9% and at the time of the last duplex ultrasound assessment, for 553 days with primary patency estimated to be at 72.5%. No stent fractures occurred throughout the 12 months.
The patient population involved in the study was a challenging mix (45% of the patients suffered from diabetes, and 67% were diagnosed with a Rutherford classification of 3 or higher at baseline). Moreover, 50% of the treated lesions were located in the distal segment of the artery, and 91% of them were moderately or highly calcified.
Statistics substantiated remarkable improvements mainly in the clinical and functional effectiveness of the vascular stem. The study demonstrated that more than 80% of the patients achieved the desirable Rutherford classification of 0 or 1, for 30 days. The benefit stayed for 6-12 months of follow-up. Walking assessment measures for 12 months,showed improvement in impairment at 37%, distance at 32%, speed at 22% and stair climbing at 23% respectively.
Additionally, 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.
The Complete SE vascular stent is regarded as one of the most convenient and easy to use devices available in the industry. Healthcare experts have welcomed the FDA approval of the device as they consider it highly effective, based on the compelling clinical results derived from the study.
Currently, MDT carries a Zacks Rank #3 (Hold). Other medical products stocks that are worth a look include Alere Inc. (ALR), carrying a Zacks Rank #1 (Strong Buy) and Boston Scientific Corp. (BSX) and Advaxis, Inc. (ADXS), each carrying a Zacks Rank #2 (Buy).