Boston, MA 09/25/2013 (wallstreetpr) – Medtronic, Inc. (NYSE: MDT) announced that the United States FDA has approved the Complete SE vascular stent that will be used in lower-extremities. This will specifically be used in the superficial femoral-artery and the proximal popliteal-artery. Both these arteries supply blood to the upper legs.
Previous approvals
Originally, this same device from Medtronic, Inc (NYSE:MDT) had received FDA approval for use in iliac arteries. These arteries supply blood to the pelvic area. This device also has the CE-mark for iliac, PPA and SFA indications. The approval from the Food Drug Administration for the PPA and SFa was supported by results from the Complete SE-SFA study.
This was an independently-adjudicated single arm, multi-center trial with 196 patient enrolments across 28 sites in Europe and the U.S. this study proved a clinically driven target-lesion revascularization rate of 8.4% at 12 months. This is amongst the best-performances in clinical-trials of similar self-expanding peripheral-stents used in the treatment of SFA/PPA lesions.
Other reports
In addition, there were none in-hospital MAE’samong study patients, and the total MAE-rate at 12-months was only 11.0percent. The Kaplan-Meier estimate for primary-patency at 360 days stood at 90.9%; at the point of last duplex-ultrasound assessment, at 553 days, the primary-patency stood at 72.5%. There were no stent fractures in 12 months.
Tuesday’s trading
In Tuesday’s trading session, Medtronic, Inc (NYSE:MDT) stock dropped by 0.61%. The shares had an opening price of $53.85 which climbed to an intraday high of $53.87 and dropped to a close of $53.43. Approximately 2.85 million shares were traded on Tuesday while an average volume of 4.53 million shares were traded over 30 days. The 52-week low of the shares was $40.28 and the 52-week high was $55.98. Medtronic, Inc (NYSE:MDT) has a market cap of $53.29 billion.
