Medtronic’s Complete ‘SE’ Vascular Stent sees FDA Expand Indications Down the Leg

Medtronic’s vascular business is one of its recent success stories, showing revenue growth above most other device areas in its portfolio. Now the company has announced U.S. FDA approval for its so-called Complete™ SE (self-expanding) vascular stent for use in the lower extremities. Complete SE was already approved for use in the Iliac arteries. Now they can add Superficial Femoral (SFA) and Proximal Popliteal (PPA) arteries to the label.

Background

Risk factors for peripheral artery disease (PAD) include smoking, diabetes, obesity, high blood pressure, high cholesterol, age (50 or older) and familial history. Typically characterized by an excessive buildup of plaque in the peripheral vessels, the condition can progress to claudication and, without treatment, to critical limb ischemia, which often leads to amputation and premature death.

Among treatments used to restore and maintain normal blood flow in patients with peripheral artery disease, are stents from a variety of manufacturers. One such is Medtronic’s Complete SE which incorporates a dual-deployment handle and a triaxial catheter. The company claims this provides physicians with exceptional deployment accuracy, while also minimizing unexpected stent jumping.

According to a press release, issued by Medtronic, the FDA’s approval of the new SFA and PPA indications was supported by the results of the Complete SE SFA study. This was an independently adjudicated single-arm, multicenter trial that enrolled 196 patients at 28 sites in the United States and Europe. The study showed a clinically-driven target lesion revascularization rate (or “need for re-do”) of only 8.4 percent at 12 months, which it says is among the best reported in clinical trials of contemporary self-expanding peripheral stents for the treatment of SFA/PPA lesions.

Find out more about the clinical results in the press release, here.

Physician comments

“The Complete SE vascular stent has demonstrated compelling clinical results in this study, which included a broad spectrum of patient and lesion types,” said primary investigator Dr. John Laird, medical director of the UC Davis Vascular Center near Sacramento. “It is also among the most deliverable and easy-to-use devices of its kind.”

Regulatory status

The Complete SE stent also carries the CE marking for iliac, SFA and PPA indications.

Source: Medtronic, Inc.