Medtronic seeks FDA approval to use the Complete SE stent in a femoral artery. Last year it was OK’d for use in iliac arteries.

., Medtronic

Legs: A new use for Medtronic stent?

  • Article by: JAMES WALSH
  • Star Tribune
  • February 8, 2012 - 8:37 PM

Considering that the use of stents in the treatment of patients with blocked blood vessels in the legs is a growing market -- an estimated 8 million Americans suffer from peripheral arterial disease (PAD) -- Medtronic on Wednesday trumpeted the results of its Complete SE vascular stent study.

More than 90 percent of patients who received the Complete SE stent in the superficial femoral artery did not need any follow-up procedures after a year.

The Complete SE stent last year received U.S. Food and Drug Administration approval for use in the treatment of PAD in iliac arteries, which run through the pelvis. Now, Medtronic is hoping for 2012 FDA approval for the stent's use in the superficial femoral artery, which runs under the skin of the upper leg and supplies blood from the thigh to the toes.

Fridley-based Medtronic is the world's largest medical device manufacturer and the company has high hopes for its Complete SE stent, a device that props open arteries clogged with fatty deposits called plaque, allowing for better blood flow.

The company's core cardiac rhythm management business, including pacemakers and implanted cardioinverter devices, has been slowing in recent years. In response, Medtronic and competitors like Boston Scientific Corp. and St. Jude Medical Inc., based in Little Canada, are pushing into higher growth markets, including neurovascular conditions -- blood clots in the brain -- and vascular diseases below a patient's waist.

That includes peripheral arterial disease.

PAD in the superficial femoral artery can result in leg pain while walking and, if left untreated, limb loss. It is often treated by having the patient make lifestyle changes and by taking medicines. They can also have endovascular or surgical procedures to open clogged blood vessels.

A self-expanding stent

Doctors often will open a clogged artery with angioplasty, the use of an expandable balloon to open the blood vessel. But that may have to be repeated if plaque builds up and the artery becomes blocked again -- called restenosis. Metal stents are used to keep the vessel open and can reduce the chance of restenosis.

The Complete ES stent is self-expanding, meaning it expands to fit the walls of the blood vessel. According to Medtronic, only 9.4 percent of the 196 people who went through the Complete SE clinical trial needed another procedure to open the superficial femoral artery. The trial was conducted at 28 sites in the U.S. and Europe. None were in Minnesota.

"The strong performance of the Complete SE vascular stent in this rigorously conducted clinical trial is encouraging," said Dr. John Laird of the University of California-Davis Medical Center, one of the principal investigators of the study.

James Walsh • 612-673-7428

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