New Treatment Options In The U.S.

John Mitchell is an active guy. He plays basketball and jogs regularly, lifts weights and walks an average of three to four miles every day at his job in the Dietary department at University Hospitals Case Medical Center in Cleveland, Ohio, where he has worked for more than 20 years. When not working, John, 58, spends as much time as he can with his wife, children and granddaughter.

So when John began feeling pain in his right leg every morning as he walked from his car to his job at the hospital, he assumed it was due to strain from working and being tired. “I thought I’d just been working too hard, so I put off having it checked out,” he remembers.

But over several months in 2011, he began to find walking more painful, and he had to stop frequently to rest. “I would walk halfway from the parking lot to the hospital and would have to stop and catch my breath because of the pain in my leg,” he says. The pain eventually impacted his daily activities and forced him to give up playing basketball and jogging.

John, who was being treated by his cardiologist for a number of conditions, including coronary artery disease and diabetes, told his cardiologist about the pain, and he was referred to Dr. Sahil Parikh, a cardiologist and assistant Professor of medicine, University Hospitals Case Medical Center Harrington Heart & Vascular Institute. Dr. Parikh diagnosed a blockage in a blood vessel in John’s leg—the result of peripheral artery disease (PAD).

Peripheral artery disease occurs when fat and cholesterol buildup causes arteries outside of the heart to narrow, which reduces blood flow to parts of the body, most commonly the legs. The disease can cause leg pain, in addition to increasing the risk of heart attack or stroke.1 PAD can be successfully treated through various methods, including diet, exercise and medications. Difficult cases may require angioplasty, stents (tiny metal tubes) or surgery.

When exercise and diet modifications didn’t lessen John’s leg pain, Dr. Parikh determined that he would be a good candidate for a stent that was being evaluated in a clinical trial in the U.S. for treatment of PAD. Dr. Parikh, who is a clinical investigator in the SUPERB trial, treated the blockage in John’s leg with Abbott’s Supera® Peripheral Stent System, and within a week, John says, he had resumed his daily activities and was back on the job. Within a month, he was once again walking, jogging and playing basketball.

“John’s result has been very good, as shown clinically and through follow-up ultrasound testing,” says Dr. Parikh. “His symptoms have greatly improved, which is our goal, and he is able to return to his normal activities.”

With the U.S. FDA approval of Supera Peripheral Stent System for the treatment of blockages in the upper leg due to PAD, doctors in the U.S. now have an additional treatment option for patients with PAD. The Supera stent is approved to treat blockages in the superficial femoral artery (SFA), a blood vessel in the thigh, and the proximal popliteal artery, a blood vessel above the knee, caused by PAD.

The Supera stent is an important advancement for many people with PAD. It helps to reduce their leg pain while walking, and helps them resume their daily activities.2 Treating blockages in the leg presents unique challenges due to the leg’s frequent movement and range of motion as people walk, sit or stand.

Designed to mimic, rather than resist, the artery’s natural movement, the Supera stent features a unique, proprietary interwoven wire technology that restores blood flow to the treated area, while offering strength and flexibility—important qualities when treating vessels in the leg. Compared to other nitinol stents used to treat blockages in the upper leg, the Supera stent is more flexible, stronger and resistant to kinks or fracture under vigorous movement.3

“We have worked for many years to optimize stent designs to meet the tough design requirements of the arteries in the upper leg,” says Björn Svensson, Director, Product Development, Abbott Vascular. “With the Supera stent, we have brought forward a technology that has the perfect balance between strength and flexibility.”

“The interwoven, braided wire structure of the Supera stent has been engineered to uniformly distribute stress throughout the length of the stent, making it highly durable and resilient,” says Sepehr Fariabi, Ph.D., Director, Research and Development and Process Engineering, Abbott Vascular.

For John Mitchell, treatment with the Supera stent means he can continue to exercise every day, and can do the things he loves. “After treatment, I felt much better,” he says. “Everything turned out great.”

Click here to learn more about PAD and the Supera stent. (Fact Sheet)

In addition to the U.S., Supera also is sold in Europe, Australia, New Zealand, Southeast Asia and Hong Kong for treating blocked blood vessels caused by PAD.

Additional information about the Supera Peripheral Stent System, including important safety information, is available here.

1. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart Disease and Stroke Statistics—2011 Update: A report from the American Heart Association. Circulation 2011; http://circ.ahajournals.org/content/123/4/e18.

2. Supera® Peripheral Stent System Instructions for Use. Data on file at Abbott Vascular.

3. Data on file at Abbott Vascular.