Date: 9/7/2010

Cardiac Research offers new Option in Treatment of PAD

The SUPERA™ stent, an investigational device with exceptional strength and flexibility is available through a study on PAD being conducted at Community Hospital.

New technology to treat peripheral arterial disease (PAD) may offer longer-lasting relief from this painful, debilitating condition of the lower leg arteries. Community Hospital is the first in the region to participate in a related landmark study, called the SUPERB study, to add another weapon to the treatment options used in the fight against PAD.

“The SUPERA™ stent, an investigational device may offer an exciting advancement in technology available to treat PAD,” said Prakash Makam, M.D., medical director of cardiovascular research at Community Healthcare System and principal investigator of the trial. “This unique stent has exceptional strength and flexibility for use in difficult to treat areas, such as vessels in the lower thigh and behind the knee.”

Peripheral arterial disease (PAD) occurs when the arteries in the legs become narrowed or blocked by plaque. Blockage can result in critical leg ischemia, a condition where not enough blood is being delivered to the leg to keep the tissue alive. According to the American Heart Association, this condition affects approximately 8 to 12 million Americans. With only about 25 percent of PAD patients undergoing treatment, it is a disease that is largely under-diagnosed and under-treated. If left untreated, PAD can lead to severe pain, limited physical mobility, life-threatening non-healing leg ulcers, and amputation.

Stents have been used for decades to open diseased arteries. Stents offer a less invasive alternative to surgery for some conditions, which could result in a less complications and faster recovery. Problems sometimes occur with current slotted-tube stent technology including, stent fracture, and insufficient strength and flexibility resulting in kinking of the stent in the vessel.

The SUPERA™ stent, with its unique, super-elastic interwoven design, offers unparalleled strength, flexibility, durability and conformability over the traditional slotted tube stent technology. In engineering bench tests, the SUPERA® stent has shown to have a minimum of four times the radial strength and 360% stronger crush resistance than other slotted tube self-expanding stents.

The clinical trial, called SUPERB (Comparison of the SUPERA™ PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery), is a prospective, single-arm trial of 258 patients at up to 40 U.S. sites. It is nationally led by co-principal investigators Kenneth Rosenfield, M.D., section head for Vascular Medicine and Intervention at Massachusetts General Hospital, Boston, and Lawrence A. Garcia, M.D., chief, section Interventional Cardiology and associate director of Vascular Medicine at Boston’s Caritas St. Elizabeth Medical Center, where the first patient was treated.

The objective of the trial is to demonstrate the safety and effectiveness of the SUPERA™ stent in the treatment of obstructive arterial disease in the femoral artery of the lower leg. Success will be determined primarily by examining if the vessel remains open at 12 months after the procedure is performed. This is measured by simple blood pressure measurements in the leg and using sound waves that give a picture of the inside of the blood vessel without pain or surgery.

For more information about the cardiovascular research trials available through the hospitals of Community Healthcare System, visit our web site at and Clinical Trials.