Date: 5/1/2009

Tiny Mesh Stent offers new lease on life for those with Peripheral Artery Disease

Wheatfield resident Larry Colgan is able to walk pain-free thanks to new technology and access to a key national research trial available through Community Hospital for the study of PAD.

Three months ago, 63-year old Larry Colgan of Wheatfield couldn’t walk at all without piercing pain in his right leg. But after a minimally invasive procedure at Community Hospital by Prakash Makam, M.D., medical director of cardiovascular research for Community Healthcare System, Colgan is pounding the pavement again at his job with a local auto dealer.

“Before the procedure, I couldn’t walk anywhere without throbbing pain,” said Colgan. “I put in a lot of miles walking on the job at Thomas Auto Group between seven dealerships in Illinois and Indiana. But after Dr. Makam put the stent in, it’s been fantastic. I’m able to walk anywhere — with no pain or limitations.”

Community Hospital was the first in the United States to perform an implant of the longest EverFlex Stent in the Superfical Femoral Artery as part of a key research trial evaluating new treatments for Peripheral Artery Disease or PAD, a painful, debilitating condition that limits blood flow to the limbs.

Cardiologist Prakash Makam, M.D., who serves as the lead investigator at Community Hospital, implanted a similar Protégé® EverFlex™ Stent in Colgan’s right leg as part of the DURABILITY II Study. Community Hospital is one of only about 30 hospitals in the country to participate in this clinical study.

“The EverFlex covers a significant lesion with a single stent without the need to overlap a second stent,” Makam said. “Overlapping stents can create opportunities for stent fracture, and the EverFlex provides the length necessary to treat the femoral artery with a single stent.”

Other features of the EverFlex stent include an open lattice design that provides flexibility and conforms and reinforces the femoral wall for added strength and durability.

To further evaluate the safety and effectiveness of the Protégé EverFlex stent, a small select group of hospitals are offering patient access to the DURABILITY II Study. The study compares the EverFlex stent outcomes to percutaneous transluminal angioplasty (PTA) performance goals in patients who have stenosis (blockages) in the superficial femoral artery (SFA). The SFA is a major artery that runs between the thigh and the knee, feeding smaller arteries that supply blood to the lower half of the leg.

According to the American Heart Association, PAD affects eight million Americans and is a significant cause of both amputation and death.

The Protégé EverFlex Stent is designed for use in the SFA, where PAD is often present. The DURABILITY II Study is the first of its kind study to explore single stent treatment of long lesions as well as long-term follow up on stent fracture. Stent fracture has been associated with the use of overlapped stents in past PAD treatment studies. The EverFlex stent’s long length and unique design allows for stenting of longer lesions with a single stent.

The DURABILITY II Study is the latest in a number of research trials that have been conducted at Community Hospital exploring new technologies and treatment options for PAD. Dr. Makam has served as the principal investigator in many of these trials, many of which have been lead by the VIVA Group, a group of leading experts in the field peripheral vascular disease who are helping to further the science of PAD.

For more information about the cardiovascular research trials available through the hospitals of Community Healthcare System, visit our web site at then click on Cardiovascular Research and clinical trials.