Technology | May 23, 2012

FDA Clears Boston Scientific’s Epic Self-Expanding Peripheral Stent

May 23, 2012 - Boston Scientific Corp. announces U.S. Food and Drug Administration approval and market launch of the Epic Vascular Self-Expanding Stent System. The Epic Stent is designed to open blocked arteries in patients with iliac artery stenosis, a form of peripheral vascular disease associated with severe leg pain caused by insufficient blood flow.

"The Epic stent system demonstrates an excellent combination of flexibility, radial force and deployment accuracy - all important attributes when treating challenging atherosclerotic lesions in the iliac arteries," said Thomas Shimshak, M.D., medical director at Wheaton Franciscan Heart Care in Racine, Wis. "The comprehensive stent size matrix should also help meet a variety of clinical requirements when treating iliac arterial disease with no compromise in deliverability or stent performance."

The Epic stent is a self-expanding Nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. It employs an innovative Tandem Architecture, which is engineered to provide excellent stent flexibility while maintaining predictable radial force characteristics and fracture resistance. The Epic stent employs distal and proximal radiopaque markers and all stent sizes are compatible with 6 French sheaths. The stent delivery system is offered in two shaft lengths (75 cm and 120 cm) for all sizes and is compatible with 0.035" guidewires.

In January, Boston Scientific announced that the ORION trial met its primary clinical endpoint. The Epic vascular stent system demonstrated a low nine-month major adverse events (MAE) rate of 3.4 percent in the intent-to-treat population, which was significantly lower than the pre-specified performance goal of 17 percent (p<0.001) based on historical published outcomes for iliac stenting.

"The Epic stent is another example of our commitment to innovation in treating peripheral vascular disease, a growing worldwide health concern," said Jeff Mirviss, president of the Boston Scientific Peripheral Interventions Division. "This next-generation stent expands our growing peripheral interventions portfolio, complementing the leading Express LD balloon-expandable iliac stent, and offering physicians a versatile new option to treat patients with challenging lesions in the iliac arteries."

Iliac stenosis (narrowing) occurs when plaque accumulates within the arteries that supply blood to the legs, which can lead to poor blood flow, claudication (leg pain) and other complications. The disease can be treated with medication, surgery or angioplasty.

The Epic vascular self-expanding stent system received CE mark approval and was launched in Europe and other international markets in 2009.

For more information: www.bostonscientific.com

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