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


May 23, 2012

Boston Scientific's Epic Vascular Self-Expanding Stent System 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 is designed with a combination of flexibility, radial force and deployment accuracy. A comprehensive stent size matrix also helps meet a variety of clinical requirements when treating iliac arterial disease.

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.

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. It was released in the U.S. market in May 2012.

For more information: www.bostonscientific.com