Boston Scientific Announces FDA Approval and Launch of Epic Vascular Stent for Iliac PAD

May 17, 2012—Boston Scientific Corporation (Natick, MA) announced US Food and Drug Administration approval and market launch of the Epic vascular self-expanding stent system for treatment of iliac artery stenosis. The Epic system received CE Mark approval and was launched in Europe and other international markets in 2009.

The Epic self-expanding nitinol stent is designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement, according to the company. The device employs the company's Tandem Architecture, which is engineered for 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-F sheaths. The stent delivery system is offered in shaft lengths of 75 cm and 120 cm for all sizes and is compatible with 0.035-inch guidewires.

In January, Boston Scientific announced that the Epic vascular stent system's ORION trial met its primary clinical endpoint, demonstrating a low 9-month major adverse event rate of 3.4% in the intent-to-treat population, which was significantly lower than the prespecified performance goal of 17% (P < .001) based on historical published outcomes for iliac stenting.

“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,” commented Thomas Shimshak, MD, Medical Director at Wheaton Franciscan Heart Care in Racine, Wisconsin, in a press release. ”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.”