The US Food and Drug Administration (FDA) has granted marketing approval for Boston Scientific's Epic vascular self-expanding stent system.
The Epic vascular system is a self-expanding nitinol stent 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 vascular stent leverages Tandem Architecture, which is engineered to provide stent flexibility while maintaining predictable radial force characteristics and fracture resistance.
Compatible with 6F sheaths, the Epic system utilises distal and proximal radiopaque markers and provides sustained vessel patency, improved visibility and accuracy during stent placement.
The approval follows the ORION trial, in which the Epic vascular stent system demonstrated a low nine-month major adverse events (MAE) rate of 3.4% in the intent-to-treat population, which was considerably lower than the pre-specified performance goal of 17%.
The Epic stent is available in two shaft lengths (75cm and 120cm) for all sizes and is compatible with 0.035 inch guidewires.
Wheaton Franciscan Heart Care, US, medical director Thomas Shimshak said the Epic stent demonstrates a combination of flexibility, radial force and deployment accuracy, all important attributes when treating challenging atherosclerotic lesions in the iliac arteries.
"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," Shimshak added.
Boston Scientific peripheral interventions division president, Jeff Mirviss, said the Epic stent expands the company's growing peripheral interventions portfolio, complementing the Express LD balloon-expandable iliac stent, and offering physicians a versatile new option to treat patients with challenging lesions in the iliac arteries.
In 2009, the European Commission approved the Epic vascular self-expanding stent system.
Image: The Epic vascular self-expanding stent from Boston Scientific has been cleared in the US. Photo courtesy of: Glitzy queen00.