The US Food and Drug Administration (FDA) has cleared Boston Scientific's Epic Vascular Self-Expanding Stent system.
The Epic system is a self-expanding Nitinol stent designed to open blocked arteries in patients with iliac artery stenosis.
The Epic Stent includes distal and proximal radiopaque markers and all stent sizes are compatible with 6F sheaths.
The Stent system is available in two shaft lengths (75 cm and 120 cm) for all sizes and is compatible with 0.035 guidewires.
Wheaton Franciscan Heart Care medical director Thomas Shimshak said, "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."
As announced on January 2012, Orion trial of the Epic System met its primary clinical endpoint which showed a low nine-month major adverse events rate of 3.4% in the intent-to-treat population.