Boston Scientific (BSX) Gets FDA Approval for Epic Vascular Self-Expanding Stent System
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Boston Scientific Corporation (NYSE: BSX) 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 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 6F 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 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 6F 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.
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