The FDA approval is based on findings from the IMPERIAL trial
The Food and Drug Administration (FDA) has approved the Eluvia Drug-Eluting Vascular Stent System (Boston Scientific) for the treatment of peripheral artery disease.
The Eluvia stent is designed to release paclitaxel for a 1-year time frame to prevent tissue regrowth that might otherwise block the stented artery. The approval was based on findings from the IMPERIAL trial, the first superficial femoral artery head-to-head drug-eluting stent trial evaluating the safety and efficacy of Eluvia vs Zilver PTX in 465 patients across 64 sites.
Results showed that patients treated with the Eluvia stent (N=309) experienced a significantly greater 12-month primary patency of 88.5%, compared with 79.5% in patients treated with Zilver PTX (N=156) (P=.0119). In addition, 95.1% of Eluvia patients were free from major adverse events at 12 months vs 91.0% of Zilver PTX patients. Target lesion revascularization (TLR) rate was also lower in the in the Eluvia group at 4.5% compared with 9.0% for the Zilver PTX group.
"The Eluvia stent is a breakthrough therapy that marks a significant step forward in the treatment of peripheral artery disease, and now with its approval and commercial availability, it has the potential to make an immediate impact on the quality and value of care that physicians can provide to their patients," said William Gray, MD, system chief, Division of Cardiovascular Diseases and president, Lankenau Heart Institute at Main Line Health in Wynnewood, Pennsylvania, and co-principal investigator of the IMPERIAL trial.