Boston Scientific announced thewas presented at the Transcatheter Cardiovascular Therapeutics annual meeting in San Diego.
The Eluvia Drug-Eluting Vascular Stent System is designed to restore blood flow in the peripheral arteries above the knee – specifically, the superficial femoral artery and proximal popliteal artery, according to the company.
Lead investigator William A. Gray, MD, a cardiologist at the Lankenau Heart Institute, Wynnewood, Pa., presented the results of IMPERIAL at TCT 2018. The randomized, head-to-head trial compared the performance of Eluvia with the paclitaxel-eluting Zilver PTX, which at the time was the only drug-releasing stent approved in the United States for the indication. Patients had occlusive lesions of the superficial femoral and/or proximal popliteal arteries.
At 12 months, primary patency was 86.8% in the Eluvia group versus 81.5% among those randomized to Zilver PTX, meeting the threshold for noninferiority.
For the endpoint of target lesion revascularization, Eluvia was superior to Zilver PTX, with 4.5% and 9% of patients, respectively, requiring it (Lancet. 2018 Sep 22. doi: 10.1016/S0140-673632262-1).
According to Boston Scientific’s announcement of the approval, the drug-polymer combination used in the Eluvia stent offers sustained release of paclitaxel over 1 year to prevent tissue regrowth.
Eluvia was approved in Europe in early 2016.