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Boston Scientific announced the was 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/S0140-6736[18]32262-1).
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.
Boston Scientific announced the was 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/S0140-6736[18]32262-1).
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.
Boston Scientific announced the was 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/S0140-6736[18]32262-1).
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.