FDA News

Peripheral DES receives FDA approval

William A. Gray

Boston Scientific announced that the FDA has approved its drug-eluting stent with a polymer coating for treatment of peripheral artery disease.

The device (Eluvia, Boston Scientific) is the second DES approved in the U.S. to treat PAD. The approval was based upon the results of the IMPERIAL trial, in which the Eluvia device was superior to the other device approved for the indication, a DES without a polymer coating (Zilver PTX, Cook Medical) in patency and target lesion revascularization at 12 months, according to a press release from Boston Scientific.

The IMPERIAL trial also showed that the Eluvia device was noninferior to the Zilver PTX device in major adverse events, and those assigned the Eluvia device had numerically lower rates of TLR and stent thrombosis than those assigned the Zilver PTX device.

According to the release, the Eluvia device releases paclitaxel for 1 year to prevent in-stent restenosis and other complications.

“In the IMPERIAL trial, the Eluvia stent demonstrated landmark vessel patency and freedom from target lesion revascularization rates, preventing more than 95% of patients from needing a reintervention after 1 year,” William A. Gray, MD, system chief of the division of cardiovascular diseases and president of Lankenau Heart Institute at Main Line Health in Wynnewood, Pennsylvania, who presented the IMPERIAL findings at TCT 2018, said in the release. “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.”

Disclosure: Gray reports that he is an adviser for Boston Scientific.

William A. Gray

Boston Scientific announced that the FDA has approved its drug-eluting stent with a polymer coating for treatment of peripheral artery disease.

The device (Eluvia, Boston Scientific) is the second DES approved in the U.S. to treat PAD. The approval was based upon the results of the IMPERIAL trial, in which the Eluvia device was superior to the other device approved for the indication, a DES without a polymer coating (Zilver PTX, Cook Medical) in patency and target lesion revascularization at 12 months, according to a press release from Boston Scientific.

The IMPERIAL trial also showed that the Eluvia device was noninferior to the Zilver PTX device in major adverse events, and those assigned the Eluvia device had numerically lower rates of TLR and stent thrombosis than those assigned the Zilver PTX device.

According to the release, the Eluvia device releases paclitaxel for 1 year to prevent in-stent restenosis and other complications.

“In the IMPERIAL trial, the Eluvia stent demonstrated landmark vessel patency and freedom from target lesion revascularization rates, preventing more than 95% of patients from needing a reintervention after 1 year,” William A. Gray, MD, system chief of the division of cardiovascular diseases and president of Lankenau Heart Institute at Main Line Health in Wynnewood, Pennsylvania, who presented the IMPERIAL findings at TCT 2018, said in the release. “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.”

Disclosure: Gray reports that he is an adviser for Boston Scientific.