Eluvia Gains FDA Approval Just Days After IMPERIAL Results Released

SAN DIEGO, CA—Endovascular operators in the United States didn’t have to wait long after the positive results of the IMPERIAL trial to get a new tool to treat their patients with femoropopliteal disease.

The US Food and Drug Administration (FDA) has approved the Eluvia paclitaxel-eluting stent, manufacturer Boston Scientific announced Monday, just 2 days after William Gray, MD (Lankenau Heart Institute, Wynnewood, PA), reported here at TCT 2018 that the device resulted in superior primary patency relative to the Zilver PTX paclitaxel-eluting stent (Cook Medical).

Before the FDA’s decision, Gray told TCTMD he would be “shocked” if the results did not lead to US approval, a stance supported by other interventionalists.

In addition to showing a superior result in terms of primary patency, IMPERIAL established that Eluvia was noninferior to Zilver PTX in terms of major adverse events, with numerically—but nonsignificantly—lower rates of TLR and stent thrombosis in the Eluvia arm.

One interventionalist, Mehdi Shishehbor, DO, PhD (University Hospitals Cleveland Medical Center, OH), predicted that Eluvia would largely displace Zilver PTX.

“The fact that we have a well-powered trial that compares two devices in the same class and shows one is superior to the other to me, I think, is enough justification for us to use the better device,” he told TCTMD. “At least at this moment, I don’t know how to make a justification to use the inferior device given these data.”

Gary Ansel, MD (OhioHealth/Riverside Methodist Hospital, Columbus, OH), however, said Zilver PTX would maintain a role, citing good 5-year data with the device that is not available for Eluvia.

Photo Credit: Eluvia™ Drug-Eluting Vascular Stent System, courtesy of Boston Scientific Corporation