FDA OKs Boston Sci’s Eluvia drug-eluting stent for PAD

On the back of a positive head-to-head trial against a similar stent from Cook Medical, the FDA approved Boston Scientific’s drug-eluting stent, Eluvia, for the treatment of peripheral artery disease (PAD). The study was presented Saturday at the Transcatheter Cardiovascular Therapeutics meeting and will appear in The Lancet. 

PAD affects up to 9 million people in the U.S. and is characterized by narrowed blood vessels that limit blood flow to the limbs and commonly causes pain in the legs. Treatment—such as exercise, diet and medication—focuses on reducing symptoms and stopping progression, while some patients may be treated with stents that prop open blocked arteries. 

Made of wire mesh, the Eluvia stent has a drug-polymer coating that releases paclitaxel for one year. It is designed to stop tissue regrowth that could block the artery. It earned a CE mark in February 2016. 

The Imperial trial was the first head-to-head trial comparing two different drug-eluting stents. It enrolled 465 patients who had lesions in their superficial femoral artery and proximal popliteal artery, which are both located in the leg. The patients were randomized so two-thirds received the Eluvia stent and one-third were treated with Cook Medical’s Zilver PTX stent. 

Both stents improved blood flow at about the same rate, while Eluvia outperformed Zilver PTX in primary patency, that is, keeping the artery open (88.5% vs. 79.5%). Fewer Eluvia patients needed a repeat procedure than Zilver patients, with a target lesion revascularization rate of 4.5% and 9% respectively. 

"These impressive clinical outcomes suggest that sustained elution of paclitaxel, delivered by the Eluvia stent, better matched the timing of restenosis in the [superficial femoral artery] that can occur months later, thereby reducing the need for repeat interventions," said the co-principal investigator, William Gray, M.D., system chief at the Division of Cardiovascular Disease at Main Line Health and president of Lankenau Heart Institute in Wynnewood, Pennsylvania, in the statement. "Based on these findings, we believe that the Eluvia stent can be a preferred therapy option when treating patients with arterial blockages in the superficial femoral or proximal popliteal arteries."