By Tamara Mathias

(Reuters) – The U.S. Food and Drug Administration on Monday approved Boston Scientific Corp’s drug-coated stent Eluvia to treat narrowed arteries in the leg.

The medical device maker intends to launch Eluvia in the fourth quarter, Jeff Mirviss, president of Boston Scientific’s Peripheral Interventions division, told Reuters.

Eluvia, approved in Europe since 2016, targets the 8.5 million people in the United States who suffer from peripheral artery disease (PAD), a painful condition caused by plaque buildup in the arteries of the limbs. If left untreated, the condition could result in an amputation.

The company estimates the global market size to be upwards of $1 billion, Mirviss said.

Eluvia is a tiny wire mesh scaffolding with a drug-polymer coating that releases paclitaxel, an existing chemotherapy drug, for about a year to prevent reclogging.

Data from a trial in 475 patients showed Eluvia was more effective over a year than privately held Cook Medical’s Zilver PTX stent, the only rival drug-eluting stent currently available, according to Boston Scientific.

Only 1 in 20 patients on Eluvia required a repeat procedure, compared with roughly 1 in 10 that used Zilver.

“Eluvia releases the drug over a year…the Cook Zilver PTX stent releases drug for only about 60 days. And so that, we believe, is why we’re seeing the superior results,” Mirviss said.

Unlike heart stents, which have been in use for over a decade, stents made for arteries in the leg have to contend with larger blood vessels and the need to be flexible to accommodate for movement.

Eluvia is also expected to rival other technologies including drug-coated balloons and bare-metal stents, Boston Scientific said.

(Reporting by Tamara Mathias in Bengaluru; Editing by Sriraj Kalluvila)