The FDA has approved a 5mm diameter version of Cook Medical’s drug-eluting stent for use in the treatment of peripheral artery disease (PAD).
The 5mm version of Zilver PTX is better suited for narrower arteries and will be a useful tool in the treatment of lesions in superficial femoral arteries (SFAs), according to Cook.
Zilver PTX was the first drug-eluting stent cleared for use in PAD in the U.S. but now faces competition from Boston Scientific’s recently-approved Eluvia, which received the federal green light Monday.
55-year-old Cook has historically been an early mover into new stent markets. Its Zilver Vena Venous Stent broke new ground in 2011 when it received a CE mark in the treatment of diseased veins, and Zilver PTX cornered the U.S. PAD drug-eluting stent market when it first received clearance in 2012.
However, Cook faces growing competition from rival Boston Scientific in these niches.
Marlborough, Massachusetts-based Boston Scientific bought its way into the market for stents to treat venous diseases last month when it paid $108 million upfront to acquire Veniti, one of Cook’s rivals in the field, and positioned itself to challenge for PAD patients this week by winning FDA approval for Eluvia.
Eluvia is coming to market backed by head-to-head clinical trial results that suggest it may have an edge over Zilver PTX. However, Cook has used its first-mover advantage to gather long-term outcomes data and expand its portfolio of Zilver PTX devices. The new diameters and lengths of Zilver PTX are intended to meet the demands of physicians and suit varying vessel sizes.
“We spend a lot of time listening to physicians to understand their clinical needs. Time and time again, they ask for more treatment options for peripheral artery disease,” Mark Breedlove, VP of Cook’s vascular division, said in a statement.
The latest addition to the range is a 5mm diameter stent — the narrowest in the Zilver PTX range. The product is available in lengths of up to 140mm and indicated for use in 4mm diameter vessels. The approval of the 5mm stent comes a month after Cook introduced 6mm and 7mm versions of Zilver PTX in lengths of up to 140mm. The devices enable the treatment of lesions up to 300mm long.