Spectranetics Corp. reported strong results from a 371-patient global study of patients on its Stellarex drug-coated balloon to treat peripheral arterial disease, helping position the company to compete with Medtronic PLC and C. R. Bard Inc.
The vessel achieved a primary patency rate of 81.4%. That means that the device successfully opened more than fourth-fifths of the blocked or narrowed peripheral arteries, which are the defining feature of peripheral artery disease. In addition, freedom from clinically-driven target lesion revascularization was 94.8%.
Studies of the device, including its ongoing U.S. clinical trial for FDA approval, have enrolled a more challenging patient population than those previous studies of the FDA approved drug-coated balloons made by Medtronic and Bard, according to Guggenheim equity analyst Chris Pasquale.
"Up until now, the marketing debate in the field has largely been one of efficacy vs. safety, with Medtronic touting its superior clinical data and Bard attempting to sew concerns about potential issues with [Medtronic's] high drug dose and downstream particulate generation," Pasquale wrote.
The analyst believes Spectranetics will be able to use this backdrop to position the product as "a best-of-both-worlds solution," combining strong efficacy with a low dose drug formulation that will enable it to take meaningful share after launching in the U.S. Pasquale projects U.S. Stellarex sales of $38 million in 2018, rising to $104 million in 2020.
The device launched in Europe in January 2015. Spectranetics filed for FDA approval in November and expects to obtain it in the second half of 2017.