Spectranetics' Stellarex DCB Takes Another Step Toward United States Market Approval With PMA Submission

November 2, 2016—The Spectranetics Corporation announced it has submitted the premarket approval (PMA) application to the US Food and Drug Administration for its Stellarex drug-coated angioplasty balloon (DCB). Stellarex is designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease.

The PMA application comes as promising clinical trial results for Stellarex were presented at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. According to Spectranetics, Stellarex has been evaluated extensively across the ILLUMENATE series of randomized controlled trials, which consists of more than 1,100 patients. In the ILLUMENATE First-In-Human study, primary patency rates in the predilatation arm were 89.5% and 80.3% at 12 and 24 months, respectively. In the ILLUMENATE Global study, initial data from more than 200 patients have shown an 86.5% primary patency rate at 12 months.

"Key opinion leaders have called the results reported to date 'remarkable,' especially in light of Stellarex’s low drug concentration," said Amanda Johnson, Spectranetics’ Vice President of Regulatory and Medical Affairs, in the announcement. Stellarex uses EnduraCoat technology, which the company describes as a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site.

Spectranetics anticipates launch of Stellarex in the United States market in the second half of 2017. Stellarex was launched in Europe in January 2015.