Spectranetics (NSDQ:SPNC) said today that its Stellarex drug-coated balloon won FDA pre-market approval.
The device is designed to treat patients with peripheral arterial disease, bringing blood flow back to the superficial femoral and popliteal arteries.
“The Stellarex DCB has shown safety and efficacy in a cohort of patients which included a higher preponderance of diabetics and core-lab defined severely calcified lesions in the US IDE trial,” the Illumenate pivotal trial’s co-principal investigator, Dr. Prakash Kishnan, said in prepared remarks. “These results, in combination with the cohort of patients studied in the European Randomized Controlled Trial, demonstrate the Stellarex DCB is safe and effective in diverse patient populations when addressing symptomatic femoropopliteal disease.”
“The Illumenate pivotal trial treated a challenging patient population with a low paclitaxel drug dose,” co-principal investigator Dr. Sean Lyden added. “When considering options, I think most clinicians would prefer to use a lower drug dose if they can also achieve great patency results.”
Based on data from the Illumenate clinical program, which included five randomized trials, Spectranetics’ drug-coated balloon proved safe and effective with high patency rates and low clinically-driven target lesion revascularization rates.
“The Stellarex DCB delivers top-tier clinical results for common to complex patients. As the only commercially available DCB with two reported randomized controlled trials, Stellarex has demonstrated durability with consistently high patency rates in a wide range of patients,” president & CEO Scott Drake said. “Our customers refer to Stellarex as a no-compromise solution. This next generation DCB provides proven treatment backed by robust clinical evidence.”
“Spectranetics is a provider of proven solutions to manage the challenges of crossing lesions, preparing vessels, and treating even the most complex coronary and peripheral lesion morphologies,” Scott Hutton, senior VP & GM, added. “We are always focused on better patient care, and with today’s FDA approval, the Stellarex DCB becomes a formidable competitor in the drug-coated balloon market, and a proven solution for those suffering with PAD.”
