Stellarex Drug-Coated Balloon for PAD Approved by FDA

Spectranetics, based in Colorado Springs, Colorado, won FDA approval to bring to the U.S. market its Stellarex drug-coated balloon catheter. The device is designed and indicated for helping to restore and keep open the lumen of superficial femoral and popliteal arteries in patients with peripheral artery disease.

The device features the company’s EnduraCoat Technology that gradually releases paclitaxel, an antiproliferative for the prevention of buildup at the treatment site, while keeping it from shedding from the balloon during delivery of the device. Moreover, it seems to work well while actually releasing a smaller dose of paclitaxel than comparable devices.

“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. 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,” in a statement said Dr. Prakash Krishnan, ILLUMENATE Pivotal Trial’s Co-Principal Investigator, Mount Sinai in New York.

From Spectranetics:

Throughout the ILLUMENATE Trial Series, Stellarex DCB’s EnduraCoat™ Technology demonstrates both safety and efficacy with consistently high patency rates and low clinically driven target lesion revascularization rates in a range of lesion complexities and patient co-morbidities. The device offers both hybrid paclitaxel crystallinity and a durable excipient to provide efficient drug transfer, effective drug residency with high coating durability and minimal particulate loss.

Here’s Spectranetics showing off how well its Stellarex holds on to the drug coating:

Product page: Stellarex…

Via: Spectranetics…