Spectranetics Announces FDA Approval of Stellarex™ Drug-Coated Balloon



Stellarex produces top-tier clinical outcomes with a low drug dosage


COLORADO SPRINGS, Colo., July 26, 2017 (GLOBE NEWSWIRE) — The Spectranetics Corporation (NASDAQ:SPNC) today announced receipt of U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) of the Stellarex™ drug-coated balloon (DCB), designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease (PAD).

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

Dr. Sean Lyden, ILLUMENATE Pivotal Trial’s Co-Principal Investigator, Cleveland Clinic, Cleveland, Ohio added, “The ILLUMENATE Pivotal Trial treated a challenging patient population with a low paclitaxel drug dose.  When considering options, I think most clinicians would prefer to use a lower drug dose if they can also achieve great patency results.”

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.

“The Stellarex DCB delivers top-tier clinical results for common to complex…

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