Spectranetics Completes Enrollment in ILLUMENATE Pivotal Study to Assess Safety and Efficacy of Stellarex(TM) Drug-Coated Balloon Technology

300 Patients Enrolled at 42 Sites; Completion of Enrollment a Milestone in Timeline for U.S. Food and Drug Administration Approval of Stellarex(TM) 

COLORADO SPRINGS, Colo., The Spectranetics Corporation today announced it has completed enrollment of 300 subjects in the ILLUMENATE Pivotal clinical study, a prospective, randomized controlled, multicenter study designed to assess the clinical performance of the Stellarex™ drug-coated angioplasty balloon used to restore and maintain blood flow to above-the-knee arteries of the leg in patients with peripheral arterial disease (PAD).

The ILLUMENATE Pivotal study includes patients with superficial femoral or popliteal artery lesions, three to 14 cm in length, and will assess the safety and efficacy of Stellarex at 12 months, with follow-up to five years. Enrollment is now complete for all five studies in the ILLUMENATE series of clinical studies.

"When it comes to patient care, physicians demand clinical results that demonstrate evidence-based outcomes," stated Prakash Krishnan, MD, Mount Sinai Medical Center, New York, N.Y., co-primary investigator and leading enrollment site. "As lesion complexity increases among patients being treated with minimally invasive techniques for peripheral arterial disease, I'm pleased to be part of this trial and the study of a new technology that will give physicians proven treatment outcomes and durable options for vascular care."

Completion of clinical study enrollment is a major step toward premarket approval (PMA) with the U.S. Food and Drug Administration, which will be filed after one-year follow-up visits with all patients are completed.

"Based on early clinical evidence from our First-In-Human study demonstrating the favorable impact of Stellarex, we are pleased ILLUMENATE Pivotal has achieved this critical milestone toward our FDA submission. Drug-coated balloons are a significant part of the vascular landscape and Dr. Krishnan and ILLUMENATE Pivotal trial investigators are producing the clinical data that physicians require and patients deserve," states Amanda Johnson, Vice President, Regulatory and Medical Affairs, Spectranetics.

About the Stellarex™ DCB Platform
The Stellarex drug-coated balloon platform is designed to treat peripheral arterial disease. Stellarex uses EnduraCoat™ technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. The Stellarex DCB platform received European CE mark approval in December 2014 and launched in Europe in January 2015. It is not approved in the United States.

About ILLUMENATE Pivotal Study
The ILLUMENATE Pivotal study is a prospective, randomized controlled, multicenter study designed to assess the clinical performance of the Stellarex DCB in the United States. ILLUMENATE Pivotal is studying the treatment of above-the-knee peripheral arterial disease in 300 patients at 42 sites in the United States and Austria.

About ILLUMENATE Clinical Trials
There are four ILLUMENATE clinical studies in addition to the ILLUMENATE Pivotal trial, described above:

• ILLUMENATE First-In-Human (FIH) – a non-randomized, multicenter study; 80 patients; primary patency rate at 12 months was 89.5% and 80.3% at 24 months; freedom from clinically driven target lesion revascularization rate at 12 months was 90.0% and 85.8% at 24 months
• ILLUMENATE Pharmacokinetic Study – designed to evaluate the drug levels in the blood; 25 patients enrolled at up to two sites
• ILLUMENATE European Randomized Trial – similar to the U.S. Pivotal trial; 328 patients enrolled at 19 sites
• ILLUMENATE Global Registry – non-randomized; 371 patients enrolled at 37 sites

These five clinical studies are being used to evaluate the safety and effectiveness of the Stellarex DCB platform and support United States and Canada regulatory filings.

Source:  Spectranetics