ILLUMENATE 12-Month Interim Data Support Spectranetics' Stellarex DCB

April 26, 2016—The Spectranetics Corporation announced that 12-month interim data from the ILLUMENATE Global Study were presented by Global Principal Investigator Prof. Thomas Zeller, MD, at the Charing Cross Symposium in London, United Kingdom. 

The prospective, multicenter, single-arm study is designed to assess the clinical performance of the company’s Stellarex drug-coated balloon (DCB) in the superficial femoral and popliteal arteries. The ILLUMENATE Global Study includes angiographic and duplex ultrasound core lab assessments, as well as an independent clinical events committee (CEC) to adjudicate adverse events.

According to the company, the interim results from the first 153 of 371 patients enrolled demonstrated a primary patency rate of 84.7% at 12 months. Other key interim results that are fully core lab and CEC adjudicated from the first 153 patients (174 lesions) at 365 days include a freedom from clinically driven target lesion revascularization rate (CD-TLR) of 91%, and 84% of patients experienced an improvement in their walking distance score.

Prof. Zeller, who is from the University Heart Center Freiburg-Bad Krozingen, Germany, commented in the company’s announcement, “The 12-month interim results of the ILLUMENATE Global Study demonstrate consistency with the promising results observed in the previously published ILLUMENATE First-In-Human Study. Overall, these interim results compare well with the highest DCB patency rates reported in comparable studies with similar patient populations, but with a lower level of drug concentration.”

The Stellarex DCB is designed to restore and maintain blood flow to the superficial femoral and popliteal arteries of the leg in patients with peripheral arterial disease. The Stellarex DCB 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 device received European CE Mark approval in December 2014 and was launched in Europe in January 2015. The Stellarex DCB is not available for sale in the United States, where commercialization is anticipated to take place in 2017.