January 23, 2017
ILLUMENATE Global 12-Month Data Presented for Spectranetics' Stellarex DCB
January 24, 2017—The Spectranetics Corporation announced that the final 12-month results from the ILLUMENATE Global Study of the Stellarex drug-coated balloon (DCB) were presented by Professor Thomas Zeller, MD, at LINC 2017, the Leipzig Interventional Course in Leipzig, Germany. The ILLUMENATE Global Study is a prospective, multicenter, single-arm study designed to assess the clinical performance of the Stellarex DCB in the superficial femoral and popliteal arteries.
Prof. Zeller commented in the company's announcement, “In a real-world setting, ILLUMENATE Global validates the earlier ILLUMENATE US Pivotal results, achieving best-in-class 12-month primary patency rates in a patient cohort with the highest rate of severe calcium yet studied. These results are significant because severe calcium has been one of the greatest challenges in our DCB practice.”
The ILLUMENATE Global trial enrolled 371 patients. The treated lesions were highly complex, including a high proportion of chronic total occlusions (31%) and severe calcification (41%), as reported by an independent angiographic core laboratory. Per Kaplan-Meier survival estimates at day 365, key results include primary patency of 81.4% and freedom from clinically driven target lesion revascularization of 94.8%.
The Stellarex DCB platform is designed to treat peripheral artery disease. According to Spectranetics, the EnduraCoat technology used on the Stellarex DCB is a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site.
Spectranetics launched the device in Europe in January 2015. It is not available for sale in the United States, where commercialization is anticipated in the second half of 2017.