The Stellarex drug-coated balloon made by Spectranetics (NSDQ:SPNC) beat out percutaneous transluminal angioplasty in the 300-patient Illumenate pivotal study reported today at the 2016 Transcatheter Cardiovascular Therapeutics Symposium.
The study followed a complex group of patients over 12 months to evaluate the low-dose balloon’s efficacy and safety. Nearly 50% of the patient population had diabetes, 43.9% had high rates of severe calcification, 45% suffered from cardiovascular disease, and 18% had renal insufficiency. The primary safety endpoint was a composite of freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and clinically driven target lesion revascularization; the primary efficacy endpoint was a composite of primary patency, freedom from restenosis and clinically-driven TLR.