The 371-patient Illumenate global study included lesions which were “highly complex,” according to the Colorado Springs, Colo.-based company, and a high proportion of chronic total occlusions and severe calcifications, at 31% and 41%, respectively.
At 1-year, data indicated a primary patency rate of 81.4%, with freedom from clinically-driven target lesion revascularization at 94.8%
“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,” Dr. Thomas Zeller of the Leipzig Interventional Course said in a prepared statement.
“At Spectranetics we aim to lead the way in clinical science, and are proud to have the only DCB with proven results in complex patients. As KOLs have stated, Stellarex is a next-generation DCB providing top-tier efficacy with a low drug dose,” CEO & prez Scott Drake said in a press release.
Last November, Spectranetics said it won CE Mark approval in the European Union for a smaller size of its Stellarex drug-coated balloon.
The Stellarex 0.014″ device is designed to treat small vessels, below-the-knee disease and challenging critical limb ischemia. The larger, 0.035″ device won CE Mark approval in December 2014, just before Spectranetics paid Covidien $30 million deal for the angioplasty platform following the consummation of Medtronic‘s (NYSE:MDT) $50 billion merger with Covidien.
The company filed for pre-market approval from the FDA for Stellarex earlier in November, based on 1-year data from its pivotal Illumenate study.
The post Spectranetics touts high primary patency, low CD-TLR for Stellarex DCB data in complex cases appeared first on MassDevice.
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