Spectranetics (NSDQ:SPNC) is touting 2-year data, published in the journal Catheterization & Cardiovascular Interventions, on the Stellarex the drug-eluting balloon it bought from Covidien early this year.
Data from the 78-patient Illumenate 1st-in-human study showed primary patency rates of 89.5% at 1 year and 80.3% at 2 years, Colorado Springs, Colo.-based Spectranetics said. The rate of freedom from clinically driven target lesion revascularization was 90.0% after a year and 85.8% at 24 months, according to the company.
There were no amputations or cardiovascular deaths at 24 months, Spectranetics said. The Stellarex balloon, which Covidien sold to appease anti-trust regulators for its $50 billion merger with Medtronic (NYSE:MDT), uses 50% to 75% lower drug density than rival drug-coated balloons, Spectranetics said.
Stellarex won CE Mark approval in the European Union last December, a month after Covidien announced the deal with Spectranetics.
An investigational device exemption trial is under way in the U.S. and abroad ahead of a bid for approval here, Spectranetics said, and there are 4 additional Illumenate studies examining the device.
"Stellarex DCB is the only drug-coated angioplasty balloon that has demonstrated 80.3% patency at 24 months. We are very pleased with these promising results. Getting this data published in a peer-reviewed journal is a critical step to informing physicians and facilitating evidence-based decisions," lead investigator Dr. Henrik Schroeder, of Berlin’s Jewish Hospital, said in prepared remarks.
"Publication of the Illumenate FIH Study in CCI solidifies the rigor and results coming out of the trial. We believe that the inclusion of the data speaks volumes to the impact its findings will have on patient care," added Spectranetics regulatory & medical affairs vice president Amanda Johnson. "The market will have a choice in [drug-eluting balloon] technology and we are confident Stellarex clinical findings will drive that decision in the name of positive outcomes."