Pennsylvania-based health company Orchestra BioMed has obtained FDA breakthrough device designation for its Virtue sirolimus-eluting balloon (SEB), according to a statement issued April 24.
Virtue SEB, a drug/device combination product that delivers sustained-released bioabsorbable nanoparticle-encapsulated sirolimus directly to a patient’s artery during balloon angioplasty, works without the need for a drug coating, Orchestra said. It’s intended for use in individuals with coronary in-stent restenosis (ISR), a complication that comprises more than 10% of total interventional cardiology procedures.
Virtue delivers sirolimus, a common drug used to prevent ISR, to the artery with an elution profile that’s comparable to commercially available drug-eluting stents, according to Orchestra. To date, it’s the first and only non-coated sirolimus-eluting angioplasty balloon system to show promising clinical results in patients with coronary ISR, reaching 5.6% target lesion failure at three years in the SABRE trial.
The same study also found a 0% rate of major adverse cardiac events in-hospital and at one month post-implant and identified 0.12 mm late lumen loss at six-month angiographic assessment.
“In Virtue SEB, we finally have a therapeutic innovation that truly warrants breakthrough designation for the treatment of coronary ISR, a particularly challenging condition for which available treatment options are limited,” Dena Kereiakes, MD, medical director of the Christ Hospital Heart and Vascular Center and a professor of clinical medicine at Ohio State University, said in the release. “The unique design of Virtue SEB provides a reliable way to apply the proven anti-proliferative, anti-restenotic benefits of sirolimus during balloon angioplasty without the potential hazards of a permanent metal implant or a balloon coating that may produce downstream particulates and micro-emboli.”
The FDA grants devices breakthrough designation if there’s sufficient evidence that the technology could provide a more effective treatment for life-threatening or irreversibly debilitating diseases. The agency prioritizes the review of such devices, expediting their time to market.