Orchestra BioMed recently announced that its Virtue Sirolimus-Eluting Balloon has received Breakthrough Device destination from the FDA.
The Breakthrough Designation is granted to medical devices and device-led combination products that can provide a more effective treatment of life-threatening or other debilitating diseases. It allows for medical devices to be expedited in their development, assessment and review processes.
“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,” Dr. Dean Kereiakes, medical director of The Christ Hospital Heart and Vascular Center and professor of Clinical Medicine at The Ohio State University, said in a press 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. Clinical results at three-year follow-up with Virtue SEB in ISR are very promising and I am very much looking forward to utilizing this exciting new technology in clinical trials in the U.S.”
Virtue SEB is a drug/device combination product that is designed to deliver sustained-release bioabsorbable nanoparticle-encapsulated Sirolimus, a drug that is used to prevent restenosis. directly to the artery during balloon angioplasty.
“We believe Virtue SEB addresses an important unmet clinical need and provides an improved treatment alternative for a patient population with limited options. It is the first and only non-coated angioplasty balloon that provides arterial delivery of sirolimus, the proven gold standard drug used on drug-eluting stents for preventing restenosis of treated arteries,” Darren Sherman, president, chief operating officer and founder of Orchestra BioMed, said. “We plan to fully leverage the benefits of FDA Breakthrough Device designation as we seek to accelerate the U.S. clinical and regulatory development of Virtue SEB with the goal of providing physicians and patients with the benefits of our novel therapeutic device.”