April 23, 2019
Orchestra BioMed's Virtue Sirolimus-Eluting Balloon Receives FDA Breakthrough Device Designation
April 24, 2019—Orchestra BioMed, Inc. announced that it has secured FDA Breakthrough Device designation for its noncoated Virtue sirolimus-eluting balloon (SEB) for the treatment of coronary in-stent restenosis (ISR).
Through the Breakthrough Device program, Orchestra BioMed expects to receive prioritized FDA review of its submission for the Virtue SEB and will accelerate the United States clinical and regulatory development of the device, noted the company.
Dean Kereiakes, MD, commented in Orchestra BioMed's announcement, “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. Kereiakes continued, "The unique design of Virtue SEB provides a reliable way to apply the proven antiproliferative, antirestenotic 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 microemboli. Clinical results at 3-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 United States.”
The company noted that Juan Granada, MD, presented 3-year clinical results with the Virtue SEB from the SABRE trial at TCT 2018, the Transcatheter Cardiovascular Therapeutics conference held September 21–25 in San Diego, California. In SABRE, the Virtue SEB demonstrated excellent efficacy and safety performance in a very challenging ISR patient population with predominantly long, diffuse lesions within stents that had been implanted, on average, approximately 4 years before the study enrollment. The per-protocol primary safety and efficacy endpoint results of the study included 0.0% major adverse cardiac events both in-hospital and at 30-day follow-up, 0.12-mm late lumen loss at 6-month angiographic assessment, and 5.6% target lesion failure at 3 years, advised Orchestra BioMed.