The US Food and Drug Administration (FDA) has granted breakthrough device designation to Orchestra BioMed’s Virtue Sirolimus-Eluting Balloon (SEB) for treating patients with coronary in-stent restenosis (ISR).
Coronary ISR involves the reclogging of an artery after the implantation of a drug-eluting or bare metal stent.
Virtue SEB is a non-coated drug-eluting balloon system meant for sustained release of bioabsorbable nanoparticle-encapsulated sirolimus, a drug indicated to prevent restenosis.
The system delivers sirolimus to the artery during balloon angioplasty. It is said to be the first non-coated sirolimus-eluting angioplasty balloon system with a favourable clinical profile in coronary ISR.
In non-clinical studies, the elution profile of Virtue SEB was observed to be similar to that of existing drug-eluting stents.
Orchestra BioMed founder, president and CEO Darren Sherman said: “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.”
Breakthrough Designation is granted to certain medical devices and device-led combination products that provide a more effective treatment of life-threatening or irreversibly debilitating diseases than other options on the market. It enables manufacturers to provide patients and health care providers with timely access to medical devices by expediting their development, assessment, and review.
Under the programme, Orchestra BioMed expects prioritised review of its Virtue SEB application.
Sherman added: “We plan to fully leverage the benefits of FDA Breakthrough Device designation as we seek to accelerate the US clinical and regulatory development of Virtue SEB with the goal of providing physicians and patients with the benefits of our novel therapeutic device.”
Data from the American College of Cardiology’s National Cardiovascular Data Registry (NCDR) reveals that Coronary ISR represents more than 10% of all interventional cardiology procedures.