Virtue® Sirolimus-Eluting Balloon (SEB) to treat Coronary In-Stent Restenosis (ISR)

Orchestra Biomed designed Virtue to deliver Nanoparticle-encapsulated sirolimus to the arteries of patients with coronary in-stent restenosis (ISR) during balloon angioplasty.

Virtue® Sirolimus-Eluting Balloon (SEB) is a novel, first-in-class drug/device combination product that delivers sustained-release bioabsorbable nanoparticle-encapsulated Sirolimus, the proven gold-standard drug for preventing restenosis, directly to the artery during balloon angioplasty without the need for a coating.

This is a new treatment option without any side effects, providing ISR patients with the benefits of sirolimus without exposing them to the risks associated with permanent metal implants and balloon coating.

Virtue SEB is the first and only non-coated sirolimus-eluting angioplasty balloon system that provides arterial delivery of sirolimus.

The design of Virtue SEB provides a reliable way to apply the proven anti-proliferative, anti-restenosis 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.

Virtue SEB is potential to offer significant advantages for treatment of coronary in-stent restenosis (ISR), a condition that represents over 10% of total interventional procedures.

Along with coronary ISR, Virtue® SEB has significant follow-on clinical indications such as treatment of small (<2.75mm) vessels, bifurcated lesions, below-the-knee lesions and others.

Virtue SEB received FDA's breakthrough device designation. Virtue SEB also show promising clinical results in patients with coronary ISR.

Coronary ISR, the reclogging of an artery following the implant of a drug-eluting or bare metal stent, represents over 10% of total interventional cardiology procedures according to the American College of Cardiology’s National Cardiovascular Data Registry (NCDR). In the SABRE trial, 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, nearly four years prior to the study enrollment.