Biomedical innovation company Orchestra BioMed announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for its Virtue Sirolimus-Eluting Balloon (SEB) to treat coronary in-stent restenosis (ISR).
Orchestra BioMed said that Breakthrough Device designation is usually granted to certain medical devices and device-led combination products that contribute for an effective treatment of life-threatening or irreversibly debilitating diseases.
The designation is expected to enable the manufacturers to provide patients and health care providers with timely access to medical devices by expediting their development, assessment, and review.
Orchestra BioMed expects the designation benefits through frequent interactions and feedback from FDA during the premarket review phase and anticipates prioritized review of its submission for Virtue SEB.
Virtue SEB has been designed to deliver sustained-release of bioabsorbable nanoparticle-encapsulated Sirolimus and gold-standard drug for preventing restenosis, directly to the artery during balloon angioplasty without the need for a coating.
Virtue SEB is capable of delivering sirolimus through bioabsorbable particles directly to the artery with an elution profile comparable to commercially available drug-eluting stents and the extensive non-clinical studies demonstrating the device applications have been published in a peer-reviewed journal.
Orchestra BioMed claimed that the Virtue SEB marks the first and only non-coated sirolimus-eluting angioplasty balloon system to show promising clinical results in patients with coronary ISR.
Orchestra BioMed president, chief operating officer and founder 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.”
FDA approved treatment options, like plain balloon angioplasty and brachytherapy are limited and provides substandard clinical outcomes.
The Sirolimus Angioplasty Balloon for In-Stent Restenosis (SABRE) Trial, conducted by Columbia University College of Physicians and Surgeons associate professor of Medicine Dr. Juan Granada, has presented three-year clinical results with Virtue SEB.
The SABRE trial showed that Virtue SEB effective and safe performance in a very challenging ISR patient population with primarily long, diffuse lesions within implanted stents, approximately four years prior to the study enrollment.
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.”