FDA News

Sirolimus-eluting balloon receives FDA breakthrough device designation

Dean J. Kereiakes
Dean J. Kereiakes

Orchestra BioMed announced that a sirolimus-eluting balloon has received a breakthrough device designation from the FDA for the treatment of patients with coronary in-stent restenosis.

The sirolimus-eluting balloon (Virtue SEB) is a novel device that delivers sirolimus with bioabsorbable particles with an elution profile, according to a press release from the company.

“In Virtue SEB, we finally have a therapeutic innovation that truly warrants breakthrough designation for the treatment of coronary [in-stent restenosis], a particularly challenging condition for which available treatment options are limited,” Cardiology Today’s Intervention Editorial Board Member Dean J. Kereiakes, MD, FACC, FSCAI, medical director of The Christ Hospital Heart and Vascular Center in Cincinnati and professor of clinical medicine at The Ohio State University in Columbus, said in the release. “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.”

The balloon’s safety and efficacy has been shown in results of the SABRE trial, which were presented at TCT in 2018, according to the press release.

“We believe Virtue SEB addresses an important unmet clinical need and provides an improved treatment alternative for a patient population with limited options,” Darren R. Sherman, president, chief operating officer and founder of Orchestra BioMed, said in the press release.

Disclosures: Kereiakes reports he has a financial interest/arrangement or affiliation with Abbott Vascular, Ablative Solutions, Boston Scientific, Caliber Therapeutics, Micell Technologies, Shockwave, SINO Medical Sciences Technologies and Svelte Medical Systems. Sherman is the founder of Orchestra BioMed.

Dean J. Kereiakes
Dean J. Kereiakes

Orchestra BioMed announced that a sirolimus-eluting balloon has received a breakthrough device designation from the FDA for the treatment of patients with coronary in-stent restenosis.

The sirolimus-eluting balloon (Virtue SEB) is a novel device that delivers sirolimus with bioabsorbable particles with an elution profile, according to a press release from the company.

“In Virtue SEB, we finally have a therapeutic innovation that truly warrants breakthrough designation for the treatment of coronary [in-stent restenosis], a particularly challenging condition for which available treatment options are limited,” Cardiology Today’s Intervention Editorial Board Member Dean J. Kereiakes, MD, FACC, FSCAI, medical director of The Christ Hospital Heart and Vascular Center in Cincinnati and professor of clinical medicine at The Ohio State University in Columbus, said in the release. “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.”

The balloon’s safety and efficacy has been shown in results of the SABRE trial, which were presented at TCT in 2018, according to the press release.

“We believe Virtue SEB addresses an important unmet clinical need and provides an improved treatment alternative for a patient population with limited options,” Darren R. Sherman, president, chief operating officer and founder of Orchestra BioMed, said in the press release.

Disclosures: Kereiakes reports he has a financial interest/arrangement or affiliation with Abbott Vascular, Ablative Solutions, Boston Scientific, Caliber Therapeutics, Micell Technologies, Shockwave, SINO Medical Sciences Technologies and Svelte Medical Systems. Sherman is the founder of Orchestra BioMed.