Orchestra BioMed has announced plans to commence a study of its non-coated angioplasty system, Virtue Sirolimus AngioInfusion Balloon (SAB), to treat coronary in-stent restenosis (ISR) patients.
The latest development comes after the US Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval with conditions for the study dubbed Virtue ISR-US.
The study will evaluate the safety and efficacy of the angioplasty system.
Virtue SAB is created to facilitate the delivery of an investigational, extended-release sirolimus formulation called SirolimusEFR to the artery during balloon angioplasty.
This approach does not require a permanent implant or balloon coating.
The prospective, randomised, double-blind, multi-centre, controlled trial will analyse Virtue SAB against plain old balloon angioplasty (POBA) to treat single-layer coronary ISR.
Target lesion failure at 12 months is the primary efficacy and safety endpoint of the trial.
The pivotal study will randomise nearly 300 subjects into a 2:1 ratio to receive treatment with Virtue SAB or POBA.
The latest IDE approval from the FDA was based on favourable three-year follow-up data from the SABRE Study in coronary ISR patients.
Subject enrolment will commence on finishing standard trial commencement works such as approvals from the clinical centre institutional review board.
The company is also required to submit further data to the FDA under the IDE approval.
Orchestra BioMed president, chief operating officer and founder Darren Sherman said: “We believe that Virtue SAB has the potential to address a significant unmet clinical need and improve outcomes for a patient population with suboptimal treatment options.
“In a field currently dominated by paclitaxel-coated balloons, Virtue SAB is the only device that provides protected delivery of extended-release sirolimus, the class of drugs used on all currently marketed coronary drug-eluting stents, to the treated artery during angioplasty without the need for a coating or a permanent implant.”
