Orchestra BioMed (OBIO) received approval from the US Food and Drug Administration to initiate an updated clinical trial for its Virtue Sirolimus AngioInfusion Balloon, a drug-delivery device for heart patients.
The trial will compare Virtue SAB to Boston Scientific's (BSX) AGENT, a paclitaxel-coated balloon, in the treatment of coronary in-stent restenosis, a condition where arteries narrow again after stent placement, the company said.
Virtue SAB uses a non-coated, microporous balloon technology to deliver liquid sirolimus, ensuring protected delivery and extended release of the drug during the critical 30-day healing period.
The new 12-month trial, expected to start in H2, will enroll 740 patients at up to 75 locations across the US.
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