Orchestra’s drug-eluting balloon wins breakthrough desig

Orchestra BioMed has received an US FDA breakthrough device designation for its Virtue drug-eluting angioplasty balloon system.

The Virtue DEB system delivers sustained-release sirolimus directly to the walls of the blood vessel without the use of a traditional drug coating.

The porous balloon elutes the drug enclosed in a bioabsorbable nanoparticle, which allows it to avoid using a coating that may produce downstream particulates or small blood clots as well as the hazards that come with an additional permanent metal implant.

Known as coronary in-stent restenosis, the procedure represents more than 10% of all cardiology interventions, including repeat procedures, the company said.

It is typically performed with a plain balloon angioplasty or radioactive brachytherapy.

“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,” Darren Sherman, Orchestra’s president, chief operating officer and founder, said in a statement.

The FDA’s designation follows its warnings to healthcare providers about paclitaxel-coated balloons and eluting stents regarding long-term mortality concerns in patients with peripheral artery disease.

Though paclitaxel-coated stents have been approved for coronary artery disease, no coated balloons or stents are currently being marketed in the indication, the FDA said.