FDA deems Orchestra BioMed's sirolimus-eluting balloon a breakthrough device for coronary restenosis

The breakthrough designation follows the FDA's warnings over paclitaxel-coated balloons and eluting stents regarding long-term mortality concerns in patients with peripheral artery disease. (Orchestra BioMed)

Orchestra BioMed has received an FDA breakthrough device designation for its drug-eluting angioplasty balloon, designed to open up the coronary arteries of the heart after they’ve reclogged following the placement of a stent.

While physically widening the artery, the company’s Virtue system delivers sustained-release sirolimus directly to the walls of the blood vessel without the use of a traditional drug coating.

The porous balloon instead elutes the drug enclosed in a bioabsorbable nanoparticle, which Orchestra said 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.


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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.

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

“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,” Sherman added.

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.

A preliminary analysis reported by the agency last month identified “a potentially concerning signal” in patients treated with paclitaxel-coated products compared to those treated with uncoated devices after two to five years. The agency also recently scheduled an advisory panel meeting for June to receive recommendations on appropriate regulatory actions.

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.

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