Boston Scientific claims first US approval for drug-coated coronary balloon

Boston Scientific has received FDA approval for its Agent drug-coated balloon sized to fit within blocked or constricted coronary arteries, nearly a decade after it made its European debut.

The company said the green light makes the paclitaxel-equipped device the first of its kind in the U.S. for the treatment of coronary in-stent restenosis, where the path cleared by a previously placed heart stent has been overtaken by plaque or scar tissue.

Boston Scientific estimates that in-stent restenosis drives about 10% of all percutaneous coronary procedures in the U.S. and says the addition of a dose of paclitaxel to the blood vessels’ walls can help prevent its reoccurrence. 

The company previously obtained a CE mark in Europe for the Agent balloon in mid-2014 for in-stent stenosis as well as for untreated cases of coronary artery disease. The system is also available in parts of Latin America and the Asia-Pacific region, with an approval in Japan last year.

“With more than 100,000 patients treated globally to date in both clinical and commercial settings, we are very pleased to introduce this proven therapy as the first drug-coated coronary balloon in the U.S,” Boston Scientific’s interventional cardiology president, Lance Bates, said in a statement.

The company said it plans to begin rolling out the device—which received a breakthrough designation from the FDA in 2021—in the U.S. in the coming months.

“The AGENT DCB addresses a critical unmet need by providing a dedicated treatment option for the challenging condition of ISR and we look forward to offering U.S. physicians the opportunity to treat their patients with this novel device,” said Bates.

At the Transcatheter Cardiovascular Therapeutics conference last October, Boston Scientific presented a late-breaking study showing the Agent balloon could reduce the risk of blocked blood flow by 38% compared to uncoated balloons. Lesion failure rates after one year totaled 17.9% for the Agent procedure, compared to 28.7% in the trial’s control arm. 

The drug-coated balloon also reported zero cases of blood clotting within the stent, compared to a rate of 3.9% with typical angioplasty.