Boston Scientific
(NYSE: BSX)
announced today that it received FDA approval for its Agent drug-coated balloon (DCB).
The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel.
Marlborough, Massachusetts-based Boston Scientific plans a U.S. launch for Agent in the coming months. It already has availability in Europe, parts of Asia Pacific and Latin America. The system treats patients with ISR and previously untreated small vessel coronary disease.
Agent serves as an alternative to traditional therapies like balloon angioplasty, additional layers of stenting or radiation. The paclitaxel-coated balloon transfers a therapeutic dose of drug to the vessel wall, helping to prevent ISR reoccurrence.
The FDA approved the device, which received breakthrough designation in 2021, thanks to results from an investigational device exemption (IDE) trial. Data presented at TCT 2023 demonstrated statistical superiority for Agent compared to uncoated balloon angioplasty. Boston Scientific set a primary endpoint of target lesion failure at 12 months. Agent DCB topped balloon angioplasty with 17.9% target lesion failure compared to 28.7%.
“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,” said Lance Bates, president, Interventional Cardiology Therapies, Boston Scientific. “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.”
The analysts’ view on the latest win for Boston Scientific
BTIG analysts Marie Thibault and Sam Eiber maintain their “Buy” rating for Boston Scientific following Agent’s approval.
“We view Agent highly favorably for its statistically significant superiority in what is a difficult-to-treat and common ISR patient population, which we think could enable rapid physician adoption,” the analysts wrote.
They also noted that, in addition to European and Japanese availability, they expect a launch for Agent in China next year. According to Thibault and Eiber, Boston Scientific also hopes to explore segments beyond ISR. That includes potential use in small vessels, bifurcations and acute coronary syndrome.
“These remain compelling long-term market expansion opportunities which together represent a potential $1B global market, according to [Boston Scientific],” the analysts said.