The regulatory nod makes the device the first coronary drug-coated balloon indicated for in-stent restenosis for patients with coronary artery disease in the US.

Katie Hobbins, Managing Editor

March 1, 2024

2 Min Read
Agent Drug-Coated Balloon
Image courtesy of Boston Scientific

Boston Scientific today announced FDA approval of its Agent drug-coated balloon (DCB), making it the first coronary DCB indicated for in-stent restenosis (ISR) in patients with coronary artery disease in the United States.

ISR arises as a complication from implanting a stent in the heart and involves the accumulation of plaque or scar tissue under the stent, causing a previously opened heart vessel to narrow again. Current treatments for ISR include additional layers of stenting or radiation. Agent is a paclitaxel-coated balloon catheter designed to transfer a therapeutic dose of the drug to the vessel wall to help prevent ISR recurrence.

After receiving Breakthrough Device Designation in 2021, the recent approval was supported by results from the company’s multicenter, prospective, randomized controlled Agent IDE clinical trial. After enrolling 600 patients at 40 US sites, a pre-specified interim analysis of the first 480 patients showed that the primary endpoint of target lesion failure at 12 months with the Agent DCB demonstrating statistical superiority to uncoated balloon angioplasty was met. Additionally, findings also included zero definite/probable cases of clotting within the stent, a 49% risk reduction in heart attack at the target vessel, and low adverse event rates at 12 months.

Related:New Data Debunks Death Risk Warnings on Paclitaxel-Coated Devices

BTIG analysts reiterated their “buy” model after the news of the approval broke, citing the technologies global market opportunity and the statistical significance of the Agent IDE results.

“ISR accounts for roughly 10% of all PCI patients, representing a $500 [million] global market opportunity,” BTIG analysts Marie Thibault and Sam Eiber wrote. “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. Agent is already approved in Europe and Japan, and is expected to launch in China in 2025. Additional segments [Boston Scientific] is exploring beyond ISR include use in small vessels, bifurcations, and acute coronary syndrome, which account for another >20% of PCI patients. These remain compelling long-term market expansion opportunities which together represent a potential $1B global market.”

Boston Scientific said it plans to launch the technology in the US in the coming months.

"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 US," said Lance Bates, president of interventional cardiology therapies at Boston Scientific, in the press release announcing the approval. "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 US physicians the opportunity to treat their patients with this novel device."

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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