Boston Scientific has received the US Food and Drug Administration (FDA) approval for the Agent Drug-Coated Balloon (DCB) to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.
The Agent DCB is a balloon catheter coated with paclitaxel that delivers a therapeutic dose of medication to the vessel wall, helping to avoid ISR recurrence.
It can be used as an alternative to conventional procedures such as balloon angioplasty, additional layers of stenting, or radiation.
The Agent DCB is now said to be the first coronary drug-coated balloon in the US to offer safe, effective options in ISR treatment.
The approval follows the FDA’s Breakthrough Device Designation for the technology in 2021.
Boston Scientific interventional cardiology therapies president Lance Bates said: “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.
“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.”
The approval was based on the positive results from the multicentre, prospective, randomised controlled Agent IDE study. It recruited 600 patients at 40 US sites.
The trial met its primary endpoint of target lesion failure (TLF) at 12 months in the prespecified interim analysis of the first 480 enrolled patients.
Agent DCB showed statistical superiority to uncoated balloon angioplasty.
Other findings were low adverse event rates at 12 months, a 49% reduction in the risk of a heart attack at the target vessel, and zero definite/probable cases of clotting within the stent.
Patients with ISR and untreated small artery coronary disease can receive Agent DCB in Europe, certain regions of Asia Pacific, and Latin America.
Boston Scientific intends to introduce the technology to the American market in the upcoming months.
Last month, the medical device company secured the FDA’s expanded approval for the WaveWriter spinal cord stimulation (SCS) systems.
