Surgeries & Interventions

Boston Scientific AGENT Drug-Coated Balloon Lands Long-Awaited FDA Approval

The United States has been way behind other nations in using drug-coated balloons (DCB) to treat coronary in-stent restenosis (ISR), but that’s about to change thanks to the FDA approval of Boston Scientific’s AGENT Drug-Coated Balloon. 

  • Boston Scientific’s AGENT DCB is a paclitaxel-coated balloon catheter, designed to re-open ISR vessels and then transfer the drug to the vessel wall to help prevent ISR reoccurrence (which happens w/ 10% of PCIs).
  • AGENT DCB already has regulatory approval in Europe, Latin America, and Asia, already treating 100k global patients before its US launch in the coming months.
  • The AGENT DCB is widely supported for its ability to address an unmet need for US cardiologists and patients, who have been limited to less-effective ISR treatments like repeat balloon angioplasty or additional stent layers.

Boston Scientific’s AGENT DCB FDA approval stands on the shoulders of its stellar AGENT IDE Trial results, which were met with applause at TCT 2023 after showing perhaps the strongest evidence yet that DCBs are safe, effective, and superior to balloon angioplasty. 

The study included 480 patients with ISR, finding that after one year the AGENT DCB was far superior to balloon angioplasty for…

  • Target lesion failure (17.9% vs. 28.7%, the primary endpoint)
  • Target lesion revascularization (12.4% vs. 24.0%) 
  • Target vessel myocardial infarction (6.4% vs 12.3%)
  • Stent thrombosis (0.0% vs. 3.9%)

This data and the AGENT DCB’s long-awaited FDA approval earned praise from interventional cardiologists and the investment community (not to mention Boston Scientific), with most believing that the DCB could gain much quicker and stronger adoption than many new therapies.

  • It also turned attention to AGENT DCB’s potential to expand beyond ISR treatment, including bifurcation lesions, ACS, diffuse LAD disease, and small vessels.

The Takeaway
Except for the fact that the AGENT DCB’s FDA approval came 10 whole years after its EU CE Mark, it launches in the US in an ideal situation, noting that it should see strong clinical demand (again, ISR happens in 10% of all PCIs) and it’s supported by solid research and clinical evidence.

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