MedTech Dive March 1, 2024
Susan Kelly

BTIG analyst Marie Thibault said physicians could rapidly adopt the first-of-its-kind device.

Dive Brief:

  • Boston Scientific said Friday it has received Food and Drug Administration approval for a drug-coated balloon to treat coronary in-stent restenosis, a condition in which a vessel that previously received a stent narrows again due to plaque or scar tissue.
  • Approval for the device, which received FDA’s breakthrough designation in 2021, was supported by positive results from the prospective, randomized Agent trial that enrolled 600 patients at 40 U.S. sites, the company said.
  • “We view Agent highly favorably for its statistically significant superiority in what is a difficult-to-treat and common [in-stent restenosis] patient population, which we think could enable rapid physician adoption,” BTIG analyst Marie...

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Topics: FDA, Govt Agencies, Medical Devices, Physician, Provider
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