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Abbott gains FDA clearance for dual-energy AFib catheter

PR Newswire ·
Abbott gains FDA clearance for dual-energy AFib catheter
  • TactiFlex Duo combines pulsed-field ablation and radiofrequency energy in one catheter, allowing physicians to use either modality or both during AFib procedures.
  • Abbott said the FDA approval was supported by FlexPulse IDE study data showing favorable safety and effectiveness outcomes in patients with paroxysmal AFib.
  • The approval is Abbott's fifth major electrophysiology approval in just over a year and expands its pulsed-field ablation portfolio.

Quotes

“TactiFlex Duo provides physicians with greater flexibility during procedures, and when it is combined with the high-resolution 3D visualization available through Abbott's EnSite X mapping system, physicians have a suite of practice-changing tools to confidently treat patients with complex AFib.”— Atul Verma, M.D.
“TactiFlex Duo represents an important advancement as Abbott builds the industry's most comprehensive electrophysiology portfolio.”— Uri Yaron

Sources

Abbott gains FDA clearance for dual-energy AFib catheter — Heurist Finance