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Abbott Reports the Study Advancements in Pulsed Field Ablation, Gets the US FDA’s Nod for Technology Supporting Cardiac Mapping

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Abbott Reports the Study Advancements in Pulsed Field Ablation, Gets the US FDA’s Nod for Technology Supporting Cardiac Mapping

Shots:

  • Abbott has completed the recruitment of 400 subjects in VOLT-AF IDE trial of Volt PFA System, ahead of schedule & reported the US FDA’s approval of Sensor Enabled (SE), Advisor HD Grid X Mapping Catheter that enhances cardiac anatomy visualization during both PFA & radiofrequency ablation, improving outcomes for ablation procedures
  • The company has begun FOCALFLEX study of SE, TactiFlex Duo Ablation Catheter to treat paroxysmal Afib. It will also be assessed under FLEXPULSE IDE study of 200 subjects, to be started in 25 US sites
  • The Volt PFA System is a single-shot method for PFA, while the TactiFlex Duo is a point-by-point method for focused delivery of both PFA/radiofrequency (RF) energy, targeting specific heart tissue with greater accuracy

Ref: Abbott | Image: Abbott

Related News: Abbott Reports the Initiation of TRANSCEND Trial Assessing Deep Brain Stimulation System to Manage Severe Depression (TRD)

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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