Abbott Advances in Pulse Field Ablation with New Mapping Tools and Clinical Trial Milestones
Abbott
Diagnostic and pharmaceutical product manufacturers
Recently, Abbott announced new milestones supporting its electrophysiology pulsed field ablation (PFA) solutions suite.
The company completed enrollment in the VOLT-AF FDA Investigational Device Exemption (IDE) study, evaluating the Volt PFA System ahead of schedule. It also initiated the FOCALFLEX trial to assess its TactiFlex dual ablation catheter with Sensor-Enabled (SE) technology. The company stated that these two studies mark significant progress toward the future of its two PFA catheters.
Moreover, Abbott announced that its Advisor HD Grid X Mapping Catheter SE has received FDA approval for use in PFA and radiofrequency (RF) ablation. The company stated that this supports critical visualization of cardiac anatomy during ablation procedures.
"Exploring different treatment options for arrhythmia is of great value because every case is unique," said Prash Sanders, Director of the Arrhythmia Center at the University of Adelaide in Australia. ， HeUseTactiFlex Duo Ablation Catheter SE Performs First Procedure for FOCALFLEX Trial. "Abbott has improved the limitations of the first-generation system and successfullyPFA"The method has been pushed to the level of those initial systems on the market."
More Information on Abbott's Advanced Ablation Technology
Volt Marks Abbott's Entry Into the Crowded Pulsed Field Ablation (PFA) Space. Companies like Medtronic, Boston Scientific, and Johnson & Johnson's Biosense Webster all offer their own PFA technologies for treating AFib. AbbottReported Volt's first global surgery in January。
Abbott Designs Volt to Address Limitations of Existing PFA Technology. It pairs a basket balloon catheter with the EnSite X EP cardiac mapping system. EnSite X assists physicians in visualizing and navigating tools like the Volt PFA catheter within the heart. Abbott states that this design allows for more precise ablation procedures, providing doctors with clearer guidance on how to better contact targeted cardiac tissue.
Abbott Reports Growing Interest in Its PFA System, Completing Enrollment Four Months Ahead of Schedule; Study Enrolls Nearly 400 Patients in Just Three Months
Growing interest in Abbott's PFA system has driven the early completion of patient enrollment for the U.S. VOLT-AF IDE study by four months, with nearly 400 patients recruited in just three months.
As the FOCALFLEX study progresses, researchers are also considering the TactiFlex Duo catheter as a dual-energy ablation solution. The catheter provides a "focal" or "point-by-point" approach, delivering PFA safety and efficiency with more flexibility and focused energy. Abbott also expects to soon launch an IDE study in the U.S. for this technology, evaluating approximately 200 patients across 25 sites.
Finally, the company stated that its new mapping catheter provides a first-of-its-kind high-density cardiac mapping electrode configuration. Abbott designed the catheter with the aim of...It allows doctors to better understand the heart's electrical signals during the ablation process, regardless of where the catheter is placed.
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