SHERIDAN, WYOMING – November 07, 2024 – Abbott (NYSE: ABT) today announced significant strides in its pulsed field ablation (PFA) solutions within the electrophysiology field. The company has achieved key milestones, including the early completion of enrollment in the VOLT-AF IDE Study for the Volt™ PFA System and the initiation of the FOCALFLEX trial to evaluate the TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ (SE), designed for treating paroxysmal atrial fibrillation. These advancements underscore Abbott's commitment to providing innovative solutions for abnormal heart rhythms like atrial fibrillation (AFib).
In addition, Abbott has received U.S. Food and Drug Administration (FDA) clearance for the Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, further enhancing cardiac mapping capabilities for both PFA and radiofrequency (RF) ablation procedures.
"It was exciting to participate in the VOLT-AF IDE Study to help assess a next-generation PFA catheter that incorporates new design concepts we believe will advance PFA technology and improve patient outcomes," said Monica Lo, M.D., an electrophysiologist with Arkansas Heart Hospital who specializes in complex arrhythmias. "Only through studies like VOLT-AF and Abbott's new FOCALFLEX trial, can we fully understand and safely deploy the next generation of AFib treatments to help people enjoy life free from complex heart rhythm conditions."
A New Era in Pulsed Field Ablation for AFib Treatment
Cardiac ablation procedures traditionally relied on RF ablation, using heat to destroy erratically signaling tissues, or cryogenic ablation, which freezes them. PFA, however, employs high-energy electrical pulses to eliminate these cells, potentially reducing damage to surrounding tissues.
While PFA offers a promising approach to treating abnormal heart rhythms with enhanced safety, early-generation systems had limitations, including the lack of three-dimensional visualization and compatibility with 3D cardiac mapping systems. Abbott's PFA systems address these limitations by providing catheter-tissue contact indication and enabling repeat ablations for improved patient outcomes.
The U.S. VOLT-AF IDE Study, completed four months ahead of schedule with nearly 400 patients enrolled in just three months, reflects the growing interest in Abbott's PFA system.
Abbott's investigational Volt PFA System pairs a balloon-in-basket catheter with the EnSite™ X EP System, a leading heart mapping solution. The catheter's unique basket shape and balloon design optimize energy transfer to the tissue, ensuring better contact and stability during procedures. The platform's PFA generator, integrated with the EnSite X EP System, allows physicians to precisely target and ablate the heart areas triggering arrhythmia.
Alongside the VOLT-AF IDE Study, Abbott's global FOCALFLEX Pulsed Field Ablation Study is evaluating the TactiFlex Duo Ablation Catheter, SE. This dual-energy ablation catheter, offering both PFA and RF energy delivery, will also be assessed in the upcoming FLEXPULSE IDE study in the U.S., involving approximately 200 patients at 25 sites.
The Volt PFA System offers a "single shot" PFA approach, while the TactiFlex Duo Ablation Catheter, SE provides a "focal" or "point-by-point" method, delivering ablation energy focally. This focal approach aims to further minimize unnecessary damage to surrounding cells and tissues.
Abbott's Advisor HD Grid X Mapping Catheter, SE, recently cleared by the FDA, is designed to support both PFA and RF ablation cases. This advanced mapping catheter provides detailed visualization of cardiac anatomy, crucial for successful ablation procedures and improved patient outcomes.
Abbott's advancements in PFA technology and cardiac mapping demonstrate its dedication to providing innovative solutions for electrophysiology. These developments hold the potential to revolutionize the treatment of abnormal heart rhythms, offering new hope for people seeking to live free from complex heart rhythm conditions.