Abbott has achieved key milestones in its pulsed field ablation (PFA) program, including the completion of enrollment for the VOLT-AF IDE study and the launch of the FOCALFLEX trial. These developments support Abbott's PFA solutions for electrophysiology, aimed at improving the treatment of atrial fibrillation (AFib).
VOLT-AF IDE Study Completion
The VOLT-AF IDE study, designed to evaluate Abbott's Volt PFA System, completed enrollment ahead of schedule. The trial enrolled almost 400 patients in three months, reflecting strong interest in Abbott's PFA technology. Monica Lo, M.D., an electrophysiologist with Arkansas Heart Hospital, noted the excitement around assessing a next-generation PFA catheter with new design concepts expected to advance PFA technology and improve patient outcomes.
FOCALFLEX Trial Launch
Abbott has also initiated the global FOCALFLEX Pulsed Field Ablation Study to assess the TactiFlex Duo Ablation Catheter, Sensor Enabled. This catheter is designed as a dual-energy ablation solution, offering both PFA and radiofrequency (RF) energy delivery. The FLEXPULSE IDE, a related study, is expected to launch soon in the US, involving approximately 200 patients across 25 sites.
Prash Sanders, M.B.B.S., Ph.D., director of the Centre for Heart Rhythm Disorders at the University of Adelaide in Australia, who conducted the first procedures with the TactiFlex Duo Ablation Catheter, Sensor Enabled, for the FOCALFLEX trial, emphasized the value in exploring different therapy options for patients to treat abnormal heart rhythms because each case is unique. He added that Abbott improved upon limitations of first-generation systems and has successfully advanced its approach to PFA beyond those initial systems that have come to market.
FDA Clearance for Advisor HD Grid X Mapping Catheter
Abbott received FDA clearance for its Advisor HD Grid X Mapping Catheter, Sensor Enabled. This technology supports mapping for both PFA and RF ablation cases, where visualization of cardiac anatomy is critical for optimal outcomes. The catheter features a first-of-its-kind electrode configuration for high-density heart mapping, enhancing physicians' awareness of electrical signals in the heart, regardless of catheter placement during ablation.
Advancing PFA Technology
Pulsed field ablation represents a promising alternative to traditional RF or cryogenic ablation for treating abnormal heart rhythms. PFA uses high-energy electrical pulses to destroy cells causing arrhythmias, potentially reducing the risk of damage to adjacent tissues. Abbott's PFA systems address limitations of earlier PFA technologies, such as the lack of 3D visualization and integration with cardiac mapping systems. The Volt PFA System pairs a balloon-in-basket catheter with Abbott's EnSite X EP System, a heart mapping solution, to improve catheter contact and stability during procedures. The system is designed to enable precise targeting of lesions and ablation of specific areas triggering arrhythmia.
Where the Volt PFA System is designed as a "single shot" PFA approach, the TactiFlex Duo Ablation Catheter, SE is a "focal" or "point-by-point" approach that aims to deliver the safety and efficiency of PFA with more flexible and focused energy.
With these advancements, Abbott aims to refine PFA technology, improve treatment precision, and enhance outcomes for patients with atrial fibrillation and other complex heart rhythm conditions.
