Abbott announced the early completion of enrollment in its VOLT-AF IDE study supporting the Volt PFA (pulsed field ablation) system. The company also launched the FOCALFLEX trial to assess its TactiFlex Duo Ablation Catheter, Sensor Enabled (SE), which will be used to treat patients with paroxysmal atrial fibrillation (AFib).
 
Increased interest in Abbott’s PFA system propelled enrollment in the U.S. VOLT-AF IDE study to be completed four months ahead of the anticipated timeline, enrolling nearly 400 patients in three months.
 
In addition, Abbott also revealed U.S. Food and Drug Administration (FDA) clearance of its Advisor HD Grid X Mapping Catheter, Sensor Enabled to further support mapping of both PFA and radiofrequency (RF) ablation cases, where visualization of cardiac anatomy is critical.
 
Abbott’s investigational Volt PFA system was designed to overcome prior limitations in PFA systems by pairing a balloon-in-basket catheter with Abbott’s EnSite X EP System, a heart mapping solution. The unique basket shape of the catheter’s energy delivery area paired with the balloon are designed to effectively transfer Abbott’s optimized waveform energy to the tissue by ensuring better catheter contact and stability during the procedure.
 
Another unique feature of Abbott’s PFA catheter is how the platform’s PFA generator and the EnSite X EP System are designed to give physicians the ability to specifically target lesions and ablate the exact area(s) of the heart triggering arrhythmia.
 
The TactiFlex Duo Ablation Catheter, Sensor Enabled is a dual-energy ablation solution for both PFA and RF energy delivery. It will also be assessed in the FLEXPULSE IDE, which is expected to launch in the U.S. soon, with about 200 patients at 25 sites.
 
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. Designed on Abbott’s TactiFlex Ablation Catheter, Sensor Enabled, known for its stability during procedures due to its novel flexible tip, the TactiFlex Duo Ablation Catheter, SE aims to offer physicians another option for delivering PFA and/or RF to patients with greater versatility to precisely target specific areas of tissue within the heart.
 
With its recent FDA clearance, the Abbott Advisor HD Grid X Mapping Catheter, Sensor Enabled, offers a first-of-its-kind electrode configuration for high-density heart mapping. This design is intended to make physicians more aware of electrical signals of the heart, regardless of catheter placement during an ablation procedure.
 
“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, MD, 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.”
 
“There’s immense value in exploring different therapy options for patients to treat abnormal heart rhythms because each case is unique,” said professor 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. “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.”