The company completed enrollment early for its VOLT-AF FDA investigational device exemption (IDE) study evaluating the Volt PFA system. It also launched its FOCALFLEX trial to assess its TactiFlex duo ablation catheter, Sensor-Enabled (SE). The company said these two studies mark significant advances for the future of its two PFA catheters.
Additionally, Abbott reported FDA clearance for its Advisor HD Grid X mapping catheter, SE, for both PFA and radiofrequency (RF) ablation. The company said this supports the critical visualization of cardiac anatomy in ablation procedures.
“There’s immense value in exploring different therapy options for patients to treat abnormal heart rhythms because each case is unique,” said Prash Sanders, 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, SE 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.”
More about the advancing ablation tech at Abbott
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. Abbott reported the first global procedures for Volt in January.
The company designed Volt to address the limitations of existing PFA technologies. It paired a balloon-in-basket catheter with the EnSite X EP heart mapping system. Ensite X helps physicians visualize and position tools like the Volt PFA catheter in the heart.
To further maximize efficient energy transfer into the heart tissue, Abbott created a device with electrodes that only face outward and insulated nitinol splines that are flat, not round.
According to Abbott, the Volt system’s design can lead to more accurate ablation procedures with physicians given a clearer indication to make improved contact with targeted heart tissue. (On Medical Design & Outsourcing: Abbott bets on balloons in pulsed field ablation battle)
Abbott reported increased interest in its PFA system, propelling the completion of enrollment four months ahead of the anticipated timeline. The study enrolled nearly 400 patients in just three months.
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 almost 400 patients in just three months.
With the FOCALFLEX study underway, too, investigators are looking at the TactiFlex Duo catheter as a dual-energy ablation solution. This catheter offers a “focal,” or “point-by-point” approach, delivering the safety and efficiency of PFA with more flexible and focused energy. Abbott also expects to launch an IDE study for this technology in the U.S. soon, evaluating around 200 patients across 25 sites.
Finally, the company says its new mapping catheter offers a first-of-its kind electrode configuration for high-density heart mapping. Abbott designed it to make physicians more aware of electrical signals of the heart, regardless of catheter placement during an ablation procedure.
