Abbott announced the completion of patient enrolment for its VOLT-AF IDE Study, which supports the company’s Volt Pulsed Field Ablation (PFA) system.
This study, completed four months ahead of schedule, enrolled nearly 400 patients in three months and aims to evaluate the system’s efficacy in treating atrial fibrillation (AFib).
According to the American medical device firm, the Volt PFA System is being developed as an alternative ablation tool that uses electrical pulses rather than traditional heat or cold methods to treat patients with abnormal heart rhythms.
The Volt PFA System, which pairs a balloon-in-basket catheter with Abbott’s EnSite X EP System, was designed to address limitations of earlier PFA systems.
Traditional systems have faced issues such as the lack of three-dimensional visualisation and difficulties with catheter-tissue contact. Abbott’s system aims to overcome these challenges by improving catheter stability and contact during the procedure.
In a parallel development, Abbott has launched the FOCALFLEX trial to assess the performance of the TactiFlex Duo Ablation Catheter, Sensor Enabled (SE). This trial will focus on evaluating the catheter’s ability to deliver dual-energy treatment, combining both PFA and radiofrequency (RF) energy.
The catheter is designed to treat patients with paroxysmal atrial fibrillation and offers more flexible treatment options by allowing physicians to use either PFA or RF depending on the specific needs of the case.
It is built upon the TactiFlex Ablation Catheter, Sensor Enabled, which is designed with a flexible tip to enhance stability during procedures. The dual-energy system allows physicians to deliver more focused and flexible energy to targeted areas within the heart, said Abbott.
The FOCALFLEX trial will assess the safety and effectiveness of the TactiFlex Duo Catheter in delivering both PFA and RF energy, with a focus on providing physicians with more versatile tools for treating AFib. The catheter is expected to be further evaluated in the upcoming FLEXPULSE IDE trial in the US, which will involve approximately 200 patients across 25 clinical sites.
University of Adelaide, Australia Centre for Heart Rhythm Disorders director Prash Sanders carried out the first procedures with the TactiFlex Duo Ablation Catheter, Sensor Enabled for the FOCALFLEX trial.
Sanders said: “There’s immense value in exploring different therapy options for patients to treat abnormal heart rhythms because each case is unique.
“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.”
Abbott had also received clearance from the US Food and Drug Administration (FDA) for its Advisor HD Grid X Mapping Catheter, Sensor Enabled. This technology is designed to support improved mapping in both PFA and RF ablation cases, where accurate visualisation of the heart’s anatomy is critical for achieving optimal outcomes during ablation procedures.
In August 2024, Abbott announced that the FDA had approved a labelling update for its HeartMate 3 heart pump, permitting the removal of aspirin from routine patient management. The implantable left ventricular assist device (LVAD) has also received approval for this update from regulatory agencies in Canada and the European Union.
