Abbott has reached two milestones in a pair of trials evaluating the company’s pulsed field ablation (PFA) technology for the treatment of abnormal heart rhythms.
The first milestone came in the form of enrollment in the VOLT-AF study, which Abbott said happened ahead of time. The VOLT-AF study, being conducted under investigational device exemption (IDE), is evaluating Abbott’s VOLT PFA system for the treatment of atrial fibrillation (AF).
Abbott's device was designed to overcome prior limitations in PFA systems by pairing a balloon-in-basket catheter with an in-house heart mapping solution. The company states the design leads to better catheter contact and stability during the procedure.
PFA is touted as a new treatment paradigm for patients with AF, with the technology earmarked as an advancement over its counterpart – thermal ablation. Unlike heat – or cold energy in the case of cryoablation – PFA uses short bursts of electrical energy to kill off heart tissue associated with AF.
The VOLT PFA system has already demonstrated positive results in a feasibility study for CE marking in Europe. Acute effectiveness was achieved in 99.2% of treated pulmonary veins, with no serious adverse events.
Abbott’s other bit of clinical news is that its global FOCALFLEX Pulsed Field Ablation Study is also now underway, assessing the TactiFlex Duo Ablation Catheter. This catheter is designed with dual-energy ablation, delivering both PFA and radiofrequency to tissue. The technology will also be assessed in the FLEXPULSE IDE, which Abbott says will launch in the US soon, with around 200 patients at 25 sites. TactiFlex works via a focal PFA approach, unlike Volt’s single shot technique, and according to Abbott is developed offer physicians greater versatility in targeting heart tissue.
In the same press release announcing the study advancements, Abbott unveiled that its Advisor HD Grid X Mapping Catheter won US Food and Drug Administration (FDA) clearance. Mapping is becoming a key part of PFA procedures to guide energy delivery and improve success rates.
While Europe has had PFA systems since 2021 – Medtronic, Johnson & Johnson (J&J), and Boston Scientific all have systems marketed in the regions – the US only received its first regulatory late last year.
Medtronic won the first approval for its PulseSelect in December 2023. A month later Boston Scientific joined the PFA arena with Farapulse. Both systems have enjoyed a swift uptake, though analysis by GlobalData shows that Boston Scientific’s system is enjoying a better market share.
