Abbott today announced it has received CE Mark in Europe for the Volt PFA System to treat patients battling atrial fibrillation (AFib). With the earlier-than-expected CE Mark, Abbott said it has begun commercial PFA cases in the EU with physicians who have already gained experience with the Volt PFA System within Abbott's PFA clinical studies. The company will further expand use of Volt in EU markets throughout the second half of the year.
CE Mark approval for the Volt PFA System was granted based on strong results from Abbott's Volt CE Mark study, a global clinical trial conducted at centers in Europe and Australia. The trial showed the Volt PFA System achieved pulmonary vein isolation (PVI) – the method of destroying tissue causing a patient's AFib – in 99.1% of veins during ablation procedures with far fewer energy applications than on-market competitive PFA systems.
"While PFA is a relatively new therapy option, we've incorporated lessons learned from first-generation devices and designed the Volt system to simplify PFA procedures while making them more efficient," said Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business. "Clinical data has also shown that the Volt catheter's cutting-edge design helps physicians achieve pulmonary vein isolation in fewer ablation attempts and less therapy applications for improved patient outcomes."
Clinical and Regulatory Progress Across Abbott's PFA PortfolioAbbott's Volt PFA System is currently under evaluation in the VOLT-AF Investigational Device Exemption (IDE) Study. The study completed enrollment last year – four months ahead of the anticipated timeline. Nearly 400 patients are enrolled in the trial, and Abbott anticipates completing the 12-month follow-up for the study later this year.
In addition, the company has also made progress in clinical studies evaluating Abbott's focal PFA technology, which is designed to provide focused energy delivery for the creation of targeted lesions at specific points in the heart. Enrollment was recently completed ahead of schedule in Abbott's FOCALFLEX CE trial assessing the performance of the TactiFlex Duo Ablation Catheter, Sensor Enabled. Enrollment is also underway in the FlexPulse IDE trial evaluating TactiFlex Duo in the U.S.
Abbott has also recently received regulatory approval in the U.S. and Europe for a 13F sizing of the company's Agilis NxT Steerable Introducer, Dual Reach, which makes the Agilis system compatible with larger catheters, including those used for PFA therapy.
