Abbott has received an FDA clearance for the latest version of its sensor-laden catheter used to map out the electrical activity of the heart muscle—a device the company says will help support its upcoming ablation devices for treating atrial fibrillation, each of which are making their own progress in clinical studies.
That includes Abbott’s entry in the arena of pulsed field ablation, the Volt system, which completed its enrollment of a U.S. pivotal study four months ahead of schedule, the company said, after signing up nearly 400 participants in about 90 days.
Abbott also offered an update on the development of its sensor-enabled TactiFlex Duo, reporting the launch of a clinical study to assess the catheter’s ability to deliver both pulsed field and traditional radiofrequency energy ablation.
But first, commercial work will get underway for the Advisor HD Grid X mapping catheter, an upgrade over previous models cleared by the FDA in 2018 and 2020. With a paddle-shaped design carrying 16 electrodes, the catheter is used with Abbott’s EnSite X ablation navigation system—the 3D platform that will eventually come bundled with the Volt.
Pulsed field ablation aims to address afib without the complications that can come with thermal approaches, where excess heat or cold can damage nearby healthy tissues and organs. Instead, it relies on tuned bursts of electric fields that destabilize specific cardiac muscle cells while sparing others.
However, Abbott said some of the technology’s first forays have lacked features such as 3D visualization of the atria and ventricles, as well as live feedback of the catheter coming into contact with the heart tissue, two things it aims to provide.
While the Volt aims to provide a single-shot ablation approach, using a balloon-in-basket design to isolate the pulmonary veins, the TactiFlex Duo is built for focal or point-by-point ablation, allowing it to tackle unique cases of abnormal heart rhythms by targeting specific areas of the heart with its flexible tip.