Abbott received FDA clearance for its latest-generation catheter, which gives physicians more flexibility in treating atrial fibrillation.
Dubbed the TactiFlex Duo, the ablation catheter is sensor-enabled and can use pulsed field ablation, radio frequency energy or a combination of both during the procedure that targets the tissue responsible for abnormal electrical signals in the heart, the company said.
When combined with Abbott’s EnSite X EP System, it can give real-time feedback as an integrated mapping solution with the PFA Index (PI), a tool that assesses lesion formation during ablation with TactiFlex Duo.
According to statistics cited by Abbott, an estimated 10.5 million people in the U.S. have a heart that either beats too fast, too slow or at an irregular pace that can lead to serious complications, including stroke.
"Electrophysiology is rapidly evolving as physicians adopt new technologies that improve the safety and effectiveness of AFib treatment," Atul Verma, M.D., the director of cardiology at the McGill University Health Centre in Montreal, said in a statement. “TactiFlex Duo provides physicians with greater flexibility during procedures.”
Approval by the U.S. regulatory agency was based on Abbott’s FlexPulse Identity study that showed favorable outcomes in patients with paroxysmal AFib (irregular heart rhythm episodes that come and go).
Rollout of the device in the U.S. is expected to begin in the coming week, Abbott said, noting that the approval represents the fifth of its electrophysiology nods in just over a year, including EU regulatory green lights for Amulet 360, TactiFlex Duo CE Mark and the Volt PFA system.
“By continuing to expand our PFA portfolio and integrate innovative technologies across cardiovascular care, we're helping physicians navigate increasingly complex procedures while ensuring more patients receive the right care at the right time,” said Uri Yaron, the SVP of Abbott’s electrophysiology unit.