Abbott has announced it has received US Food and Drug Administration (FDA) approval to treat patients with challenging cases of atrial fibrillation (AF) using its sensor-enabled TactiFlex Duo ablation catheter.
US approval of this dual-energy catheter—the latest generation of Abbott’s cardiac ablation technology—marks a significant milestone in the company’s commitment to advancing therapies that help physicians treat complex heart rhythms with greater precision and flexibility, as stated in a press release.
Abbott will soon begin cases with broader commercial adoption across the country in the coming weeks.
According to Abbott, this technology allows physicians to use pulsed field ablation (PFA), radiofrequency (RF) energy or a combination of both during a procedure, helping them tailor treatment to each patient’s needs. Abbott’s EnSite X EP system also provides physicians with real-time feedback as an integrated mapping solution with the PFA Index (PI)—a tool designed to assess lesion formation during ablation with TactiFlex Duo.
Additionally, the dual-energy approach means physicians can create precise therapeutic lesions that block the abnormal electrical signals causing an irregular heartbeat while helping to minimise the impact on surrounding healthy tissue. Successfully treating these areas can help restore the heart’s normal rhythm and improve outcomes for patients living with AF.
“Electrophysiology [EP] is rapidly evolving as physicians adopt new technologies that improve the safety and effectiveness of AF treatment,” said Atul Verma (McGill University Health Centre, Montreal, Canada). “TactiFlex Duo provides physicians with greater flexibility during procedures and, when it is combined with the high-resolution 3D visualisation available through Abbott’s EnSite X mapping system, physicians have a suite of practice-changing tools to confidently treat patients with complex AF.”
The US FDA approval of TactiFlex Duo was secured based on the results from Abbott’s FlexPulse investigational device exemption (IDE) study.
“TactiFlex Duo represents an important advancement as Abbott builds the industry’s most comprehensive electrophysiology portfolio,” commented Uri Yaron, senior vice president of Abbott’s electrophysiology business. “From diagnosis, mapping and intracardiac ultrasound imaging to advanced treatments for the most complex arrhythmias, Abbott is uniquely positioned to support physicians at every stage of patient care. 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.”
