Abbott, the global healthcare leader, announced it has received U.S. Food and Drug Administration (FDA) approval for the TactiFlex Duo Ablation Catheter, sensor-enabled, to treat patients with challenging cases of atrial fibrillation (AFib). The U.S. approval of this dual-energy catheter, the latest generation of Abbott's cardiac ablation technology, marks a significant milestone in Abbott's commitment to advancing therapies that help physicians treat complex heart rhythms with greater precision and flexibility. Abbott will soon begin cases with broader commercial adoption across the country in the coming weeks.
For the 10.5 million people in the U.S. who live with a heart that beats too fast, too slow or in an irregular way, treatment is critical as AFib increases the risk of serious complications, including stroke. While many people are treated with medications, others require cardiac ablation, a minimally invasive procedure that targets the tissue responsible for abnormal electrical signals in the heart.
TactiFlex Duo is Abbott's latest ablation catheter designed to give physicians more flexibility when treating AFib. The 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. The dual-energy approach means physicians can create precise therapeutic lesions, or small areas of scar tissue, that block the abnormal electrical signals causing an irregular heartbeat while helping minimize 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 AFib.
"Electrophysiology is rapidly evolving as physicians adopt new technologies that improve the safety and effectiveness of AFib treatment," said Atul Verma, M.D., Director of Cardiology at the McGill University Health Centre in Montreal, Canada, and a globally recognized expert in pulsed field ablation technology. "TactiFlex Duo provides physicians with greater flexibility during procedures, and when it is combined with the high-resolution 3D visualization available through Abbott's EnSite X mapping system, physicians have a suite of practice-changing tools to confidently treat patients with complex AFib."
