Abbott, the global healthcare leader, has announced new late-breaking 12-month data from the FlexPulse Global IDE study that show favourable safety and effectiveness outcomes for its investigational TactiFlex Duo Ablation Catheter, Sensor Enabled, to treat patients with challenging cases of atrial fibrillation (AFib).
The results were presented in a late-breaking session at the European Society of Cardiology (ESC) Congress in Munich, Germany, last month, and simultaneously published in EP Europace.
TactiFlex Duo is a dual-energy catheter designed to give physicians more flexibility when treating AFib. The investigational technology offers both pulsed field ablation (PFA) and radiofrequency (RF) energy approaches to treatment, which can help a physician tailor therapy to a patient’s individual 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.
Both PFA and RF are used to create 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.
The 12-month data presented at ESC showed positive outcomes in patients with paroxysmal atrial fibrillation (irregular heart rhythm episodes that come and go).
The study met its primary effectiveness endpoint, with 74.6% of patients remaining free from documented arrhythmias, medication changes, or repeat procedures.
The study reported a consistently high patient safety profile (98.3%) with no major safety events.
