Dive Brief:
- FDA Approval: Abbott announced that it has received FDA approval for the TactiFlex Duo catheter, which combines pulsed field ablation (PFA) and radiofrequency (RF) energy to treat atrial fibrillation (AFib). This allows physicians to customize treatments by switching between the energy modes.
- Market Impact: The device, which received the CE mark in Europe earlier this year, is expected to boost Abbott’s sales in the electrophysiology market, according to CEO Robert Ford.
- Study Results: The U.S. approval follows the presentation of results from the FlexPulse IDE study at the European Society of Cardiology Congress, highlighting the safety and effectiveness of TactiFlex Duo in treating paroxysmal AFib.
Dive Insight:
- Understanding AFib: AFib is the most prevalent heart arrhythmia and heightens the risk of blood clots, potentially leading to strokes. Effective treatment can prevent the progression of AFib.
- Ablation Techniques: RF ablation uses heat to create lesions that block abnormal electrical signals, while PFA employs electrical pulses to create scars, reducing the risk of injury to surrounding tissues. PFA has gained popularity as companies introduce advanced systems.
- Market Expectations: Abbott’s portfolio includes the next-gen Volt PFA catheter, expected to help the company reclaim market share and boost sales significantly in the electrophysiology sector. Volt has also gained approvals in the U.S. and Europe slated for 2025.
- Future Plans: Abbott plans to initiate procedures with TactiFlex Duo in the U.S. shortly.
