Abbott has received a Breakthrough Device Designation from the U.S. FDA for its innovative TactiFlex Duo Sensor-Enabled catheter, designed for the treatment of ventricular tachycardia (VT) using pulsed field ablation (PFA) technology.
In a LinkedIn post, Abbott Senior Vice President Uri Yaron announced the milestone, highlighting that the catheter introduces a dual-energy modality capable of delivering both PFA and radiofrequency (RF) ablation.
“To qualify for this breakthrough designation, products must address an unmet need and show it has the potential to provide more effective treatment of life-threatening diseases,” Yaron wrote. “This is at the heart of what we do at Abbott. This milestone represents years of dedication in developing innovations that support physicians as they treat patients with complex arrhythmias.
“Chapeau to our Abbott teams and clinical collaborators as we continue pushing forward to bring this advancement to patients as soon as possible.”
This development underscores Abbott’s growing footprint in the competitive PFA market, where it joins leading players such as Medtronic, Boston Scientific, and Johnson & Johnson MedTech.
While the company continues to advance its Volt single-shot PFA system, the TactiFlex Duo represents a “focal” or “point-by-point” ablation approach—designed to offer greater precision and flexibility in treating targeted heart tissue. The catheter’s novel flexible tip enhances control, enabling physicians to precisely tailor ablation therapy.
With its dual-energy design, TactiFlex Duo positions Abbott to potentially rival J&J MedTech’s ThermoCool dual-ablation catheter, signaling the company’s strong commitment to advancing next-generation arrhythmia treatment technologies.