Abbott official posted on social media to announce FDA breakthrough device designation for a new ablation catheter.
Abbott SVP Uri Yaron said on LinkedIn that the FDA granted the breakthrough nod for the TactiFlex Duo Sensor-Enabled catheter for the treatment of ventricular tachycardia (VT) using pulsed field ablation (PFA). The catheter features a dual-energy modality for treating VT using pulsed field ablation (PFA).
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“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 marks the latest development for Abbott in its pursuit to enter the competitive PFA market. It could join the likes of Medtronic, Boston Scientific and Johnson & Johnson MedTech, as well as several others.
Abbott continues to progress its Volt single-shot PFA system, while TactiFlex Duo marks a different type of entry. The “focal” or “point-by-point” approach used for TactiFlex Duo aims to deliver PFA with more flexible and focused energy. With a novel flexible tip, the dual-energy system can deliver PFA or radiofrequency (RF) ablation with greater versatility to precisely target specific areas of tissue within the heart.
TactiFlex Duo could rival J&J MedTech’s ThermoCool dual-ablation catheter.
