Abbott has started participant enrolment into the TactiFlex PAF IDE clinical study of its new catheter device for the treatment of paroxysmal atrial fibrillation (PAF).
Named TactiFlex Ablation Catheter, Sensor Enabled (SE), the device will be tested in patients who had no adequate response to medication for their atrial fibrillation (AFib) symptoms.
The study will involve 355 patients at several sites globally. Participants will undergo an ablation procedure, using Abbott’s new device.
Data from the study will be included in global regulatory submissions.
Tools such as contact force technology are used during ablation procedures to support physicians in applying the right amount of pressure to the heart tissue.
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In addition, physicians use magnetically sensor-enabled technology for precise location and navigation within the heart.
The Royal Adelaide Hospital Centre for Heart Rhythm Disorders director Prash Sanders said: “The TactiFlex device builds on prior generations of successful technology, giving me confidence that Abbott will continue providing options to effectively treat people living with recurrent episodes of atrial fibrillation.”
Abbott noted that the TactiFlex PAF IDE trial is part of its product-focused activities to improve patient care and cater to the needs of electrophysiologists.
Recently, the company received the US Food and Drug Administration (FDA) and European CE-Mark approval for the EnSite LiveView Dynamic Display.
LiveView enables real-time visualisation of data from the Advisor HD Grid mapping catheter during cardiac ablation.
Abbott electrophysiology and heart failure businesses senior vice-president Mike Pederson said: “Abbott is focused on bringing innovation to physicians that can improve how people with atrial fibrillation are treated. The TactiFlex Ablation Catheter SE brings the best of Abbott’s ablation technologies into a single catheter.”
Last month, the FDA approved the company’s Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices.