Abbott Initiates Enrollment in Global TactiFlex PAF IDE Study

August 4, 2020—Abbott announced the first enrollments in an investigational device exemption (IDE) study of the performance of the company’s investigational TactiFlex ablation catheter, sensor enabled (SE). The device is used for treatment of patients with paroxysmal atrial fibrillation (PAF).

The global, multicenter TactiFlex PAF IDE study will enroll 355 patients whose AF symptoms are unable to be managed by medication. In the study, patients will undergo an ablation procedure using the TactiFlex ablation catheter, SE. The study data will be submitted to support global regulatory approvals.

“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,” commented Professor Prash Sanders, MD, in the company’s press release. Prof. Sanders is Director of Centre for Heart Rhythm Disorders at The Royal Adelaide Hospital in Adelaide, Australia.