August 04, 2020 – Abbott (Abbott Park, IL) announced first enrollments in the TactiFlex PAF IDE study to evaluate a new device to treat people suffering from paroxysmal atrial fibrillation (PAF), a type of irregular heartbeat.
The study will evaluate the performance of the investigational TactiFlex Ablation Catheter, Sensor Enabled (SE) for people whose atrial fibrillation (AFib) symptoms are unable to be managed by medication.
The TactiFlex PAF IDE study will enroll 355 patients who will receive an ablation procedure using Abbott’s TactiFlex Ablation Catheter, SE. Data collected from the study will be submitted to support global regulatory approvals.
Abbott says that the start of the TactiFlex PAF IDE trial is among a series of product-focused activities the company is currently engaged in.
The company also recently secured U.S. Food and Drug Administration (FDA) and CE Mark approval for the EnSite LiveView Dynamic Display. LiveView is designed to allow data from the Advisor HD Grid mapping catheter to be visualized in real time during cardiac ablation procedures. The Advisor HD Grid catheter is designed to capture information often missed with traditional mapping catheters.