Abbott announces new late-breaking data from four trials on PFA, CSP portfolios

Abbott (ABT) announced new late-breaking data from four trials that demonstrate “strong” clinical outcomes within its pulsed field ablation, PFA, and conduction system pacing, CSP, portfolios to treat heart rhythm disorders. New six-month data from the FlexPulse IDE study provide early insights showing “positive” patient outcomes with Abbott’s TactiFlex Duo Ablation Catheter, Sensor Enabled, and confirms the strong safety and efficacy profile seen in the CE Mark study for treating complex AFib cases. The data for the 188-patient FlexPulse IDE study show: The majority of patients reported being free from documented arrhythmias. A high safety profile with no major safety events. The majority of patients were treated exclusively with PFA, demonstrating that this energy source alone was successful in treating complex cases. Physicians efficiently treated their patients – 93.9% did not require an additional ablation after the first round of therapy. Results from two late-breaking clinical trials evaluated Abbott’s investigational leadless and traditional pacing/defibrillation CSP technologies designed to deliver left bundle branch pacing, an approach intended to more closely replicate the heart’s natural electrical activation. Key findings included: A high safety profile with no lead-related major safety events reported. A high success rate meeting left bundle branch area pacing criteria which can be compared to results from previously reported trial. An 86% success rate was met using the more stringent LBBP or likely LBBP criteria. An average of fewer than one repositioning attempt per patient was also achieved. 100% defibrillation success, with the majority achieving first shock success at 20J. No patients required repositioning of the ICD lead to achieve effective defibrillation.