Key Takeaways:
Abbott (NYSE: ABT) bolstered its competitive stance in the cardiac rhythm management market, presenting late-breaking data from four trials that showed strong safety and efficacy across its ablation and pacing portfolios, including an 87% arrhythmia-free rate at six months for its TactiFlex Duo catheter.
"The data from these clinical trials serve as a cornerstone for the new innovations we’re developing to help people live healthier lives," said Priya Jagasia, divisional vice president of regulatory, clinical, reimbursement and strategic initiatives at Abbott, in a statement from the Heart Rhythm Society (HRS) 2026 meeting in Chicago.
The new data includes six-month results from the 188-patient FlexPulse IDE study, where the TactiFlex Duo catheter, which combines radiofrequency and pulsed field ablation (PFA), left 87% of patients free from documented arrhythmias. The trial reported a 98.3% safety profile with no major safety events. Abbott's Volt PFA system also demonstrated a high safety profile with no complications in a separate trial focused on posterior wall ablation.
The positive results strengthen Abbott’s position against rivals like Johnson & Johnson, Medtronic, and Boston Scientific in the multi-billion dollar electrophysiology market. The data supports the company's strategy of building a comprehensive portfolio, with the dual-energy TactiFlex Duo directly challenging similar technology from Johnson & Johnson and the Volt PFA system competing in the increasingly crowded PFA space.
The FlexPulse IDE study is designed to secure U.S. Food and Drug Administration approval for the TactiFlex Duo catheter, which already has a CE Mark in Europe. Data presented at HRS showed that 93.3% of patients were treated exclusively with the catheter's PFA energy source, and 93.9% of patients did not require an additional ablation procedure.
"The Abbott TactiFlex Duo catheter offers the convenience of seamlessly switching treatment between radiofrequency and pulsed field ablation based upon the patient's anatomy and their personalized ablation plan," said Dr. Jonathan Piccini, a professor of medicine at Duke University Medical Center who presented the data.
Meanwhile, six-month data from the Volt CE Mark Extension Cohort trial highlighted the system's efficiency, with physicians averaging just 4.1 applications per vein. The Volt system, which is already FDA and CE Mark approved, competes with PFA systems like Boston Scientific's Farapulse and Medtronic's PulseSelect.
Abbott also showcased promising initial results for two investigational conduction system pacing (CSP) devices designed to better replicate the heart's natural rhythm.
The ASCEND CSP IDE trial for the UltiSynq CSP ICD lead met its primary safety and effectiveness endpoints at three months. The trial reported a 97.5% safety profile and a 99% success rate in meeting left bundle branch area pacing criteria. The device also achieved 100% defibrillation success, with 92.5% of patients converting on the first shock.
In a first-in-human study of the AVEIR CSP leadless pacemaker, one-month data from 19 patients showed a high implantation success rate and reliable electrical performance. The results are an early but important step for Abbott in the leadless pacing segment, a market pioneered by Medtronic.
This article is for informational purposes only and does not constitute investment advice.
