Boston Scientific, Abbott and Medtronic all presented successful readouts of their cardiac devices during the Heart Rhythm Society’s (HRS) 2026 annual meeting.
Medtronic presented new, late-breaking data from an early feasibility study on its cardiac arrhythmia portfolio – specifically a device in the Affera family – which looked at its potential to prevent fast and dangerous ventricular heart rhythms in patients who have had a heart attack.
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In the trial (NCT06703489), 65.5% of patients fitted with the Affera mapping & ablation system and the Sphere-9 catheter were free from ventricular tachycardia (VT) recurrence at six months. Medtronic’s system acts by destroying diseased cardiac tissue to restore a patient’s heart rhythm, with the technology achieving this through both pulsed field (PF) and radiofrequency (RF) ablation methods.
These positive results come as US regulators grant Sphere-9 a breakthrough device designation for the treatment of VT – potentially expediting the catheter’s route to market.
If approved, the Sphere-9 catheter could bolster Medtronic’s presence in the cardiac ablation market, as the company also secured the US Food and Drug Administration (FDA) greenlight for its pulsed-field ablation (PFA) therapy, PulseSelect, in 2023 – making it the first medtech company to commercialise a technology of this sort in the US.
At the 2026 J.P. Morgan Healthcare Conference in San Francisco, Medtronic’s CEO, Geoff Martha, noted that the PFA market could offer the company a multi-billion dollar market opportunity in the future.
Boston Scientific eyes continued PFA leadership
Meanwhile, Boston Scientific is looking to maintain its leading position in the PFA market with its alternative map-and-ablate catheter, FARAFLEX PFA, which is currently being explored in the single-arm ELEVATE-PF feasibility trial (NCT06510556).
The study is exploring how durable FARAFLEX PFA’s impact on pulmonary vein isolation (PVI) – a common technique used to stop the transmission of irregular electrical impulses from the pulmonary veins to the left atrium – can be in patients with atrial fibrillation (AF).
At HRS 2026, Boston Scientific presented data from the trial, which revealed that 95.6% of patients treated with FARAFLEX PFA saw PVI durability at the two-month mark.
The technology has also been proven safe and tolerable in this patient population, with no reports of stroke, red blood cell destruction, narrowing of the pulmonary veins or the tightening of the coronary artery thus far.
This initial outcome marks another win for Boston’s PFA portfolio, which includes the FARAWAVE and FARAPULSE PFA catheters. Currently, the medtech player predicts that its PFA arsenal will see double-digit growth in 2026, driven by a boost in usage of its existing and new catheters.
Abbott seeks TactiFlex Duo US market entry
As market leaders Boston Scientific and Medtronic fight it out for the top spot in PFA, Abbott is also seeking glory in this field with its TactiFlex Duo Ablation Catheter, which the company is currently evaluating in the FlexPulse IDE study (NCT06676072).
The interventional study is looking at the safety and efficacy of this sensor-enabled, RF and PF ablation tool in treating complex AF, with Abbott debuting late-breaking, six-month data from FlexPulse IDE at HRS 2026.
In the trial, 87% of patients remained free of documented arrhythmias at the six-month mark, with 93.3% receiving exclusive treatment with PFA. Abbott also proved the device to be safe, with 98.3% of participants avoiding any major safety events.
Abbott specifically designed this study to secure a US approval for the TactiFlex duo system, which received an EU CE mark in January 2026.
According to GlobalData, the value of the global electrophysiology ablation catheter market – the umbrella under which PFA sits – is will grow to $17.6bn in 2035 from $6.1bn in 2025.
