New data on heart devices, including updates on Johnson & Johnson’s Varipulse pulsed field ablation platform and Abbott’s Navitor transcatheter aortic valve implantation system, were among the medtech developments grabbing attention at the 2025 European Society of Cardiology Congress recently held in Madrid.
Here are three updates to know from the meeting:
J&J reports positive real-world Varipulse data
J&J said its Varipulse PFA platform demonstrated strong safety and effectiveness and procedural efficiency in a real-world analysis of 791 patients treated for the heart arrhythmia atrial fibrillation.
The VARIPURE post-market sub-study showed a 0.6% primary adverse event rate, with no strokes or other PFA-related complications, and a 99.7% acute pulmonary vein isolation rate. The prospective study was conducted at 20 European centers.
The outcomes should give electrophysiologists the confidence to adopt PFA widely and safely, study author Alexandre Almorad, director of the arrhythmia unit at Brussels University Hospital St Pierre and at the Brussels Heart Rhythm Management Center, said in a J&J statement.
J&J is working to catch up with Boston Scientific and Medtronic in the rapidly growing PFA market after a setback earlier this year. The company briefly halted the U.S. launch of Varipulse to assess four neurovascular events, but resumed cases after determining the device operates as intended and updating the instructions for its use.
J&J said Tuesday it will continue to gather real-world evidence on Varipulse.
PFA vs. RFA
A 289-patient study presented at the ESC Congress found PFA was not more effective than radiofrequency ablation in treating patients with drug-resistant, intermittent atrial fibrillation.
However, PFA was associated with an improved safety profile and a shorter procedure time, and efficacy was high with both techniques, the study concluded.
The primary endpoint of single-procedure success at 12 months was similar between the procedure types, at 77.2% in the PFA group and 77.6% in the RFA group. Procedure-related serious adverse events, including unplanned hospitalizations, occurred in five patients (3.4%) in the PFA group and 11 patients (7.6%) in the RFA group.
Physicians have been shifting to PFA from other ablation methods for perceived advantages, including faster procedure times and more selective tissue targeting.
“Other trials have compared PFA with thermal energy sources with inconclusive results. We conducted the BEAT-PAROX-AF trial to directly compare PFA with advanced RFA in patients with antiarrhythmic drug-resistant symptomatic paroxysmal AF,” said principal investigator Pierre Jaïs, from L’Institut de Rythmologie et Modélisation Cardiaque in Bordeaux, France.
The trial, which received funding from the institute, Boston Scientific and a European Union research program, was conducted at nine centers across Europe.
Jaïs receives research grant and lecture fees from Boston Scientific, J&J, Medtronic and Abbott.
Abbott’s Navitor valve can treat more people
Abbott’s Navitor transcatheter aortic valve implantation system received the CE mark to treat people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open heart surgery.
Navitor was previously approved in Europe to treat symptomatic patients at high or extreme risk for surgery. It is also approved for that group in the U.S.
The expanded indication in Europe is expected to significantly increase the number of patients who can get the device, the company said Friday.
Aortic stenosis narrows the valve’s opening, restricting blood flow. Abbott’s replacement device is delivered to the heart through a small incision in the leg.
The latest approval was based on favorable safety and effectiveness data from the VANTAGE trial presented at the 2025 ESC Congress and published in JACC: Cardiovascular Interventions. The study of 434 patients found no moderate or greater backflow of blood at 30 days, with just 13.6% experiencing mild paravalvular leak. In 12-month follow-up, the first 262 patients had a low rate (2.3%) of all-cause mortality or stroke, below the performance goal of 11.3%.
Abbott competes with Edwards Lifesciences and Medtronic in the transcatheter aortic valve replacement market.
