J&J secures European afib approval for Varipulse pulsed field ablation system

Johnson & Johnson MedTech’s Biosense Webster division has tallied up another regulatory clearance for its pulsed field ablation system, with a CE mark opening up access to Europe.

The Varipulse platform, which comes bundled with the company’s Carto 3 heart mapping system, received a green light for the treatment of intermittent atrial fibrillation that hasn’t responded to drug therapies. The continental go-ahead follows an approval in Japan this past January.

Pulsed field ablation uses short bursts of electric energy that disrupts certain cells more than others, without generating excess levels of heat seen in previous ablation approaches that can damage surrounding tissues and cause major complications.

“We believe pulsed field ablation has the potential to offer safer, more consistent and efficient workflows,” with Varipulse and Carto offering 3D visualizations of the procedure in real time, Biosense Webster President Jasmina Brooks said in a statement.

Earlier this month, the company presented results of a late-breaking trial at the International AF Symposium in Boston, comprising a single-arm study of 186 participants. In the year following a Varipulse procedure, more than three-quarters of treated patients saw their atrial fibrillation eliminated with no major side effects.

That number increased to 80% when isolating the participants who received “optimal” treatment, according to Biosense Webster. Additionally, the use of the Carto 3 mapping system was able to cut down the amount of X-ray imaging during the procedure to less than eight minutes.

J&J MedTech hopes to bring the system to the U.S., where it will compete with recently approved pulsed field ablation systems from Medtronic and Boston Scientific. Medtronic’s PulseSelect system claimed its own CE mark late last year while Boston Scientific’s Farapulse has enjoyed European approval since early 2021, just months before it bought the system and its eponymous developer in a $295 million deal.

At the same time, Abbott is looking to join the party with its Volt system, combined with its EnSite X cardiac mapping suite. The company said in January it had begun its first human procedures in Australia and plans to study the device across the Asia-Pacific region and Europe as it eyes a CE mark approval. Abbott also said it expects to receive a green light to launch a U.S. clinical trial in the first half of this year.

J&J estimates that afib affects more than 11 million people in Europe, making it the most common type of arrhythmia. If untreated, patients can face a five-fold increase in their risk of stroke. The company said that it expects the prevalence of the condition to increase by as much as 70% by the end of this decade.

In another approach to cut down afib-related stroke risks, Biosense Webster also said this week that it had begun enrolling patients in a pivotal U.S. study of its left atrial appendage elimination system, with the permanent heart implant that it acquired late last year from its buyout of Laminar.

J&J paid $400 million upfront for the company, which has developed a thin nitinol device that unfolds into a small ball and is inserted into a small pocket in the heart wall—an unnecessary pouch where, in patients with an irregular heartbeat, blood is more likely to pool and form dangerous clots that can travel to the rest of the body. Once in place, Laminar’s device is twisted in a circle to gather up the tissue and hold it shut. 

“Building on positive evidence from the early feasibility study, we believe the Laminar LAAX System has the potential to transform patient care by offering a viable alternative to long-term blood thinners,” said Jennifer Currin, J&J MedTech’s vice president of scientific affairs for cardiovascular and specialty solutions. 

“We look forward to learning more about how this innovative approach to LAA closure performs compared to currently available solutions,” added Currin, referring to devices from Abbott, Boston Scientific and Medtronic, which also entered the sector last year with its purchase of the Penditure clip-based implant.