Johnson & Johnson Medtech’s Biosense Webster division presented the final results from a yearlong study of its upcoming Varipulse pulsed field ablation system, showing that more than three-quarters of treated patients saw their atrial fibrillation eliminated with no major side effects.
Presented as a late-breaking trial at the International AF Symposium in Boston, the single-arm study followed 186 participants with an intermittent irregular heartbeat. Researchers found that in the 12 months after undergoing a pulsed field ablation procedure to isolate the heart’s pulmonary vein, 75.6% of patients showed no signs of afib recurrence as well as no evidence of other atrial arrhythmias, such as tachycardia or flutter.
According to Biosense Webster, that proportion increased to 80% when considering participants who received “optimal” pulsed field ablation applications. In addition, the company said that by combining the Varipulse system with its Carto 3 heart mapping system, the procedure was able to be completed with less than eight minutes of X-ray fluoroscopy.
Pulsed field ablation delivers short bursts of electric energy that disrupts some cells more than others to avoid some of the complications linked to thermal ablation such as unwanted tissue damage.
Varipulse received its first regulatory green light earlier this year with an approval in Japan, and the system is currently undergoing CE mark review in Europe.
The J&J company also presented two other studies at the symposium, including another Varipulse trial that evaluated 20 patients over the course of 12 months. In that trial’s pilot phase, 100% of treated participants were able to avoid subsequent ablations, and 80% had seen no signs or symptoms of afib by the one-year mark, while no device-related side effects were reported.
That study also reported 3.5 minutes of median fluoroscopy time, with the entire procedure clocking in around 90 minutes.
Separately, Biosense Webster presented real-world data backing up the company’s approach to a zero-fluoroscopy workflow to eliminate the need for radiation exposure to patients and providers in the cath lab. The company received the first FDA green light allowing its afib catheters to be used with ultrasound instead of X-ray guidance in August 2023.
“The results of this real-world evidence demonstrate that a zero fluoroscopy workflow can enhance patient care while also making procedures safer and more comfortable for medical staff by removing the need to wear heavy protective gear for hours each day,” Biosense Webster President Jasmina Brooks said in a statement.
The study collected registry data from 16 sites. Among 208 patients, three primary adverse events were reported, including one pseudoaneurysm, one hematoma and one case of pulmonary vein stenosis. Pulmonary vein ablation success rates were rated at 100%.
Afib is the most common type of abnormal heart rhythm, affecting more than 6 million people in the U.S. and nearly 38 million people worldwide, according to J&J.
The recent rise of pulsed field ablation has seen the launch of FDA-approved systems from Medtronic and Boston Scientific. Meanwhile, Abbott has begun its first human trials in the sector, and startups have attracted investments in developing their own approaches, such as Cortex and its $90 million funding round last December.