Medtronic nets approval in Japan for pulsed field ablation system

The emerging field of pulsed field ablation continues to pick up speed around the globe, with Medtronic collecting a regulatory approval in Japan for its PulseSelect system to treat the world’s most common irregular heart rhythm, atrial fibrillation.

PulseSelect claimed the FDA’s first green light for the technology in the U.S. last December and obtained a CE mark in Europe the month before that.

Pulsed field ablation aims to disrupt the specific cardiac cells that power an abnormal heartbeat while sparing others by using tuned bursts of electric fields instead of relying on the traditional thermal energy that can cause comparatively more indiscriminate tissue damage.

With a thumbs-up from Japan’s Ministry of Health, Labour and Welfare, Medtronic will now compete with Johnson & Johnson’s Biosense Webster division, which garnered a go-ahead for its Varipulse platform back in January

“We are seeing tremendous excitement and adoption of PulseSelect in every market we have launched, including the U.S., Europe and Canada,” Rebecca Seidel, president of Medtronic’s cardiac ablation business, said in a statement. “The positive feedback on safety profile, ease of handling, and its flexibility to be used with any mapping system has been consistent across many focal [radiofrequency] and single-shot shot users who have adopted it.” 

The company said PulseSelect has so far been used by more than 250 physicians to treat over 3,000 patients. 

At the same time, Medtronic put forward a software update for the system that includes an automated therapy delivery mode. That upgrade has been delivered in Western Europe and Canada and is currently rolling out to U.S. users following a supplementary FDA approval earlier this month, the company said. 

“During development, our team designed the system to enable future software enhancements in the field. We are happy to report the first software update that automates the delivery of pulsed field energy and enhances the efficiency of the procedure,” said Khaldoun Tarakji, M.D., vice president and chief medical officer of the company’s cardiac ablation business.