JPM24: J&J’s Biosense Webster claims pulsed field ablation approval in Japan

Johnson & Johnson’s Biosense Webster division has claimed the first approval for its pulsed field ablation catheter with a regulatory green light in Japan.

The Varipulse platform for treating intermittent cases of drug-resistant atrial fibrillation—the irregular heartbeat associated with an increased risk of stroke—comes integrated with the company’s Carto 3D cardiac mapping system. It marks the first and only pulsed-field system approved in the country.

That puts Biosense Webster on track to compete in the nascent market with Medtronic, which snagged the FDA’s blessing for its PulseSelect system in December, as well as Boston Scientific, which aims to obtain a U.S. approval for its Farapulse catheter in the first quarter this year.

Pulsed field ablation uses short bursts of electric energy tuned to disrupt certain cells more than others, without generating excess heat. It aims to avoid some of the major complications that can come with traditional thermal ablation, which can damage tissues near the heart, such as nerves, blood vessels or the esophagus. 

Varipulse catheter
The multi-electrode Varipulse catheter. (Johnson & Johnson)

Varipulse includes a variable-loop, multi-electrode catheter, while the Carto system provides real-time visualization and physician feedback during ablation.

Previously released early results from a completed clinical trial in Europe showed that nearly 79% of patients had no afib symptoms for one year after the Varipulse treatment. The study also reported no primary side effects, the company said, adding that procedures could be completed in about an hour, with less than 10 minutes of X-ray fluoroscopy.

According to J&J and Biosense Webster, afib affects nearly 38 million worldwide and about 1.3 million people in Japan alone, making it the most common type of arrhythmia. Varipulse is currently under CE mark review in the European Union. The company is also developing the dual-energy Thermocool Smarttouch catheter, capable of toggling between pulsed field and traditional radiofrequency ablation.

During the J.P. Morgan Healthcare Conference in San Francisco this week, CEO Joaquin Duato talked about the recent growth of J&J’s medtech divisions and his goal of making that side of the company into a best-in-class technology business.

“In 2018, 20% of our sales were in markets that were growing more than 5%,” Duato said during J&J’s investor presentation on Jan. 8. “In 2023, we have 50% of our sales in markets that are growing more than 5%.”

“The value of our pipeline compared to 2018 has more than doubled. And we estimate that by 2027, one-third of our sales will come from new products,” he added.