Medtronic’s Pulsed Field Ablation Earns Japanese Approval

Medtronic has won Japanese regulatory approval for its PulseSelect pulsed field ablation (PFA) system.
 
The latest regulatory nod follows U.S. Food and Drug Administration (FDA) approval late last year and CE mark clearance in November 2023. The Japanese Ministry of Health, Labour and Welfare (MHLW) approval was based on data from the pivotal PULSED AF IDE trial that evaluated PFA technology for atrial fibrillation (AF) ablation in a global study with centers in Japan.
 
Further, a new software upgrade became available for PulseSelect that features an automated delivery mode so physicians can control pulsed field applications during the ablation procedure. Medtronic said upgrades were made in new and existing systems in Europe and Canada and are beginning in the U.S. The upgrade will expand to Japan after approval.
 
“We are seeing tremendous excitement and adoption of PulseSelect in every market we have launched, including the U.S., Europe and Canada, said Rebecca Seidel, president of Medtronic’s Cardiac Ablation Solutions business. “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 RF and single-shot shot users who have adopted it. And now the expansion of PulseSelect into the important Japanese market is exciting for both physicians and for the patients they serve, who deserve the most advanced, safe, effective, and efficient care for AFib.”

More about PulseSelect pulsed field ablation (PFA)

PFA uses pulsed electric fields to treat AF by isolating the pulmonary veins. PFA’s mechanism of cell death is non-thermal, so there’s a potentially lower risk of collateral structure damage.
 
Medtronic’s PulseSelect PFA system, according to the company, has differentiated safety features and offers rapid, effective pulmonary vein isolation via consistent, predictable energy delivery and catheter maneuverability. The company also said, based on data on file, that the system was engineered so clinicians can have a seamless transition to PFA in their preferred workflow.
 
Since receiving the CE mark in Europe and first-ever PFA approval by the FDA, the company reported that cases have increased rapidly, with over 250 physicians globally successfully treating more than 3,000 patients with PulseSelect, together with the company’s bi-directional 10F FlexCath Contour sheath.