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Medtronic pulsed-field ablation system wins CE mark

November 20, 2023 By Chris Newmarker

This is a Medtronic marketing image of the PulseSelect pulsed field ablation system.
The PulseSelect pulsed field ablation system [Image courtesy of Medtronic]
Medtronic said today that it’s received a CE mark for its PulseSelect pulsed field ablation system.

In addition, the medtech giant received European Union approval for its Nitron CryoConsole, which builds upon the legacy of the company’s cryo franchise with features to optimize the workflow for cryoballoon ablation.

The news of the regulatory wins in the EU comes about eight months after the medtech giant received a CE mark for its Affera mapping and ablation system, which offers both pulsed field and radiofrequency ablation.

Pulsed-field ablation is a non-thermal method for cardiac ablation that has the potential to positively disrupt the way atrial fibrillation (AFib) is treated. Companies including Medtronic, Boston Scientific, Johnson & Johnson’s Biosense Webster and more are competing to get PFA systems onto the market. Medtronic officials have predicted they’ll be one of the first companies to the U.S. market with a pulsed-field ablation catheter.

“With multiple CE Mark milestones, today’s announcement demonstrates our commitment to innovation and building a strong electrophysiology portfolio,” said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of Medtronic’s Cardiovascular portfolio.

“These milestones are part of our investment in the future of our cryoablation franchise with Nitron, as well as the future of pulsed-field ablation with PulseSelect, following our more than ten years of scientific research and development,” Seidel said in a news release.

Read more about PulseSelect and Nitron CryoConsole in Medtronic’s news release. 

Filed Under: Catheters, Product Development, Regulatory Tagged With: Medtroinc, pulsed-field ablation (PFA)

About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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