Medtronic has received CE mark approval for its pulsed field system and cryoablation console devices used to treat atrial fibrillation.
Medtronic stated the PulseSelect and Nitron console will be available in selected European countries in early 2024.
Medtronic’s PulseSelect is the company’s latest pulsed field system. It uses a non-thermal approach to target pulmonary veins for ablation. Medtronic said that current thermal energy ablation technologies can risk injury to surrounding structures.
Medtronic highlighted results from its PULSED AF clinical trial, which demonstrated the catheter isolated pulmonary veins with an average energy delivery time of 30 seconds.
The device is designed as a “plug-and-play” system – it can be used with any mapping system or just with fluoroscopy, according to Medtronic.
Medtronic’s Nitron console also received a CE mark. The device supports the Arctic Front and Freezor family of cardiac cryoablation catheters in Medtronic’s range.
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The electrophysiology ablation global market was worth $2.7bn in 2022, according to a market model by GlobalData. The market is predicted to grow to $4.2bn by 2033 – cryoablation catheters will constitute $738m as a segment.
Medtronic, which has a 17% global share in the electrophysiology ablation catheter market, received European approval for its Affera mapping and ablation system in March 2023.
Medtronic’s cardiac ablation solutions business president Rebecca Seidel said: “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.”
November has been a successful month for Medtronic in the cardiovascular field – this week, it received US Food and Drug Administration (FDA) clearance for its renal denervation system. It joined ReCor Medical as the only two companies with approved devices in the US for the highly anticipated therapy.