Sam Brusco, Associate Editor11.20.23
Medtronic has obtained CE mark approval for its PulseSelect pulsed field ablation (PFA) system and Nitron CryoConsole.
PulseSelect treats atrial fibrillation (AFib) using a novel ablation modality that uses pulsed electric fields to isolate the pulmonary veins. Medtronic said following EU approval of its Affter mapping and ablation system makes it the only company holding both single-shot and focal PFA options.
The company’s Nitron console build on the legacy of its Cryo franchise, as well.
The Nitron CryoConsole.
“With multiple CE mark milestones, today’s announcement demonstrates our commitment to innovation and building a strong electrophysiology portfolio,” Rebecca Seidel, president of Medtronic’s Cardiac Ablation Solutions business, told the press. “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.”
PulseSelect’s non-thermal approach targets the pulmonary veins for ablation, which the company said avoids unwanted injury to surrounding structures. The catheter’s biphasic waveform has an over-the-wire design and 20-degree tilt forward to support maneuverable, reliable, safe procedures, Medtronic also said.
Based on data from the PULSED AF trial, the catheter has demonstrated efficient pulmonary vein isolation with an average of 30 seconds of total energy delivery time to isolate all veins. The next-gen Nitron console supports Nitron console supports the company’s commercially available Arctic Front and Freezor family of cardiac cryoablation catheters.
“In addition to the state-of-the-art Sphere-9 Catheter with the Affera Mapping and Ablation System, we are thrilled to see the continuous innovation of our legacy Cryoablation with Nitron alongside the approval of single-shot PulseSelect PFA system,” said Khaldoun Tarakji, MD MPH, chief medical officer of Medtronic’s cardiac ablation solutions business. “Every patient deserves the best care. What motivates all of us at Medtronic is the privilege of serving patients by empowering electrophysiologists globally with the safest and most effective ablation technologies that seamlessly integrate with their workflows and enable them to tailor therapy based on their patients’ needs.”
PulseSelect treats atrial fibrillation (AFib) using a novel ablation modality that uses pulsed electric fields to isolate the pulmonary veins. Medtronic said following EU approval of its Affter mapping and ablation system makes it the only company holding both single-shot and focal PFA options.
The company’s Nitron console build on the legacy of its Cryo franchise, as well.
The Nitron CryoConsole.
PulseSelect’s non-thermal approach targets the pulmonary veins for ablation, which the company said avoids unwanted injury to surrounding structures. The catheter’s biphasic waveform has an over-the-wire design and 20-degree tilt forward to support maneuverable, reliable, safe procedures, Medtronic also said.
Based on data from the PULSED AF trial, the catheter has demonstrated efficient pulmonary vein isolation with an average of 30 seconds of total energy delivery time to isolate all veins. The next-gen Nitron console supports Nitron console supports the company’s commercially available Arctic Front and Freezor family of cardiac cryoablation catheters.
“In addition to the state-of-the-art Sphere-9 Catheter with the Affera Mapping and Ablation System, we are thrilled to see the continuous innovation of our legacy Cryoablation with Nitron alongside the approval of single-shot PulseSelect PFA system,” said Khaldoun Tarakji, MD MPH, chief medical officer of Medtronic’s cardiac ablation solutions business. “Every patient deserves the best care. What motivates all of us at Medtronic is the privilege of serving patients by empowering electrophysiologists globally with the safest and most effective ablation technologies that seamlessly integrate with their workflows and enable them to tailor therapy based on their patients’ needs.”
