Johnson & Johnson’s Reports the CE Mark Approval for Dual Energy Thermocool Smarttouch SF Catheter for Cardiac Arrhythmias
Shots:
- The CE mark of Thermocool Smarttouch SF Catheter for cardiac arrhythmias was based on SmartfIRE trial in European patients with refractory PAF that depicted 100% acute success rate & first-pass isolation achievement in 96.8% of veins (published in Apr 2024). The Trupulse Generator hardware compatibility is anticipated in H1’25
- The company has concluded recruitment in SmartPulse (n=250; 27 sites in the US) & PulseSmart (n=136; 7 sites in Australia & Canada) studies assessing the device in patients with PAF for global availability
- The platform consists of an irrigated, contact-force sensing Thermocool Smarttouch SF Catheter & Trupulse Generator that enables electrophysiologists to toggle b/w the radiofrequency & pulsed field energies on the generator monitor
Ref: Johnson & Johnson | Image: Johnson & Johnson
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