AtriCure has launched the cryoSPHERE+ cryoablation probe, a device designed to improve post-operative pain management.
The cryoSPHERE+ probe, which is part of the cryoICE platform, has secured 510(K) approval from the US Food and Drug Administration (FDA) for temporarily blocking pain by ablating peripheral nerves in adult patients and intercostal nerves in adolescent patients.
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This new probe features advanced insulation technology that reduces freeze times by 25% compared to the legacy cryoSPHERE device.
AtriCure said the cryoSPHERE+ probe is currently in an extended limited launch phase in the US. It plans for a full launch by the end of the second quarter.
The device builds upon the safety and efficacy established by the original cryoSPHERE probe, which has been used in over 60,000 procedures since its clearance in November 2018.
AtriCure president and CEO Michael Carrel said: “cryoSPHERE+ is a meaningful innovation that I believe will improve patient care, enhance outcomes, and enable physicians to perform procedures with greater ease and confidence.”
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By GlobalDataThe cryoSPHERE+ device’s new technology minimises thermal loss and focuses energy at the ball tip, enabling a faster time to therapeutic temperature.
Froedtert & the Medical College of Wisconsin cardiothoracic surgery specialist Dr Mario Gasparri said: “The Cryosphere+ includes new technology that reduces energy loss for reduced freeze times, and a more rigid shaft which is important for applying consistent pressure during the procedure.
“Being able to get procedures done more quickly, when making multiple ablations on a single patient, is a huge advantage.”
Last year, AtriCure announced the first patient treatment with its AtriClip LAA Exclusion System in the Left Atrial Appendage Exclusion for Stroke Prevention (LeAAPS) clinical study.
The patient was treated with the system at the Franciscan St Francis Heart Center in Indianapolis, Indiana.
