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IceCure Unveils FDA Application for Innovative XSense™ Cryoablation System Integrated with Cryoprobes

Wednesday, April 03, 2024

IceCure Medical has filed a 510(k) submission with the FDA for its latest cryoablation system, the XSense™ System, and accompanying cryoprobes. This advanced technology is designed to offer a minimally invasive alternative for tumor destruction by freezing, building upon the success of IceCure's ProSense® System.

The submission seeks clearance for indications already approved for the ProSense® System, including minimally invasive cryoablation applications for kidney, liver, fibroadenomas, and neurology. Notably, the XSense™ System is being processed separately from IceCure's De Novo application for breast cancer indication, reflecting the company's commitment to expanding treatment options across various medical conditions.

IceCure's ProSense® Cryoablation System utilizes liquid nitrogen to create extensive lethal zones, effectively targeting benign and cancerous lesions in areas such as breast, kidney, lung, and liver. This innovative approach not only offers enhanced efficacy but also provides benefits such as quicker recovery times, reduced pain, and lower surgical risks and complications.

With its portable design and utilization of liquid nitrogen, the ProSense® System enables convenient office-based procedures for breast tumors, further enhancing patient care and treatment accessibility. As IceCure continues to advance cryoablation technology with the XSense™ System, it underscores the company's dedication to improving patient outcomes and expanding the scope of minimally invasive treatment options.