Israeli cryotherapy solutions provider IceCure Medical has received the US Food and Drug Administration (FDA) authorisation for its XSense cryoablation system with CryoProbes.
XSense is the company’s new-generation single-probe cryoablation system, designed to destroy tissue through the application of extreme cold temperatures.
The US regulator approved the XSense system with CryoProbes for all the indications that the company’s ProSense has already been approved.
The indications include general minimally invasive cryoablation in general surgery, dermatology, neurology, thoracic surgery, ENT, gynaecology, oncology, proctology, and urology.
IceCure CEO Eyal Shamir said: “This latest FDA regulatory clearance further validates the safety and efficacy of our platform cryoablation technology.
“The next-generation XSense system is cleared for the same indications as our flagship ProSense system and we believe it has future potential to address other indications in the U.S. for significant indications with unmet needs.
“Through our innovation, IceCure is a global leader in liquid nitrogen-based cryoablation systems that offer a new minimally invasive treatment with benefits for patients, doctors and payors alike.”
IceCure is a developer of minimally-invasive cryoablation technology that destroys tumours by freezing as an alternative to surgical tumour removal.
Its platform technology, including the ProSense Cryoablation System, XSense Cryoablation System and CryoProbes, offer a minimally invasive treatment option to destroy tumours.
The devices harness the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumour destruction in benign and cancerous lesions.
IceCure said that its cryoablation systems enhance patient and provider value by advancing recovery, and reducing pain, surgical risks, and complications.
