FDA Grants Clearance to IceCure's Next-Gen XSense™ Cryoablation System with CryoProbes

Tuesday, July 02, 2024

IceCure Medical, a company specializing in minimally-invasive cryoablation technology, announced that it has received marketing authorization from the U.S. Food and Drug Administration (FDA) for its latest single probe cryoablation system, the XSense™ Cryoablation System with CryoProbes.

"This recent FDA clearance underscores the safety and effectiveness of our cryoablation platform."

"The XSense™ system is approved for the same uses as our ProSense® system, and we believe it has the potential to address additional significant medical needs in the U.S.

IceCure is at the forefront of liquid nitrogen-based cryoablation systems, offering a new minimally invasive treatment that benefits patients, healthcare providers, and payors."

The XSense™ system and its cryoprobes are approved for various applications, including general surgery, dermatology, neurology (such as cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology.

It is designed to destroy tissue by applying extreme cold, making it effective for treating fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions, and warts.

IceCure's technology, including the ProSense® and XSense™ Cryoablation Systems with CryoProbes, offers a minimally invasive method for destroying tumors by freezing them.

Using liquid nitrogen, the systems create extensive lethal zones to effectively destroy both benign and cancerous lesions in areas such as the breast, kidney, lung, and liver.

IceCure's cryoablation systems provide significant value by speeding up recovery, reducing pain, and minimizing surgical risks and complications.

Their portable design and use of liquid nitrogen allow for quick and convenient office-based procedures, particularly for treating breast tumors.






Source: prnewswire.com