FDA Brief: Cryoablation Technology Receives Breakthrough Device Designation in Breast Cancer
Posted: Tuesday, April 13, 2021
On April 5, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation for ProSense’s minimally invasive cryoablation technology and approved indication for treatment of patients with TI invasive breast cancer and those with breast cancer who are not eligible for surgical alternatives. The FDA designation is another approval for the cryoablation technology, which is already accepted for use in the management of kidney, liver, and benign breast tumors.
The FDA designation was based on favorable results stemming from multiple clinical trials, with updated interim results of the ICE3 trial to be presented at the upcoming American Society of Breast Surgeons Annual Meeting later this month. The cryoablation technology was shown to be safe and effective in removing cancerous tumors through freezing.