FDA Grants De Novo Approval for Cryoablation Treatment of Breast Cancer

The Food and Drug Administration (FDA) has granted De Novo approval of the ProSense cryoablation system for the local treatment of low-risk, early-stage breast cancer in women > 70 years of age.

The De Novo indication enables the use of minimally invasive cryoablation with the ProSense system in combination with adjuvant endocrine therapy for women > 70 years of age with low-risk breast tumors < 1.5 cm, according to IceCure Medical, the manufacturer of the ProSense cryoablation system.

Estimating that this patient population may be comprised of 46,000 women annually in the United States, IceCure Medical said the De Novo approval includes treatment of women who cannot undergo surgery for breast cancer treatment.

In an ICE3 multicenter trial examining the use of the ProSense cryoablation system for low-risk, early-stage breast cancer, researchers found that 96.3 percent of participants had no local recurrence after being treated with a combination of ProSense cryoablation and hormone therapy.

"As proven in the ICE3 study, cryoablation with ProSense is a safe, minimally invasive ablative procedure with results similar to that of lumpectomy patients who took endocrine therapy, with the benefit of being an office-based, non-surgical treatment,” noted Richard Fine, M.D., FACS, an investigator on the ICE3 trial. “Further data coming out of the post-market study should continue to support and confirm that cryoablation with ProSense is a successful alternative to surgical excision in appropriately selected patients."