Overview
The U.S. Food and Drug Administration (FDA) has granted marketing authorization for the IceCure ProSense Cryoablation System for the local treatment of breast cancer in women aged 70 and older with biologically low-risk tumors that are 1.5 centimeters or smaller and who are also receiving adjuvant endocrine therapy. This authorization includes individuals who are not suitable candidates for surgery. 

ProSense is a cryoablation (tissue-freezing) device. It works by circulating liquid nitrogen through a probe inserted into the tumor, rapidly freezing and destroying the cancer cells. 

How is treatment administered?
Treatment with the IceCure ProSense Cryoblation System is administered as an image-guided, office-based procedure. A small probe is inserted directly into the breast tumor using ultrasound or other imaging systems. Liquid nitrogen flows through the probe, creating an ice ball that destroys the tumor tissue. The treatment involves a freeze-thaw cycle and is completed during a single session. The device should be used exactly as prescribed and operated by a trained healthcare provider.

Potential adverse events
According to the ProSense Cryoablation System User Manual, common adverse events include bleeding, edema (swelling), erythema (skin redness), local pain, hematoma (localized bleeding outside blood vessels), breast bruising, swelling, skin burns, headache, puncture of adjacent tissues, and vasovagal reactions (such as fainting). Someone undergoing this treatment may also experience thermal injury to the breast skin or pectoral muscle, as well as scarring or skin necrosis (tissue death) at the treatment site.

Rare but serious adverse events may include infection, pneumothorax (collapsed lung), sepsis (life-threatening body response to infection), tumor seeding (cancer cells spreading to new areas), nerve injury, incomplete treatment that could lead to cancer recurrence, and death. Cryoablation near breast implants is not recommended unless the practitioner confirms adequate distance from the implant.

For more information about this treatment, visit:

ProSense Cryoablation System User Manual — IceCure