Cryoablation for Breast Cancer:
What It Is and How It Works
Women diagnosed with early-stage breast cancer now have more choice. Now with FDA clearance, cryoablation is possible for the local treatment of breast cancer in women aged 70 and older with biologically low-risk tumors*, less than 1.5 cm in size and who adhere to endocrine therapy.
Cryoablation for Breast Cancer:
What It Is and How It Works
Women diagnosed with early-stage breast cancer now have more choice. Now with FDA clearance, cryoablation is possible for the local treatment of breast cancer in women aged 70 and older with biologically low-risk tumors*, less than 1.5 cm in size and who adhere to endocrine therapy.
What is cryoablation?
Using extremely low temperatures (lower than –170°C), cryoablation freezes and destroys breast tumors by creating an ice ball around the targeted tissue. Under ultrasound guidance, a small, needle-like cryoprobe is inserted into the tumor and using liquid nitrogen the tumor is frozen. The destroyed tissue is naturally reabsorbed by the body over time and adjacent tissue is left unharmed.
Unlike surgery, no tissue is removed. The breast remains whole, with minimal scarring.
How the ProSense® procedure works
Breast cryoablation uses ultra-cold temperatures to destroy the tumor by freezing. Performed in a doctor’s office under ultrasound guidance and only local anesthesia, the entire procedure from start to finish generally takes less than an hour. Patients can return to their normal routine quickly and maintain the shape of their breast.
Step by step:
- A local anaesthetic is administered and a small nick is made in the skin. A thin, needle-like cryoprobe is inserted into the targeted tissue under
ultrasound guidance. - Ultra-cold liquid nitrogen flows into the cryoprobe in a closed loop system and an ice ball begins to form around the tumor. A freeze-thaw-freeze cycle is performed to ensure maximum tumor destruction.
- After the last thaw step, the cryoprobe is extracted and a steri-strip or band-aid is placed over the small incision. Over time the necrotic debris of the frozen and destroyed tumor is removed by the body through natural processes.
No tissue removed – breast remains whole with minimal scarring
Short outpatient procedure with minimal pain and discomfort
Performed under local anesthesia only – no general anaesthesia required
In-office treatment – no hospital admission
Who is cryoablation for breast cancer suitable for?
ProSense® is FDA-cleared for the local treatment of breast cancer in women aged 70 and above with biologically low-risk tumors, less than 1.5 cm in size, and who agree to endocrine therapy (also known as hormone therapy).
Biologically low-risk breast cancer is defined as: unifocal tumor, size ≤1.5 cm, ER+, PR+, HER2−, Ki-67 <15% and/or genomic testing indicative of low-risk breast cancer, infiltrating ductal carcinoma (excluding lobular carcinoma, extensive intraductal component, or evidence of lymphovascular invasion), and clinically negative lymph node (N0).
Speaking to your doctor can help you understand if the type of breast cancer you have been diagnosed with makes you a candidate for cryoablation.
What patients say about their experience
“There’s no pain. I was apprehensive that morning but there was no reason to be. When we left there, there was no pain. I went home, we had a regular dinner and I’ve never looked back.”
— Pam Dixon, ICE3 Trial Participant, USA
Cryoablation vs Lumpectomy
For eligible patients, cryoablation offers an option to explore alongside conventional surgical approaches. The right treatment depends on your individual diagnosis – your doctor can help you decide.
| ProSense® Cryoablation |
Lumpectomy | |
|---|---|---|
| Procedure type | Minimally invasive, in-office | Surgical procedure, operating room |
| Anaesthesia | Local only | General |
| Tissue removed | None – breast remains whole | Yes – tissue surgically removed |
| Recovery | Return to daily activities immediately | Weeks |
| Scarring | Minimal | Surgical scar |
| Duration | Typically around an hour | Varies |
Cryoablation is not suitable for all patients. Please discuss your options with your treating physician.
FDA clearance and clinical evidence
ProSense® is the first and only FDA-cleared medical device for the local treatment of breast cancer, giving women the power of choice with minimally invasive cryoablation. FDA clearance was granted for use in women aged 70 and above with biologically low-risk, early-stage breast cancer in combination with endocrine therapy.
The clearance was supported by the ICE3 Study – the largest multi-centre clinical trial completed for liquid nitrogen-based cryoablation in patients with low-risk, early-stage breast cancer without surgically removing the breast tumor.
Five-year ICE3 trial results:
3.1%
rate of local recurrence in patients treated with cryoablation and endocrine therapy
99.1%
Patients
97%
Physicians
very satisfied or satisfied
with cosmetic outcome
1 day
return to normal activity within a median of 24 hours
Ongoing evidence continues to be gathered through the ChoICE post-market study.
Cryoablation for Breast Cancer: Cost, Insurance and Access
If you are considering cryoablation for breast cancer, understanding your insurance coverage and how to access a provider are important next steps.
Insurance and coverage
Coverage for cryoablation varies by insurer and plan. As an FDA-cleared procedure, cryoablation may be eligible for coverage under Medicare and some private insurance plans for qualifying patients. We recommend contacting your insurer directly to confirm.
Questions to ask your insurer:
- Is cryoablation for breast cancer covered under my plan?
- What would my out-of-pocket cost be?
- Does the procedure require prior authorisation?
- Which providers are in-network for this treatment?