Cryoablation for Breast Cancer
What is Cryoablation for Breast Cancer?
At IceCure, we believe that women facing a breast cancer diagnosis should be empowered to find the treatment option that is right for them.
As the first and only FDA-cleared medical device for the local treatment of low risk breast cancer, our ProSense® System is giving women the power of choice with minimally invasive cryoablation. Now you can freeze your cancer, not your life.
Cryoablation for Breast Cancer
What is Cryoablation for Breast Cancer
At IceCure, we believe that women facing a breast cancer diagnosis should be empowered to find the treatment option that is right for them.
As the first and only FDA-cleared medical device for the local treatment of low risk breast cancer, our ProSense® System is giving women the power of choice with minimally invasive cryoablation. Now you can freeze your cancer, not your life.
The Breast Cancer Cryoablation Procedure
Breast cancer cryoablation uses ultra-cold temperatures to freeze and destroy breast tumors by creating an ice ball around the targeted tissue. To achieve such extreme temperatures, ProSense® utilizes liquid nitrogen to reach temperatures lower than –170° C.
After local anesthesia is administered, a small nick is made to the skin using a scalpel, and a thin, needle-like cryoprobe is inserted into the targeted tissue under ultrasound guidance.
Ultra-cold liquid nitrogen flows to the cryoprobe in a closed loop system, and an ice ball begins to form encompassing the tumor. A freeze-thaw-freeze cycle is performed to ensure maximum tumor destruction, including a rim of healthy tissue.
After the last freeze, an active thaw step allows the cryoprobe to be extracted, and a steri-strip or band-aid is placed over the small incision. Over time, the necrotic debris of the tissue that has been destroyed is naturally reabsorbed by the body over time, and adjacent tissue is left unharmed.
Performed in a doctor’s office under 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.
Who is breast cancer cryoablation 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 adjuvant endocrine therapy (also known as hormone therapy).
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.
*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 clinical negative lymph node (N0).
How Effective is Breast Cancer Cryoablation?
IceCure conducted the ICE3 Study – the largest multi-center clinical trial completed for liquid-nitrogen (LN2) – based cryoablation for patients with low-risk, early-stage breast cancer without surgically removing the breast tumor.
Safe &
Effective
5 year-results for the ICE3 clinical study provided evidence to assess the safety and efficacy for the ProSense cryotherapy treatment of low-risk, early-stage breast cancer with endocrine therapy.
3.1%
Rate of Local Recurrence
Patients treated with cryoablation
and endocrine therapy**
99.1%
Patients
97%
Physicians
Very satisfied or satisfied
with cosmetic outcome***
Many clinical studies on breast cancer cryoablation have been conducted and new one’s are currently ongoing.
Read our blog to learn more about the clinical evidence to date and ongoing studies.
**ICE3 Clinical Trial: 3.1% of patients treated with cryoablation and endocrine therapy are estimated to experience local recurrence of breast cancer within 5 years after treatment based on study results.
***99.1 % of patients and 97% of physicians responding to a survey stated they were ‘satisfied’ or ‘very satisfied’ with the breast cosmetic outcomes at 5 years follow up.
How Does Cryoablation Compare to Other Treatment Options?
Cryoablation with ProSense® freezes and destroys the breast tumor in place, without surgically removing breast tissue. The procedure is performed under ultrasound guidance, typically with local anesthesia. ProSense® is FDA-cleared for women aged 70 and older with biologically low-risk breast tumors that are 1.5 cm or smaller and treated with adjuvant endocrine therapy.
Lumpectomy, or breast-conserving surgery, removes the tumor and a rim of healthy tissue and is often followed by radiation or other adjuvant therapies. Unlike lumpectomy, cryoablation does not require surgical excision, general anesthesia, sutures, or a larger incision in appropriately selected patients.
Lumpectomy removes tissue and a rim of healthy tissue, which is also available for pathology review, while cryoablation destroys the tumor as well as an area of healthy tissue in place and requires follow-up imaging. Treatment choice depends on tumor biology, size, imaging visibility, lymph node status, and physician recommendation.
Other minimally invasive approaches include Radiofrequency Ablation (RFA) and Microwave Ablation (MWA), which use heat to destroy tissue. These technologies have FDA-cleared devices for soft tissue ablation or surgical adjunct use, but they do not have the same FDA-authorized indication as ProSense® for local treatment of low-risk breast cancer in the United States.
In summary, in the US, lumpectomy remains a standard surgical option, while ProSense® cryoablation offers an FDA-authorized, minimally invasive option for a specific group of women aged 70 and older with low-risk breast cancer receiving endocrine therapy. RFA and MWA, have FDA-cleared uses, but not the same breast cancer treatment indication.
The Benefits of Minimally Invasive Cryoablation for Low-Risk Breast Cancer
Maintain breast shape
with minimal scarring
As no tissue is removed during the procedure, patients and doctors alike reported they were very satisfied or satisfied with the cosmetic results****
Freeze your cancer,
not your life
Short outpatient procedure with minimal pain and discomfort; recovery to normal activity within median 1 day recovery time (range 0-8 days)*****
Performed under
local anesthesia
Numbing agents are injected only into the area being treated and the cold created by the ice formed also has a numbing effect
****99.1 % of patients and 97% of physicians responding to a survey stated they were ‘satisfied’ or ‘very satisfied’ with the breast cosmetic outcomes at 5 years follow up. ***** Based on ICE3 results.
ProSense® is cleared for breast cancer cryoablation in select markets; please contact us for a list of approved indications in your region.
What Can Happen After
Cryoablation for Breast Cancer?
Patients who have undergone cryoablation for breast tumors may experience:
- Mild-to-moderate pain following the procedure
- Edema (swelling)
- Bleeding
- Bruising
- Minimal scarring
- Damage to nearby tissue (skin burns)
- Tenderness
- Hematoma (bleeding into tissues).
Patients will also have a palpable (an area that can be felt) while your body naturally absorbs the cells that have been destroyed by the freezing process. Typically, the size of the mass reduces over time, depending on the initial size of the mass and other factors. In some cases, the mass may not completely resolve.
Following cryoablation for breast cancer, endocrine therapy (hormonal therapy) and periodic breast imaging will be included in your treatment plan with ProSense. Your doctor will discuss with you why endocrine therapy is necessary and how it should be taken. Follow-up breast imaging is important to monitor for any evidence of tumor recurrence.
Breast cancer treatment risks with cryoablation include tumor recurrence, incomplete ablation, theoretical risk of tumor seeding, death due to breast cancer. For a more detailed explanation of the benefits & risks of breast cancer cryoablation, read our
patient leaflet.
ProSense® is cleared for breast cancer cryoablation in select markets; please contact us for a list of approved indications in your region.
Frequently Asked Questions
What is cryoablation for breast cancer?
Cryoablation for breast cancer is a minimally invasive procedure that destroys targeted breast tumor tissue by freezing it. During the procedure, a thin cryoprobe is placed into the tumor under ultrasound guidance, and liquid nitrogen rapidly cools the surrounding tissue creating an ice ball that encompasses the cancerous tissue and extends beyond the tumor margin. The frozen tumor tissue is destroyed and is gradually reabsorbed by the body over time.
Is cryoablation for treating breast cancer FDA approved?
The ProSense® Cryoablation System has FDA marketing authorization for the local treatment of breast cancer in women aged 70 and older with biologically low-risk tumors that are 1.5 cm or smaller, when treated with adjuvant endocrine therapy. The FDA-cleared indication applies to a defined patient population, so eligibility should be discussed with a physician.
Why is endocrine therapy included with breast cancer cryoablation?
Cryoablation provides local tumor treatment by freezing and destroying the breast tumor, while endocrine therapy, also called hormone therapy, helps reduce hormone-driven cancer growth and may lower the risk of recurrence. ProSense® cryoablation is FDA-cleared for certain hormone receptor-positive, low-risk breast cancers and for patients that agree to adjuvant endocrine therapy.
How long will it take me to recover from cryoablation for breast cancer?
Recovery after breast cancer cryoablation is typically quick because the procedure is minimally invasive, performed through a small skin incision, and usually done with local anesthesia. Based on ICE3 clinical study results, patients treated with ProSense® cryoablation returned to normal activity in a median of 1 day, with a reported range of 0 to 8 days.
Will my insurance cover cryoablation for breast cancer?
nsurance coverage for breast cancer cryoablation varies by insurance plan, medical policy, diagnosis, treatment setting, and physician documentation. In the U.S., breast cancer cryoablation can be reported with CPT code 0581T, a Category III code for percutaneous cryotherapy ablation of malignant breast tumor(s), including imaging guidance when performed.
CPT codes help describe procedures for billing, but they do not guarantee insurance coverage or payment. Patients should contact their insurance provider and treating physician to confirm coverage, prior authorization requirements, medical necessity documentation, and out-of-pocket costs for ProSense® cryoablation.
Where can I get cryoablation for breast cancer?
Breast cancer cryoablation with ProSense® may be available through physicians and medical centers in select markets where the system is cleared or authorized for use. Availability and approved indications vary by region. Patients should speak with their treating physician or contact IceCure to find out whether cryoablation is available and appropriate for their diagnosis.