A New Milestone for Breast Cancer Care: Cryoablation is Now FDA-Cleared for Low-Risk Patients 

For nearly two decades, the standard of surgical care for small, low-risk breast cancer has been lumpectomy. Now ProSense® cryoablation is the first-and-only medical device to be FDA approved for the treatment of low-risk breast cancer. ProSense® is poised to be a game changer to provide minimally invasive treatment for appropriately selected breast cancer patients. Women can now freeze their cancer with cryoablation, without surgery and maintain the shape of their breast.  

How does cryoablation for breast cancer work?  

For decades, cryoablation has proven effective for the ablation of benign and cancerous tumors in a variety of indications. Cryoablation for breast cancer is a minimally invasive procedure. Performed in an office-based, outpatient setting, cryoablation gives patients an extra level of comfort. Using local anesthesia and ultrasound guidance, a thin needle-like cryoprobe is inserted into the breast tumor.  

Liquid nitrogen with temperatures of -150°C or lower circulates through the cryoprobe in a close-looped system. A freeze-thaw-freeze cycle begins that is lethal to cancer cells. An ice ball forms around the tumor, destroying cancer cells. Ultrasound is used to monitor the ice ball growth over time. This ensures the tumor is completely engulfed, along with a margin of surrounding healthy tissue. Over time, the body rids itself of the destroyed tissue through the necrotic process. The entire procedure takes about 45 minutes from start to finish.  

The cold ice ball left inside the breast has a numbing effect, alleviating discomfort.  The procedure is not performed under general anesthesia, leaving patients awake during breast cancer cryoablation. Afterwards, many are often able to drive themselves home from the appointment. Recovery time on average is 24 hours return to normal activities.  No tissue is removed from the breast. Only a small incision is made to insert the cryoprobe. Patients and physicians alike report high rates of cosmetic satisfaction.  

What types of breast cancer patients does the FDA indication include? 

The recent FDA clearance extends the range of cancer cases that can benefit from cryoablation to include breast cancer patients ≥70 years of age with biologically low-risk tumors ≤1.5 cm in size, including patients not suitable for surgery. The clearance also stipulates that patients follow up treatment with endocrine therapy.  

Biologically low-risk breast cancer is defined as unifocal tumor, size ≤1.5cm, 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). 

ProSense® is pioneering breast cancer cryoablation  

IceCure’s ProSense Cryoablation System is the first and only system to be granted FDA authorization for the local treatment of low-risk breast cancer. The system is easily moveable with a small physical footprint. ProSense® fits a variety of clinical settings, including office-based environments with no additional infrastructure needed. Since ProSense® uses liquid nitrogen, no gas lines, no on-site technicians, and no special safety rooms are required for storage.  

The ProSense® system is already in use in 30 clinics across the US, including the recently added Shero Imaging and Infirmary Health. A long-term advocate of de-escalation of cancer care and breast cancer cryoablation, Past-President of the American Society of Breast Surgeons, Dr. Nathalie Johnson, explains, “Being able to have an early tumor treated the same day in an office or outpatient center with no need for pain medication and less breast deformity is a pivotal change for many breast cancer patients.”   

In granting marketing authorization, the FDA requested that IceCure conduct a post-market surveillance study. The aim is to produce additional data in this indication. The post-market study expects to include 400 patients at 30 sites. An established CPTIII reimbursement code may be used to support claims and reimbursement for the study’s procedures.  

The FDA’s marketing authorization sets a clear precedent. Any company seeking 510(k) clearance for a cryoablation system to treat breast cancer will be required to provide five years of follow-up clinical data. 

Will cryoablation become a new standard of breast cancer care? 

With an average procedure time of 30-45 mins, including cryoablation into care pathways reduces the need for hospital stays and the burden on surgical facilities.  Robert C. Ward, M.D., Associate Professor of Radiology at Brown University, who specializes in breast imaging and intervention, and has been using cryoablation for over 10 years. “A significant proportion of breast cancers that we diagnose nationwide would potentially benefit from this procedure instead of a lumpectomy,” said Dr. Ward. He estimates that approximately 150 patients who received lumpectomies at his hospital last year could have had ProSense cryoablation instead.   

Patients embrace cryoablation as ICE3 trials show high patient satisfaction 

Cryoablation offers an improved experience for breast cancer patients.  “Patients feel relaxed, some of them actually fall asleep during the procedure, and the ice has a numbing effect,” said Dr. Johnson.  Without any tissue removal, breast shape is maintained with cryoablation, which improves patient satisfaction.  

Results based on the ICE3 trial on breast cancer cryoablation found that 99.1% of patients and 97% of physicians were satisfied with cosmetic results 5 years following the procedure. A growing number of patients are seeking clinics that offer cryoablation, even paying out of pocket to receive the minimally invasive procedure. ICE3 patient, Pam Dixon, was enthusiastic about her experience; “You don’t need any kind of cosmetic follow-up, you don’t have a scar, and you don’t have the feeling of having lost part of your breast, because it’s all still there. There was no pain. It was one of the easiest things I’ve ever done.”*  

As part of the final 5-year follow-up data from the ICE3 trial was published in the Annals of Surgical Oncology, no significant adverse effects or complications were reported in the final analysis. Patient quality-of-life assessments showed a statistically significant improvement in distress at 6 months.  

ICE3 study lead author, Richard Fine, MD, FACS, of the West Cancer Center & Research  Institute in Germantown, TN and past President of the American Society of Breast Surgeons emphasizes that, “The ICE3 study has proven that cryoablation with ProSense® is a safe, minimally invasive ablative procedure with results similar to that of lumpectomy patients who took endocrine therapy and has the benefit of being an office-based, non-surgical treatment. Further data coming out of the post-market study should continue to support that cryoablation with ProSense® is a successful option in the de-escalation of breast cancer care in appropriately selected patients.” 

Now is the time to act 

With FDA marketing authorization now in place, ProSense® can be offered for the local treatment of low-risk breast cancer in appropriately selected patients. This is a groundbreaking opportunity for breast surgeons and breast radiologists to add an office– or outpatient-based, minimally invasive option to their care pathways for eligible patients.  

As awareness grows and more centers add breast cancer cryoablation, the programs that bring it into practice early will be positioned to shape expectations clinically, operationally, and in how patients experience local treatment. To explore how ProSense® could fit into your practice, contact the IceCure U.S. team to discuss training, workflow set-up, and next steps to bring cryoablation to your patients.