Treating Breast Tumors with Cryoablation

Choose Cryoablation with IceCure First

At IceCure, we believe in choice. The ProSense Cryoablation System expands choice by providing a minimally invasive option to freeze and destroy breast tumors without removing them (lumpectomy), allowing women to maintain the shape of their breast. ProSense uniquely enables a fast and convenient office-based procedure with minimal pain and fewer complications compared to surgical alternatives.

It’s Your Choice.

Treating Breast Tumors with Cryoablation

Choose cryoablation with IceCure first

At IceCure, we believe in choice. The ProSense Cryoablation System expands choice by providing a minimally invasive option to freeze and destroy breast tumors without removing them (lumpectomy), allowing women to maintain the shape of their breast. ProSense uniquely enables a fast and convenient office-based procedure with minimal pain and fewer complications compared to surgical alternatives.

It’s Your Choice.

Choose How to Treat your Breast Tumor

Fibroadenomas are the most common form of benign breast tumors, experienced by as many as 10% of women.

Traditional fibroadenoma treatment has involved excisional biopsy or lumpectomy to remove the fibroadenoma, requiring hospitalization, anesthesia, scarring and extended recovery time.

Cryotherapy offers a minimally invasive fibroadenoma treatment without surgery and optimal cosmetic outcomes. The ProSense™ system also enables the patient to undergo in-office cryoablation treatment that is effective, painless, and faster than other procedures.

75%

of patients had no breast tumor at 1 year follow-up1

96%

of patients and physicians rated cosmetic results as excellent or good1
1 Golatta, M., Harcos, A., Pavlista, D., Danes, J., Klein, R., Simovich, P., Gruber, I., & Hahn, M. (2015). Ultrasound-guided cryoablation of breast fibroadenoma: a pilot trial. Archives of Gynecology and Obstetrics, 291(6), 1355-1360. doi:10.1007/s00404-014-3553-5.

ICE3 Interim Results for Breast Cancer

IceCure is conducting the ICE3 study, which is the largest controlled multi-location clinical trial ever performed for cryoablation of small, low-risk breast cancer* with promising interim results.

96.91%

of patients were recurrence free2

100%

Safe procedure – no significant device-related adverse events or complications2

100%

of patients and doctors were satisfied with cosmetic results2
2 Based on Interim Analysis Performed in July 2022

Testimonials

“Cryoablation potentially represents a dramatic improvement in care for appropriate low-risk patients, and at three years post-treatment, the ICE3 trial results are extremely positive. The non-invasive procedure is fast, painless and can be delivered under local anesthesia in a doctor’s office. Recovery time is minimal and cosmetic outcomes are excellent with little loss of breast tissue and no scarring. Now, this trial is underscoring the efficacy and safety of the procedure for this patient group.”

Richard E. Fine, MD, FACS, Director of Education and Research and practicing breast surgeon at West Cancer Center’s Comprehensive Breast Center, TN and ICE3 Investigator

Breast Cryoablation: How Does it Work? 

Breast cryoablation uses ultra-cold temperatures to destroy the tumor by freezing. Performed in a doctor’s office under ultrasound guidance and only local anaesthesia, the entire procedure from start to finish generally takes an hour. Patients can return to their daily routine quickly and maintain the shape of their breast.

  • Under ultrasound guidance, a thin, needle-like cryoprobe is inserted into the targeted tissue
  • Ultra-cold liquid nitrogen goes 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 small steri-strip or band-aid is placed over the small incision. Over time the necrotic debris of the destroyed tumor is removed by the body through natural processes

Choose to Maintain Breast Shape

With an optimal experience and proven results, IceCure empowers treatment choice so patients can now get the care they need and maintain their breast shape:

Breast remains whole:

The size and the shape of the breast are maintained

Excellent patients & physician satisfaction:

100% satisfied with cosmetic results2
Recovery

Minimal to no scarring:

Small nick covered with a band-aid

*The ICE3 study is the largest controlled multi-location clinical trial ever performed for cryoablation of small, low-risk breast cancer. The FDA has not yet granted ProSense clearance for the treatment of breast cancer. Please refer to your country’s user manual for a list of approved indications in your region.

Choose a Better Treatment Experience

Opening the door for office-based treatment of breast tumors, IceCure’s ProSense provides a fast and convenient minimally invasive procedure:

  • Single cryoprobe, liquid nitrogen system: Tumor can be treated at a single-entry point with ultra cold temperature for optimal ablation
  • Fast office-based procedure: Takes about an hour with no hospital waiting or overnight stay
  • Rapid recovery: Get back to daily activities immediately, no need for follow-up reconstructive surgery
  • Minimal pain and discomfort: Local anesthesia together with cooling from the cryoablation itself reduces pain
  • Local anesthesia: Eliminates risks from general anesthesia required during surgery
  • Can be combined with other therapies such as chemotherapy, radiation, hormone therapy or immunotherapy 
  • Repeatable procedure: Can be performed multiple times if needed
  • Easy to use and efficient: Portable with small footprint, minimal set-up time, intuitive touchscreen

Resources

Case studies

Case Study: Embolization & Percutaneous Cryoablation to Treat Vertebral Metastasis for Pain Palliation

Treatment of a 34mm renal mass with a single cryoprobe cryoablation system using a relocation technique.

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Webinars

Webinar: Cryoablation in the Thoracic Cavity

This webinar lead by Dr. Julien Frandon of the Department of Radiology at CHU de Nîmes discusses various cases performed with the ProSense™ Liquid Nitrogen (LN2) Based Cryoablation System in the thoracic cavity (i.e. lung, mediastinum). (60 minutes)

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Publications

Feasibility and Safety of Single-Probe Cryoablation with Liquid Nitrogen: An Initial Experience in 24 Various Tumor Lesions

The aim of this retrospective study was to assess the feasibility of the IceCure’s single-probe liquid nitrogen system for tumor lesions of various sizes and locations, and to evaluate the safety of cryoablation with this technique.  

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