Cryoablation Update

FDA Panel Recommends to Approve of the De Novo Classification Request for the IceCure ProSense™ Cryoablation System

On November 7, 2024, the FDA General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee convened to discuss the clinical performance data gathered on the IceCure ProSense™ Cryoablation System. A vote on information relative to the benefits and risks profile for a De Novo Classification Request for the IceCure ProSense™ Cryoablation System for patients with early stage, low risk breast cancer for the treatment of breast cancer with adjuvant endocrine therapy took place.

The Ice3 Study demonstrated that the benefits of cryoablation outweigh risks for the treatment of breast cancer in patients ≥ 60, with prognostic Early Stage I, low risk (ER/PR +, Her2-) infiltrating ductal breast cancer, measuring <1.5 cm, and clinically lymph node negative¹.

After open public statements from the Sponsor, the FDA and consumers, and after deliberations and summation, the panel voted “yes” to the proposal “Considering the data from the Ice3 trial and reported outcomes in the literature for standard of care, do the benefits of the IceCure Medical, Ltd. ProSense™ Cryoablation System outweigh the risk from the proposed indication for use?” moving the De Novo Classification request for the IceCure ProSense™ Cryoablation System forward.

While the affirmative vote of the panel does not confer final approval of the De Novo Classification request, the panel’s clinical advisement is a critical aspect of the FDA process, deliberation and implementation of the classification and any associated special controls.

A full summary of the meeting proceedings will be posted to www.fda.gov within 48 hours.

The current ASBrS states on the subject of Indications for percutaneous and/or transcutaneous ablative treatments of malignant tumors of the breast: Cryoablation is currently approved for treatment of benign and malignant soft tissue tumors by the FDA. Currently, there are no specific technologies that have FDA approval for breast tumors. Participation in registries and clinical trials evaluating the use of these technologies with and without surgical excision of a breast malignancy is advised as early data emerges on their efficacy.

Based on the final decision of the FDA, ASBrS will review and assess the relevance and guidance in the 2018 Consensus Guideline on the Use of Transcutaneous and Percutaneous Ablation for the Treatment of Benign and Malignant Tumors of the Breast and revise as necessary.

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1. Fine RE, Gilmore RC, Tomkovich KR, et al. Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence. Ann Surg Oncol. Oct 2024;31(11):7273-7283. doi:10.1245/s10434-024-16181-0

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