The FDA has granted the ProSense Cryoablation System marketing authorization for small, low-risk breast cancers in women at least 70 years of age who receive adjuvant endocrine therapy. 

The authorization positions ProSense as a noninvasive alternative to lumpectomy. 

FDA’s decision was based on the single-arm ICE3 trial from the system’s maker, IceCure Medical. The study reported a 5-year recurrence rate of 3.7% among 124 women, comparable to rates seen with lumpectomy in similar patients. 

To confirm long-term benefit, FDA is requiring a post-marketing study involving approximately 400 patients across 30 centers, according to an IceCure press release.

ProSense has been on the US market since 2007 and is one of several cryotherapy systems authorized for general use in oncology, neurology, dermatology, surgery, and other settings. 

However, the FDA’s new clearance makes ProSense the first system authorized to advertise a specific breast cancer indication.

Meanwhile, another cryoablation system from Varian is under investigation as an alternative to lumpectomy in the COOL-IT trial. 

In its press release, IceCure highlighted the advantages of cryotherapy over lumpectomy: less pain, avoidance of surgical risks, shorter recovery, minimal cosmetic changes, in-office treatment in 30-45 minutes, and lower cost.

A ProSense patient quoted in the release said: “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” and no limits on activity. 

The new marketing authorization applies to older patients with a single, clinically node-negative tumor 1.5 cm or smaller that is estrogen receptor-positive, PR-positive, HER2-negative, with a low Ki-67 (< 15%) or genomic test showing low recurrence risk. Treatment is limited to invasive ductal carcinomas without lobular features, lymphovascular invasion, or an extensive intraductal component.

IceCure estimates about 46,000 women would qualify in the US annually. 

The procedure is performed under local anesthesia. A thin hollow needle, the cryoprobe, is inserted under ultrasound guidance, and liquid nitrogen is delivered to the tumor to encase it in an ice ball, destroying it in situ. Ultrasound confirms complete ice encapsulation.

Side effects in the ICE3 trial were generally mild-to-moderate and included edema, bruising, hematoma, skin burns, and post-procedure pain: all resolved without permanent effect. 

ProSense is currently eligible for reimbursement under a CPT III code covering up to $3800 in facility fees; additional coverage is expected in the future based on post-marketing experience and medical group recommendations.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com