The ProSense® Cryoablation System could be a game changer for women over 70 with early-stage, low-risk breast cancer.
For decades, breast cancer treatment has often meant surgery, which can be an emotionally and physically taxing process that leaves lasting scars. A newly approved medical device is offering women another option that doesn’t involve going under the knife to remove breast tissue.
The U.S. Food and Drug Administration (FDA) has granted marketing authorization for ProSense®, a minimally invasive cryoablation treatment developed by IceCure Medical Ltd. The system uses extreme cold (-170C°) to destroy early-stage, low-risk breast tumors in women age 70 and above.
Here’s how it works: during the 30–45 minute outpatient procedure, doctors use ultrasound imaging to guide a thin, hollow cryoprobe (a thin, tube-like instrument) into the breast tumor. Once in place, the device releases liquid nitrogen, reaching temperatures as low as –170°C to form an ice ball that destroys the tumor cells. The frozen tissue is later reabsorbed naturally by the body.
“We are excited to add a minimally invasive choice around breast cancer treatments and to offer patients an effective, outpatient procedure,” said Eyal Shamir, chief executive officer of IceCure. “With the ProSense® Cryoablation System, we are giving women with low-risk, early-stage breast cancer the choice to freeze their cancer, not their lives, through an effective treatment that minimizes recovery time, and minimal cosmetic changes to the breast.”
This is the first and only medical device to receive FDA marketing authorization for the local treatment of breast cancer, which is a milestone that could transform how doctors approach early-stage cases.
Some of the major benefits of this treatment option include the ability to maintain breast shape, reduced recovery time, and a short procedure time. Your breasts may also stay intact in ways that may not be possible with more invasive procedures.
“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,” said breast cancer patient and ICE3 trial participant, Pam Dixon, when describing her experience with the ProSense® cryoablation procedure. “There was no pain. It was one of the easiest things I’ve ever done. I don’t remember any limitations on my activity.”
For women navigating breast cancer treatment decisions, especially those seeking less invasive options, ProSense® could prove to be a viable alternative.