Xoft® Axxent® Electronic Brachytherapy (eBx®) System®
Intraoperative radiation therapy, or IORT, is an electronic form of targeted radiation treatment that can treat select early-stage breast cancer patients in just one day. The procedure allows breast surgeons to work together with radiation oncologists in the operating room to precisely deliver a single dose of radiation at the time of lumpectomy, while the patient is still under anesthesia.
Once the breast surgeon removes the tumor, a catheter-like device with a flexible balloon applicator at the tip is temporarily placed inside the lumpectomy cavity. Within the balloon applicator is the Xoft System’s proprietary miniaturized x-ray source, which is energized to deliver a full course of high-dose rate, low energy radiation directly to the tumor bed. This targeted dose of radiation kills possible remaining cancerous cells while sparing healthy tissue, such as the heart, lung, and ribs. After the radiation has been delivered, the balloon is deflated, removed, and the cavity is closed.
IORT with the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® can administer an entire course of radiation in as little as eight minutes. The Xoft System is FDA-cleared, CE marked, and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including early-stage breast cancer, non-melanoma skin cancer and gynecological cancers.
IORT offers many patient benefits, including the added convenience of just one treatment, reduced exposure to radiation, fewer side effects, and lower financial costs, as compared to traditional radiation treatment. In fact, a recent study found that IORT is estimated to save the U.S. healthcare system more than $630 million over the lifetime of patients diagnosed annually with early-stage breast cancer, while also saving patients more than $10,500 for radiation therapy.
For many early-stage breast cancer patients, IORT is a lifesaving treatment that can allow them to return to normal daily activities within days, rather than weeks. IORT is suitable for women with DCIS, or whose cancer is stage 1 or 2 that has not progressed to the lymph nodes.
A growing body of favorable clinical data supports the use of IORT in patients meeting specific selection criteria. For example, the TARGIT-A trial studied women who received IORT at the time of lumpectomy and results showed women had similar recurrence rates compared to traditional treatment, or external beam radiation therapy (EBRT): 2.1% for IORT versus 1.1% for EBRT.
IORT was initially developed in Europe and the Xoft System technology was FDA cleared for use in the U.S. in 2005. Since then, Xoft IORT has rapidly been growing in adoption in the U.S. as more long-term data emerges and as more doctors, hospitals and medical practices learn about the procedure and want to offer it to their patients. More than 50 leading healthcare facilities around the globe have adopted Xoft IORT, and have treated more than 3,000 breast patients.