The Nashua, N.H.-based company’s Xoft Axxent balloon applicators are part of its Xoft Axxent electronic brachytherapy system designed to perform intraoperative radiation therapy in early-stage breast cancer patients who meet specific selection criteria.
The balloon applicator is used to deliver a single dose of radiation to the lumpectomy cavity to target cancer cells directly and limit exposure to health surrounding tissue, iCad said.
“The Xoft Axxent balloon applicators offer an attractive option for physicians and patients who desire improved flexibility, precision and personalization in the targeted treatment of early-stage breast cancer. We are pleased to continue working with iCAD in offering our customers access to the most advanced cancer treatments, including the complete portfolio of Xoft System products, in the years ahead,” iCad Chinese distributor Chindex Medical Limited COO Liu Yu said in a prepared statement.
With the clearance, iCad said that its complete suite of Xoft System products are cleared and available in China.
“A growing number of countries recognize the unique benefits the Xoft System offers to both patients and clinicians in treating a range of cancers. In 2015, more than 268,000 women in China were diagnosed with breast cancer, more than 69,000 women died of the disease, and the incidence has been rising rapidly in recent years. Regulatory approval of Xoft Axxent balloon applicators in China represents a significant milestone in our continued efforts to bring this innovative, safe and clinically-proven treatment option to women worldwide with early-stage breast cancer,” CEO Ken Ferry said in a press release.