A Medical Device Daily
North American Scientific (Chatsworth, California), a manufacturer of brachytherapy sources, reported that the company has received 510(k) clearance from the FDA to market the low-dose rate radiation treatment design of its breast brachytherapy product, designed to enhance current accelerated partial breast irradiation (APBI) treatment options. The multi-channel catheter system is designed to allow for either low-dose therapy, using the company's existing Prospera I-125 seeds, or high-dose rate treatments.
President and CEO L. Michael Cutrer called the approval “a key step toward executing on our Breast Brachytherapy strategy.“
The company said it expects to file a second 510(k) application with the FDA to market a similar device for the high-dose rate procedure. It said will launch both APBI devices in November at the annual meeting of the American Society of Therapeutic Radiology and Oncology (Fairfax, Virginia).
“While we may see the first patients utilizing our device as a low-dose rate treatment, we feel it is equally important that a high-dose rate option is also available to the market,“ Cutrer said.