New breast cancer therapy to be studied
Jul 20, 2011
Novian Health recently earned an investigational device exemption from the U.S. Food and Drug Administration (FDA), allowing the company to start studying its Novilase Interstitial Laser Therapy (ILT) System. The company previously developed Novilase Breast Therapy.
Novian's new therapy program is designed to remove malignant breast tumors up to 20 millimeters wide. The tumors would be removed by controlled heating, a minimally-invasive option for women who might otherwise opt for a lumpectomy.
The study, making breast cancer breakthroughs news, will consist of treating patients with Novilase ILT and the removal of cancerous tissue at least 28 days later. Images will also be taken of the tissue before it is removed. Data will be collected by researchers regarding all findings.
The FDA's investigational device exemption allows for a study to collect data on the safety and effectiveness of a system. This step must come before pre-market approval applications can be submitted to the FDA.
When treating breast cancer, patients may undergo one or all of the typical procedures, such as chemotherapy, radiation therapy, a lumpectomy to remove a breast lump or a mastectomy to remove all or part of the breast. According to the National Institutes of Health, cancer treatments are either local or systemic, involving the area of the disease or the entire body, respectively.