The BioZorb™ three-dimensional surgical marker dramatically improves visualization of the treatment area for radiation planning and therapy, according to a presentation at the prestigious San Antonio Breast Cancer Symposium 2013.
The scientific poster reports that the tissue marker is easy to place, safe to use and well tolerated by patients. In the presentation, a series of consecutive early-stage breast cancer patients was implanted with the device at the time of lumpectomy. The 3D BioZorb marker was reported to provide clinical advantages for surgeons and radiation oncologists.
"This device could represent a quantum leap in the ability to mark tissue for radiation treatment after surgery," said Christopher Glaser, MD, FACS, the lead author on the poster presentation. Dr. Glaser and poster co-author John Falcone, MD, are surgeons at Mitchell Memorial Cancer Center and Owensboro Health Surgical Specialists, in Owensboro, Ky.
Targeted delivery of radiation therapy helps to prevent recurrence of cancer and is a vital part of breast conserving therapy, the authors note. Currently, there is no standardized, accurate method for marking the surgical site of tumor removal, which makes post-operative radiation planning difficult. Methods typically used for radiation planning may overestimate the volume of the treatment area, and may result in excess radiation exposure to normal tissues such as the heart and lungs, causing inadvertent complications.
"Our radiation oncologists love this thing," said Glaser. Because the marker is placed directly into the surgical cavity at the time of tumor removal and sutured in place, it is very reliable. "The visual difference between BioZorb targeting and traditional methods of targeting is dramatic," noted Dr. Glaser. The marker's unique features make it easily visualized as a clear target site, helping to decrease the amount of breast and adjacent tissues exposed to radiation.
The unique open-spiral design of the BioZorb marker incorporates six permanent titanium clips in a fixed three-dimensional array and provides specific landmarks at the site of the excised tumor. This poster and other clinical presentations note that the BioZorb marker is useful for radiation treatment planning, patient positioning during treatment, and the ability to facilitate advanced methods of radiation treatment.
BioZorb has been used successfully in both the U.S. and New Zealand. It is made of a bioabsorbable material commonly used in other medical devices, and allows the patient's body to absorb the material slowly, so it does not require surgical removal after treatments are completed.
BioZorb has received 510(k) clearance from the U.S. Food and Drug Administration. The device is available in a range of sizes to accommodate a variety of clinical situations.