Focal Therapeutics BioZorb Tumor Localization Women's Health Oncology Related

March 6, 2014 — The BioZorb 3-D surgical marker improved targeting for radiation therapy by enhancing visualization of the breast cancer lumpectomy cavity. This is according to a presentation at the 2014 Breast Cancer Coordinated Care (BC3) conference in Washington D.C.

The scientific poster reported that substantial advantages were observed when the tissue marker was used with both post-operative radiation boost therapy and partial breast irradiation (PBI).

The study, which involved 22 patients, compared the use of the 3-D tissue marker to traditional tissue landmarks such as seroma and clips as well as post-operative density changes seen on treatment planning CT scans.

"Overall, this tissue marker allowed us to achieve more than a 50 percent reduction in the planned treatment volume," said poster co-author Robert R. Kuske, Jr., M.D., a radiation oncologist at Arizona Breast Cancer Specialists. "With the BioZorb in place we didn't have the guesswork that we have with traditional markers, so we had confidence that we were only irradiating the minimum tissue necessary. This means better results for our patients and also less risk to healthy tissue near the surgical cavity."

Besides the improvement in target volume delineation, the researchers reported that all patients tolerated placement of BioZorb without complications and cosmetic outcomes were excellent.

Previously, there was no standardized method for marking the surgical site of tumor removal, which made post-operative radiation planning difficult. Methods typically used for radiation planning may overestimate the treatment area volume, and may result in excess radiation exposure to normal tissues such as the heart and lungs. This can cause inadvertent complications. 

The open-spiral design of the BioZorb marker incorporates six permanent titanium clips in a fixed 3-D array and provides specific landmarks at the site of the excised tumor. This poster indicates BioZorb marker as useful for radiation treatment planning, patient positioning during treatment and the ability to facilitate advanced methods of radiation treatment, such as respiratory gating.

BioZorb has been used successfully in the United States and New Zealand. It is made of a bioabsorbable material commonly used in other medical devices. It allows the patient's body to absorb the material slowly, so it does not require surgical removal after treatments are completed.

BioZorb received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The device is available in a range of sizes to accommodate a variety of clinical situations.

For more information: www.focalrx.com


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