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FDA Clears Targeted Breast Cancer Radiation Treatment

MRI of breast

MRI of breast (National Cancer Institute)

27 December 2017. The U.S. Food and Drug Administration approved a device that sends high doses of radiation to cancerous breast tissue while sparing healthy tissue nearby. FDA approved the device known as GammaPod, made by Xcision Medical Systems LLC in Columbia, Maryland, and invented by researchers at University of Maryland medical school in Baltimore.

The GammaPod system is designed to take advantage of advances in breast cancer diagnostics that spot the disease in its early stages, while the cancer is still confined to breast tissue or nearby lymph nodes, but before it spreads to other parts of the body. In this early stage, radiation treatment can kill tumor cells in the breast and damage their DNA, but the radioactive emissions can also harm healthy tissue near the tumor. FDA estimates 60 percent of cancer patients are treated with some form of radiation therapy.

The GammaPod is an invention of radiation cancer specialists Cedric Yu and William Regine at University of Maryland. The device encases and immobilizes the breast while 36 rotating cobalt-60 sources send thousands of radioactive beams into the diseased tissue. “With this breast-specific treatment system,” says Regine in a university statement, “we will be able to deliver high-dose radiation to a tumor while minimizing damage to normal breast tissue and even more importantly, to major organs such as the heart and lungs.”

FDA based its clearance of GammaPod, announced on 22 December, in part on a clinical trial testing the feasibility and safety of a prototype device at University of Maryland Medical Center. The results of the trial from its 17 participants show the device delivers the prescribed dose of radiation to the tumor, while minimizing common side effects from radiation, such as skin redness. FDA points out, however, that GammaPod is not shown to be more effective than whole breast radiation therapy and not intended to replace this treatment.

The agency reviewed GammaPod using its 510(k) prenotification pathway. In this process, a medical device developer demonstrates to FDA that the new system is substantially equivalent to an earlier legally marketed device.

Yu founded Xcision Medical Systems in 2006 to commercialize GammaPod, and serves as the company’s CEO. “We envision that one day we’ll be able to neutralize a tumor with a high dose of focused radiation instead of removing it with a scalpel,” notes Yu. “This approach would spare patients the negative side effects of surgery and prolonged radiation treatments, significantly improving their quality of life.”

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