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FDA grants approval for CivaTech’s brachytherapy device

CivaTech Oncology has obtained approval from the US Food and Drug Administration for its CivaSheet brachytherapy device.

The implantable CivaSheet low dose rate (LDR) Palladium is a membrane-like bioabsorbable, planar radiation device, which provides uni-directional option to shield healthy tissue and is customized to a specific patient’s condition.

The device has been developed for use either during surgery or with standard, less invasive and implant devices.

CivaSheet’s ability to customize directionality in a planar configuration will allow radiation oncologists to treat different cancers such as soft tissue sarcoma, early-stage non-small-cell lung cancer, head and neck cancer, colorectal cancer, ocular melanoma, and skin cancer.

CivaTech Oncology executive chairman and CEO Suzanne Babcock said: "We are very excited about the beneficial impact this can have for all of the patients whom are candidates for this new treatment option.

"For the first time, radiation oncologists will have a configurable planar LDR array that is truly customizable to a specific patient’s condition, allowing clinicians to specify a tailor-made dose distribution that can be unidirectional or bi-directional."

Earlier, the company also received FDA 510k approval for its CivaString for therapeutic use in localized tumor sites.