WRAL TV from Raleigh, North Carolina is reporting that a local company Sicel Technologies, Inc. has received clearance from the FDA to market its DVS® (Dose Verification System), a wireless, 2 mm x 18 mm implantable radiation sensor and reader. The medgadget functions as a patient dosimetry verification system, specifically designed for radiation oncology therapy.
Company describes its innovative product:
… the U.S. FDA. FDA clearance was based upon successful completion of a multi-center clinical study of breast cancer patients most of who were implanted with two DVS(R) sensors prior to receiving radiation therapy. Using the hand held reader, physicians were able to determine the actual dose of radiation being delivered to the tumor after each course of therapy. Implantation of the DVS(R) sensor did not lead to any adverse events in the clinical trial.
DVS(R) is the first permanently implantable, wireless, telemetric, radiation sensor for human use to be commercially available in the United States. “We believe DVS(R) represents breakthrough technology that provides significant benefit both to the patient as well as to the oncologist treating the patient,” said Michael Riddle, President & CEO of Sicel Technologies, Inc. He added, “The Company is in the process of completing manufacturing up fit for the device and anticipates beginning to take orders and ship product in the third quarter.”
Dr. Charles Scarantino, Principal Investigator for the DVS(R) clinical trial, commented, “Implantation of the DVS(R) sensor is straightforward and safe. I believe that over time this important new technology may demonstrate its value by helping physicians not only confirm the exact location of the tumor but also confirm that the prescribed dose of radiation has been accurately delivered.” Using proprietary telemetric technology, Sicel’s miniature DVS(R) sensor (20mm x 2mm) provides the unique capability not only to pinpoint the target during a patient’s treatment cycle but also to measure the amount of radiation received by the tumor. Almost every cancer center has the equipment required to visualize the DVS(R) sensor without the need to purchase additional capital equipment. Today’s highly-conformal radiation therapy treatment options rely on knowing the exact location of the tumor to be treated. While there are several methods available to facilitate tumor localization, none provide actual dose information. Deviations in dose received by the tumor, or accidentally administered to normal tissue, can have a serious impact on long term survival rates and quality of life for the more than 650,000 patients treated annually with radiation therapy.