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Back To Vidyya FDA Approves New Device

New Device Helps Identify Colon Growths

The FDA today approved a laser system to improve a physician's ability to distinguish small harmless growths from pre-cancerous growths in the colon.

The device, made by SpectraScience, Inc. of Minneapolis, uses laser light energy. The product, the Optical Biopsy System, is operated through an endoscope and can be used during either sigmoidoscopy or colonoscopy to evaluate polyps less than 1 cm in diameter that the physician has not already decided to remove.

It is intended to be used only when physicians would not otherwise remove all visualized polyps. When used by physicians who base removal of polyps on their visual assessment, the device helps them to decide which polyps should be removed and sent for microscopic examination and which can safely be left alone. It is not intended to be used as a stand-alone device and should not be used to replace the physician's judgement in the removal of colonic polyps.

The Optical Biopsy System consists of a laser source, an optical fiber, analytical software and a user-interface console. The system shines laser light through the optical fiber onto the target growth in the colon. The light energy is absorbed by the polyp. In response, the polyp emits light energy that is sent back through the optical fiber, returned to the machine, and analyzed by the system software. Based on a series of computations that are performed by the software, the system indicates whether or not the polyp is suspicious for having the potential to become malignant.

Approval of the device was based on FDA's review of clinical studies of safety and effectiveness conducted by SpectraScience and on the recommendation of the Gastroenterology and Urology Devices Panel of FDA's Medical Devices Advisory Committee.

SpectraScience studied use of the device in 101 patients with 135 polyps at five medical centers in the United States. In the study, the device increased the physicians' accuracy in correctly identifying pre-cancerous polyps from 82 to 96 percent. At the same time the device decreased the physicians' accuracy in correctly identifying non-cancerous polyps from 50 to 33 percent. Since the starting point of any particular physician's accuracy may differ from that of the few physicians who participated in the study, the device's effect in changing a physician's accuracy may differ from the results shown in this study. No adverse events were reported from use of the device.

Use of the Optical Biopsy System is restricted to physicians who have been trained in endoscopy and in the proper use of the device.

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Editor: Susan K. Boyer, RN
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