First Video-Based Endoscopy Approved
The FDA granted marketing clearance to Vision-Sciences, Incorporated for their new line of video-based endoscopes that incorporate a built-in light source. Two different products are currently offered, the ENT-5000 (Ear, Nose, and Throat) and the TNE-5000 (Transnasal Esophagoscopy). The launch was detailed on Yahoo Finance.
The advanced digital, video-based flexible endoscopes represent a new, unique line for the digital endoscopy platform. The scopes also contain the smallest diameter insertion tube. The tube contains a tiny, high resolution charge coupled device (CCD) attached to the end of the insertion tube. This component provides excellent visualization with a sharp, high definition full screen image.
Another advantage of the new system is that it does not include operating channels which are traditionally challenging for sterilization. The new endoscopes can be used with the company’s line of Slide-On EndoSheath technology, which encases the entire endoscope. This isolates the product from direct contact with the patient and contains a disposable operative channel. These components prevent contact between the endoscope and patient tissue biopsies or instrumentation.
This technology prevents the need for disinfection between procedures, which allows a shorter time period in between endoscopies with the same piece of equipment. This also allows facilities to invest in fewer endoscopes. Limited cleanings additionally reduce toxic exposure to the personnel responsible for sterilization of equipment. The EndoSheath barrier is effective against microorganisms as small as 27 nanometers, which is the FDA benchmark for barriers.
One of the advantages of the new endoscope is that it integrates multiple components. The addition of these pieces mitigates the need for a light cable, optical coupler, and separate camera head. The organization suggests that this new means to examine endoscopically will eventually replace fiberoptic technology which is currently used.
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September 18, 2007 Related topics: Product Launches, Product Approval & Certification, Otolaryngology, Gastroenterology, Endoscopy