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Vision Sciences receives FDA clearance for new EndoSheath product

MassachusettsMonday, July 21, 2003, 08:00 Hrs  [IST]

Vision-Sciences Inc has received clearance to market its new Slide-On EndoSheath System for Sensory Testing used in conjunction with flexible ENT (Ear, Nose and Throat) endoscopes from the US Food and Drug Administration (FDA). The Slide-On EndoSheath System for Sensory Testing is an alternative to a modified barium swallowing study that eliminates the need for fluoroscopy and exposure to X-rays, and can be performed as an office procedure. The exam is used to help diagnose acid reflux disease and swallowing disorders that could lead to aspiration pneumonia. It is estimated that 40 million people in the United States suffer from some form of acid reflux disease affecting a portion of the vocal cords, esophagus and/or stomach. Ron Hadani, President and CEO of Vision Sciences, stated that, "This innovative product offers otolaryngologists, gastroenterologists, pulmonologists and speech pathologists the simplest and most economical way to perform sensory testing as it eliminates the required purchase of an additional specialized endoscope. The Sensory Sheath expands the use of the large installed base of diagnostic ENT scopes as it slides directly onto all the commonly used models and provides the required air channel. The sensory test procedure is performed in the physician's office by introducing small puffs of air that are passed through the sheath. The air puffs elicit a reflex response from the vocal cords, and provide diagnostic information useful in the detection of acid reflux disease and swallowing disorders." The technology for this product was developed by Vision Sciences. The FEESST procedure was developed at the College of Physicians and Surgeons of Columbia University.

 
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