SAN JOSE, Calif., June 28, 2007 (PRIME NEWSWIRE) -- Results of an award-winning clinical study presented Wednesday, June 27th at the annual meeting of the Association for Professionals in Infection Control and Epidemiology (APIC), suggest sterile barrier sheaths may eliminate the need for nasendoscopes high-level disinfection.
The study was conducted at an ambulatory Ear, Nose and Throat ("ENT") clinic using standard 30 cm flexible nasendoscopes and the disposable, sterile EndoSheath(r) System ("Sheaths"). During the study, one hundred flexible endoscopies using the sterile EndoSheath barrier were performed. Each sheath was evaluated for integrity, and each nasendoscope was evaluated for bacterial contamination after use in patients.
For the study, each patient-ready endoscope was cultured:
* PRIOR to its use, for a baseline evaluation of insertion tube and control head; * AFTER use and removal of the EndoSheath barrier; and * POST REPROCESSING (disinfection).
Immediately after use, the EndoSheath was removed and leak tested, confirming that there were no tears or holes created during use. Additionally, 20 unused sheaths were also leak-tested to assess the possibility of pre-use leaks. All sheaths passed the leak test, confirming no failures.
The study showed that following the use of the EndoSheath and an enzymatic detergent cleaning and ethanol disinfection procedure, the scopes were negative for any bacterial presence.
"In our study results, the nasendoscopes fitted with the sterile EndoSheath system in combination with thorough post-use enzymatic detergent cleaning followed by a 70% ethanol wipe, provided a patient ready instrument equivalent to high-level disinfection," stated Carla J. Alvarado, Ph.D., a research scientist in human factors engineering at the Center for Quality and Productivity Improvement, University of Wisconsin-Madison and lead researcher on the study. "In this particular use environment, it provides an alternative to chemicals requiring more time and labor intensive processes."
Dr. Alvarado received the APIC-sponsored 2007 William A. Rutula Award for her abstract. The award is given to an APIC member whose abstract most closely reflects the excellence demonstrated by William A. Rutula, a world-renowned expert in disinfection.
"The premise that the EndoSheath System is an effective barrier to bacterial presence is further validated by Dr. Alvarado's independent study," stated Ron Hadani, CEO of Vision-Sciences. "Along with enhancing healthcare practice efficiency, the technology allows for minimizing patient and employee exposure to harsh chemicals generally required for endoscope reprocessing. We also believe that the compelling data shown in this study reflects the benefits of our EndoSheath product lines in urology, gastroenterology and future endoscopic applications."
The EndoSheath System is manufactured by Vision-Sciences (www.visionsciences.com), and distributed by Medtronic Inc. for the ENT market.
About Vision-Sciences
Vision-Sciences, Inc. (Nasdaq:VSCI) develops, manufactures and markets unique flexible endoscopic products for the urology, gastroenterology and the ENT markets, utilizing the sterile disposable EndoSheath System. This technology provides quick and efficient equipment turnover, and ensures the patient a contaminant-free endoscope insertion.
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Any forward-looking statements are subject to risks and uncertainties such as those described in our Annual Report on Form 10-K for the year ended March 30, 2007. Actual results may differ materially from anticipated results.