ORANGEBURG, N.Y., Nov. 6, 2013 (GLOBE NEWSWIRE) -- Vision-Sciences, Inc. (Nasdaq:VSCI) announced today the publication of positive outcomes of a clinical study that evaluated the durability and microbial barrier properties of the Company's EndoSheath® technology in the flexible cystoscopy setting in the November issue of the peer-reviewed journal BMC Urology.
To assess the efficacy of Vision-Sciences' EndoSheath technology with flexible cystoscopes, study authors tested the barrier integrity of each EndoSheath disposable following clinical procedures and then performed microbiology sampling of the flexible cystoscopes to determine if any bacterial contamination had occurred. Study outcomes and conclusions include:
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100% of EndoSheath units tested were leak-free following clinical use. This finding confirms outcomes of a prior study of 875 endoscopic procedures in which no leaks were reported.
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100% of microbiology samples showed a clean flexible cystoscope following EndoSheath technology usage and the Company's recommended cleaning procedure.
- The study authors concluded that Vision-Sciences' reprocessing procedure featured a low risk of pathogen transmission, high-patient safety and a valid alternative to the recommended high-level disinfection procedure of competitive flexible cystoscopes.
"This was the first research to assess the microbiology and sheath integrity of our EndoSheath technology in the cystoscopy setting. These highly positive results demonstrate that the EndoSheaths did not break, and that the use of our EndoSheath technology followed by our three-step cleaning process has a low risk of pathogen transmission and high patient safety. This supports our longstanding position that the EndoSheath technology provides an 'always ready, always sterile' endoscope," said Howard Zauberman, Vision-Sciences' Interim Chief Executive Officer.
The study, entitled "A microbiological evaluation of level of disinfection for flexible cystoscopes protected by disposable endosheaths," was conducted by researchers in Denmark at the Frederiksberg University Hospital, Hvidovre University Hospital, and University of Copenhagen. Microbiological samples from 100 cystoscopies performed with flexible cystoscopes ("FC") using disposable sterile EndoSheaths were obtained twice: after removal of the EndoSheath, and after cleaning the scope with a detergent cloth, rinsing with tap water followed by 70% ethanol disinfection, and subsequent drying.
The number of colony forming units ("CFU") from the samples was counted after 72 hours and then divided into three categories: Clean FC ( < 5 CFU/sample); Critical FC (5-50 CFU/sample); and High-risk FC ( > 50 CFU/sample). This result was compared with data of 10 years continuous control sampling recorded in the Copenhagen Clean-Endoscope Quality Control Database ("CCQCD") and analyzed with a Chi-square test for homogeneity.
All samples obtained after removal of the EndoSheath and after cleaning and alcohol disinfection, both from the maneuver part and insertion part of the FC, showed a Clean FC with a mean of 0.2 CFUs; the few bacteria identified originated from skin commensals, and were found in a few samples taken both before and after reprocessing the FC. As no leak was detected, study authors concluded that the contamination likely resulted from the handling of the FC or from sampling procedures. Leak testing during the study utilized a pressure decay system (Uson, Houston, TX).
The complete scientific article is available at http://www.biomedcentral.com/1471-2490/13/46
Citation: Peter Hjorth Jørgensen, Slotsbjerg T et al. A microbiological evaluation of level of disinfection for flexible cystoscopes protected by disposable endosheaths. BMC Urology 2013, 13:46 doi:10.1186/1471-2490-13-46.
About Vision-Sciences, Inc.
Vision-Sciences, Inc. designs, develops, manufactures and markets products for flexible endoscopy. The company's unique product lines feature a streamlined visualization system and proprietary sterile disposable microbial barrier, known as EndoSheath® technology, providing users with efficient and cost effective endoscope turnover while enhancing patient safety. Information about Vision-Sciences' products is available at www.visionsciences.com.
Vision-Sciences owns the trademarks Vision Sciences™ and Slide-On™ and the registered trademarks EndoSheath®, EndoWipe® and The Vision System®.
The Vision-Sciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3876
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements, which are any statements that are not historical facts. These forward-looking statements are based on Vision-Sciences' current expectations, and should not be relied upon as representing its views as of any subsequent date. Forward-looking statements are subject to a variety of risks and uncertainties that could cause the Company's actual results to differ materially from the statements contained herein; risk factors are detailed in the Company's most recent annual report and other filings with the U.S. Securities and Exchange Commission. There is no assurance that any future results or events discussed in these statements will be achieved. The Company does not assume any obligation to update any forward-looking statements as a result of new information or future events or developments, except as may be required by law.