New Peer-Reviewed Publication Demonstrates Patient Safety Aspects of
Vision-Sciences' EndoSheath(R) Technology for Flexible Cystoscopes
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:
*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.
*100% of microbiology samples showed a clean flexible cystoscope following
EndoSheath technology usage and the Company's recommended cleaning
*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
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
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
CONTACT: Keith Darragh
VP Finance, Principal Accounting Officer,
and Principal Financial Officer
In-Site Communications, Inc.
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