One-Year Study Demonstrates Vision-Sciences' EndoSheath Technology Protects
Against Bacterial Contamination of Bronchoscopes
Compelling Data Presented at SIAARTI 67th National Congress
ORANGEBURG, N.Y., Oct. 22, 2013 (GLOBE NEWSWIRE) -- Vision-Sciences, Inc.
(Nasdaq:VSCI) announced today that the detailed findings of a twelve-month
evaluation of its EndoSheath^® technology in the critical care setting were
presented by Dr. Flavia Petrini, Professor of Anaesthesia and Intensive Care,
Università Gabriele d'Annunzio Chieti-Pescara (Italy), in a scientific poster
at the 67^th National Congress of the Società Italiana di Anestesia Analgesia
Rianimazione e Terapia Intensiva (SIAARTI).
Of the 53 bronchoscopy cases conducted there were no cases of bacterial
contamination of bronchoscopes, excluding two deliberate contaminations by the
bronchoscopists for control purposes. "These highly positive study outcomes
add to the growing body of data on the microbiology validation of our
EndoSheath technology, and further support the advantages of using our
sterile, disposable technology over conventional, difficult to clean and
disinfect endoscopes," stated Howard Zauberman, Interim Chief Executive
Officer of Vision-Sciences.
This study was conducted by researchers at the Università Gabriele d'Annunzio
Chieti-Pescara Hospital Intensive Care Unit (ICU) to examine the impact of the
EndoSheath technology on reducing the bacterial contamination of the
bronchoscopes and the potential for eliminating the need of routine high-level
disinfection (HLD) in reprocessing. During the twelve-month study period,
investigators used Vision-Sciences' bronchoscope with EndoSheath technology to
perform bronchoscopic procedures (n=53) including bronchial aspirate (BAS)
(n=19), bronchoalveolar lavage (BAL) (n=31), and percutaneous tracheostomy
(PCT) (n=3). The device was cultured three times for each procedure: before
the application of the EndoSheath; after the procedure and removal of the
EndoSheath; and, after enzymatic cleaning, drying and disinfection with 70%
ethanol.A sterile pledget was wiped on the entire surface of the insertion
tube and a second one on the entire surface of the control head. Both were
placed in sterile specimen containers for culture.
The operator deliberately contaminated two (3.8%) results for control purposes
by touching several areas and other devices in the ICU.As expected, these two
results tested positive for bacterial contamination with Staphylococcus (CoNS)
or Sphingomonas paucimobilis.The remaining 51 procedures (96.2%) tested
negative for bacterial contamination.
Overall performance of the device was also measured by the bronchoscopist
after each procedure using a semi-quantitative linear score (0=minimum;
5=maximum).The device was judged positively for performance in terms of
visualization (deﬁned by clarity of the image and brightness), suitability
(deﬁned by general comfort and easiness of use) and function usefulness
(deﬁned by potency of aspiration and injection, tip movements). The mean
scores for these criteria were as follows:
Visualization 3.9 (95% CI: 2.2-5.6)
Suitability 3.0 (95% CI: 1.6-4.4)
Function usefulness 3.1 (95% CI: 1.7-4.5)
A comparative study is planned to confirm this data on bacterial reduction.
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 Vision-Sciences' 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.Vision-Sciences 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
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