TEL AVIV, Israel--(BUSINESS WIRE)--ETView Medical Ltd. announces 2 clinical reports on the use of VivaSight™ to achieve single lung isolation.
As reported in the March, 2014 issue of the Journal of Cardiothoracic Anesthesia, investigators at MD Anderson (Houston, TX) reported on "A Retrospective Evaluation of the Use of Video-Capable Double-Lumen Endotracheal Tubes in Thoracic Surgery" which was performed on 29 patients. The primary objective of the investigation was to evaluate whether the use of the VivaSight™ DL reduced the need for fiberoptic bronchoscopy during One Lung Ventilation (OLV). The current standard of practice requires the use of fiberoptic bronchoscopy to verify placement of endotracheal tubes during One Lung Ventilation procedures. According to the investigators, the use of fiberoptic bronchoscopy was not required either for initial VivaSight™ DL placement or for correct placement verification upon final patient positioning, in over 93% of patients evaluated.
Investigators at the Leiden University Medical Center (Leiden, Netherlands) and Haga Hospital (The Hague, Netherlands) recently reported during the European Society of Thoracic Surgeons Meeting1 on "The VivaSight™ DL for VATS [Video Assisted Thoracic Surgeries], Reducing surgery time and costs." After analyzing the results from 201 cases, the investigators concluded that VivaSight™ DL reduced time to achieve OLV by 22% when compared to surgical procedures which utilized fiberoptic bronchoscopy. Further, associated expenditures on a per surgery basis were reduced by 17% when using VivaSight™ DL vs. surgical cases employing fiberoptic bronchoscopy.2 The investigators also commented that in comparison to lung-isolation procedures employing a regular single-lumen endotracheal tube, a bronchial-blocking catheter and a fiberoptic bronchoscope, the use of the VivaSight™ DL reduces the cost by up to 51.6%. The investigators plan to submit for publication, the entirety of their findings, during 2014.
William Edelman, CEO of ETView Medical, commented, “We are pleased to see clinical data supporting the need for VivaSight™ reach the clinical community.” Mr. Edelman continued, “We look forward to future clinical studies, which focus on the benefits of VivaSight™ in thoracic surgical procedures. VivaSight™ products are distributed in Europe, Asia, and the United States. VivaSight™ provides best-in-class airway management solutions for sophisticated thoracic surgical procedures requiring lung isolation.”
On May 7, 2014, ETView Medical Ltd. announced an exclusive distribution agreement with Technolab CIA LTDA to exclusively market ETView's VivaSight™ products in Ecuador.
On May 7, 2014, ETView Medical Ltd. announced an exclusive distribution agreement with MedCARE Medizintechnik Vertrlebs GmbH to exclusively market ETView's VivaSight™ products in Austria.
On September 23rd, 2013, ETView Medical Ltd. announced an exclusive distribution agreement with Gil Medical, to market ETView's VivaSight™ products in Israel.
On June 10, 2013, ETView Medical Ltd. announced an exclusive distribution agreement with Clinical Technologies, Inc., to market ETView's VivaSight™ products in the US states of North Dakota, South Dakota, Nebraska, Kansas, Missouri, Iowa, Minnesota, Wisconsin, Illinois, Kentucky, Indiana, Ohio, Michigan, and West Virginia.
On May 6, 2013, ETView Medical Ltd. announced an exclusive distribution agreement with Mercury Medical, Inc., to market ETView's VivaSight™ products in Florida, Georgia, South Carolina, North Carolina, Virginia, Maryland, District of Columbia, Tennessee, Arkansas, Alabama, Mississippi, Louisiana, Texas, and Oklahoma.
On March 30, 2013, ETView Medical Ltd. announced US FDA Clearance of a 510(k) Pre-marketing Notification Application expanding the VivaSight™ DL line of innovative airway devices.
On March 18, 2013, ETView Medical Ltd. announced State Food and Drug Administration (SFDA, China) Clearance of a Pre-marketing Notification Application for the VivaSight™ SL line of innovative airway devices.
About ETView Medical, Ltd.
ETView Medical Ltd. has successfully combined airway management with continuous direct airway visualization for medical professionals. ETView's patented VivaSight™3 airway management portfolio consists of single-use disposable single and double lumen ventilation tubes with an integrated continuous high resolution airway imaging system. VivaSight™ SL and VivaSight™ DL are currently sold worldwide to overcome current limitations and associated adverse surgical events during lung isolation surgeries. Lung isolation is employed to provide one-lung ventilation in patients undergoing thoracic, cardiac, vascular, or esophageal surgeries.4
Typically, during lung isolation, temporary visualization of the patient airway is achieved with a fiberoptic bronchoscope while the patient is ventilated and the target lung isolated. Such intra-operative surgical maneuvers often require repeated imaging and partial blocking of the airway to maintain lung isolation.5 It is estimated that over 1.9 million lung isolation procedures are conducted worldwide annually,6 accounting for over $250 million in single-use medical disposables.7 ETView has developed the VivaSight™ platform, combining an airway ventilation tube with integrated continuous high resolution airway imaging for patient airway management and lung isolation capability, eliminating the need for fiberoptic bronchoscope8 imaging for intubation and airway monitoring in lung isolation procedures.
The Company estimations in this press release, including those estimations regarding the Company's predicted scope of business, constitute forward-looking statements, as such term is defined under the Israeli Securities Law (5728-1968), and there is no certainty that such estimations shall materialize. The Company's estimations are based on business assumptions, prior experience, and professional data. Due to various factors, foreseen and unforeseen, including, but not limited to, changes in market trends, competition, global or local economic conditions, and amendments of regulation, such estimations may not materialize in whole or in part, or materialize in a substantially different manner than anticipated by the Company.
1 Copenhagen, Denmark, June 15-18, 2014
2 Recent literature suggests associated fiberoptic bronchoscope expenses from $100 (Journal of Anesthesia and Clinical Research, 3:215. doi:10.4172/2155-6148.1000215) up to $280 (Annals of French Anesthesia and Intensive Care, 2013 May;32(5):291-5. doi: 10.1016/j.annfar.2013.01.014. Epub 2013 Apr 3) per surgical case
3 Patents issued and pending
4 Principles and Practices of Anesthesia for Thoracic Surgery. P. Singer (ed.) 2011
5 Anesthesia & Analgesia. 2009;108:1097–101
6 National Health Statistics Reports Number 29, October 26, 2010
7 Company estimates on file
8 Minerva Anestesiol. 2009;75 (Suppl 1):1-4.