ETView Reports on Clinical Evaluation of VivaSight™
University Hospital Zurich, (Zurich, Switzerland) Evaluated VivaSight™ in 40 Patients Undergoing One Lung Ventilation. Results Demonstrate Elimination of Flexible Fiberoptic Bronchoscopy, and Reduction in Procedure Time
(25/02/15 Tel Aviv, Israel) ETView Medical Ltd. announced today 2 clinical reports on the use of VivaSight™ to achieve single lung isolation.
As reported in the January, 2015 issue of the Canadian Journal of Anesthesia1 , investigators at University Hospital Zurich, (Zurich, Switzerland) reported on "Intubation With VivaSight™ Or Conventional Left-Sided Double-Lumen Endotracheal Tubes (DLT): A Randomized Trial" which was performed on 40 patients. The primary objective of the investigation was to evaluate time to intubation. Secondary objectives focused on VivaSight™ insertion success without the need for flexible fiberoptic bronchoscopy during One Lung Ventilation (OLV), frequency of tube displacement, ease of insertion, quality of lung collapse, postoperative complaints, and airway injuries. The current standard of practice requires the use of flexible fiberoptic bronchoscopy to verify placement of endotracheal tubes during OLV procedures. Recent literature suggests associated flexible fiberoptic bronchoscope expenses from $1002 up to $2803 per surgical case.
According to the investigators of the current study, flexible fiberoptic bronchoscopy was eliminated when utilizing VivaSight™ to achieve OLV, compared with flexible fiberoptic bronchoscopy required in 100% of the cases which employed standard DLT to achieve OLV. Flexible fiberoptic bronchoscopy confirmed that in 15% of cases a standard DLT was misplaced during initial intubation, whereas no such cases occurred with the use of VivaSight™. Four of the conventional endotracheal tubes became displaced during placement and another two during surgical lung manipulation, each requiring repositioning under flexible fiberoptic bronchoscopy. In the VivaSight™ group repositioning was successful without the use of flexible fiberoptic bronchoscopy when tube displacement was detected in two patients during placement and in three of 19 cases during surgical lung manipulation. The authors referenced earlier citations noting that standard endotracheal tubes often become displaced after repositioning patients from the supine (intubating) to the lateral (operating) position. If not promptly identified and remedied, displacements can result in life-threatening complications and airway lacerations4. The authors concluded, " Successfully insertion of the VivaSight™ was faster than for a conventional endotracheal tube. Moreover, malpositioning was quickly detected and easily corrected without the need for additional flexible fiberoptic bronchoscopy. Continuous visualization of endotracheal tube position thus appears to provide clinical benefit."
1 Can J Anesth/J Can Anesth, DOI 10.1007/s12630-015-0329-8
2 Journal of Anesthesia and Clinical Research, 3:215. doi:10.4172/2155-6148.1000215
3 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.
The current study compares favorably to earlier findings by investigators at the Leiden University Medical Center (Leiden, Netherlands) and Haga Hospital (The Hague, Netherlands) reported during the 2014 European Society of Thoracic Surgeons Meeting5 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™ reduced time to achieve (OLV) by 22% when compared to surgical procedures which utilized flexible fiberoptic bronchoscopy. Furthermore, associated expenditures on a per surgery basis were reduced by at least 17% when using VivaSight™-DL vs. surgical cases employing standard DLT due to the additional pre-procedure cost of flexible fiberoptic bronchoscopy.
In addition, recently published findings6 by investigators at MD Anderson (Houston, TX), demonstrated that the use of flexible fiberoptic bronchoscopy was not required either for initial VivaSight™ placement or for correct placement verification upon final patient positioning, in over 93% of patients evaluated.
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 July 9, 2014, ETView Medical Ltd., reported on 2 Clinical Evaluations of VivaSight™, conducted at MD Anderson (Houston, TX) and Haga Hospital (The Hague, Netherlands.
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 22, 2013, ETView Medical, Ltd., announced an exclusive distribution agreement with MEDITRADE al. s ro, (MEDITRADE) to market ETView's VivaSight™ products in Slovakia, Czech Republic and Poland.
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.
4 Anesthesiology 1987; 67: 255-7.
5 Copenhagen, Denmark, June 15-18, 2014
6 J Cardiothorac Vasc Anesth. 2014 Aug;28(4):882-4. doi: 10.1053/j.jvca.2013.11.011. Epub 2014 Mar 20
About ETView Medical, Ltd.
ETView Medical Ltd. has successfully combined airway management with continuous direct airway visualization for medical professionals. ETView's patented VivaSight™7 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 in Europe, Israel, and the US 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 surgeries8.
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 isolation9. It is estimated that over 1.9 million lung isolation procedures are conducted worldwide annually10, accounting for over $250 million in single-use medical disposables11. 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 bronchoscope12 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.
7 Patents issued and pending
8 Principles and Practices of Anesthesia for Thoracic Surgery. P. Singer (ed.) 2011
9 Anesthesia & Analgesia. 2009;108:1097–101
10 National Health Statistics Reports Number 29, October 26, 2010
11 Company estimates on file
12 Minerva Anestesiol. 2009;75 (Suppl 1):1-4.