Healthcare Industry News:  endotracheal tube 

Devices

 News Release - September 21, 2015

ETView and The University of Texas MD Anderson Cancer Center (Houston, TX) Announce the Start of a Prospective, Randomized Clinical Evaluation of VivaSight-DL(TM) vs. Standard Double-Lumen Endotracheal Tubes

The University of Texas MD Anderson Cancer Center (MDACC) will Evaluate VivaSight-DL™ vs. Standard Double-Lumen endotracheal tubes in Patients Undergoing One Lung Ventilation (OLV) Procedures

Clinical Trial, Titled, "Prospective Randomized Study on Video Double-Lumen Tube versus Double-Lumen Tube," will be Supervised by Jagtar Singh Heir1, M.D., who will Serve as Principal Investigator


TEL AVIV, Israel--(Healthcare Sales & Marketing Network)--ETView Medical Ltd. announced today initiation of a prospective, randomized clinical evaluation on the use of VivaSight-DL™ to achieve One Lung Ventilation (OLV) at The University of Texas MD Anderson Cancer Center (Houston, TX). The objectives of the clinical trial, titled, "Prospective Randomized Study on Video Double-Lumen Tube versus Double-Lumen Tube," include assessment of time to achieve OLV, improvements in clinical workflow and economic impact of utilizing VivaSight-DL™ vs. standard double-lumen endotracheal tubes in the establishment and management of OLV during surgical cases where OLV is required. Final clinical results are not expected for several quarters.

William Edelman, CEO of ETView Medical commented, “We are thrilled to initiate this clinical evaluation of VivaSight-DL™ in collaboration with The University of Texas MD Anderson Cancer Center. The growing body of clinical evidence supports VivaSight-DL™ as the best-in-class solution for conducting one lung ventilation procedures. Wherever VivaSight-DL™ is implemented, fiberoptic bronchoscopy is significantly reduced with associated economic benefits and improved clinical procedural workflow.” Mr. Edelman continued, “VivaSight™ is currently being distributed across Europe, Asia and the United States. Single-use VivaSight™ provides best-in-class airway management solutions for thoracic surgical procedures requiring One Lung Ventilation (OLV), and eliminates patient cross-contamination associated with the sterilization2,3,4 of imaging devices."

Prior Announcements

On April 27, 2015, ETView reported results of a Multi-Center Clinical Evaluation of VivaSight-DL™ demonstrating significant reduction in associated fiberoptic bronchoscopy use, substantial economic benefit and improved procedure workflow.

On March 23, 2015, ETView announced expansion of China distribution with execution of Well Lead Medical Co., Ltd., Distribution Agreement.

On February 24, 2015, ETView reported on Clinical Evaluation of VivaSight™ at the University Hospital Zurich (Zurich, Switzerland).

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 exclusive distribution agreements with Technolab CIA LTDA and with MedCARE Medizintechnik Vertrlebs GmbH to exclusively market ETView's VivaSight™ products in Ecuador and in Austria (respectively).

About MD Anderson

The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. MD Anderson is one of only 41 comprehensive cancer centers designated by the National Cancer Institute (NCI). For the past 25 years, MD Anderson has ranked as one of the nation's top two cancer centers in U.S. News & World Report's annual "Best Hospitals" survey. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

About ETView Medical, Ltd.

ETView Medical Ltd. has successfully combined airway management with continuous direct airway visualization for One Lung Ventilation (OLV). OLV is employed to provide one-lung ventilation in patients undergoing thoracic, cardiac, vascular, or esophageal surgeries.5 ETView's VivaSight™ airway management portfolio combines single-use disposable single and double lumen ventilation tubes with integrated continuous high resolution airway imaging. VivaSight™-SL and VivaSight™-DL are sold worldwide to overcome current limitations and associated adverse surgical events during OLV surgeries.

As reported in the March, 2015 issue of Anaesthesia6, investigators at VU University Medical Centre, Amsterdam, The Netherlands; Medical Centre Alkmaar, Alkmaar, The Netherlands; Catharina Hospital, Eindhoven, The Netherlands; and Rambam Health Care Campus, Haifa, Israel, reported on “Evaluation of a new double-lumen endobronchial tube with an integrated camera (VivaSight-DL™): a prospective multicentre observational study,” which was performed on 151 patients. The authors reported a 87% reduction in fiberoptic bronchoscopy when VivaSight-DL™ was employed for OLV, similar to a prior published study7 describing a reduction of 93% in the use of fiberoptic bronchoscopy for OLV cases when VivaSight-DL™ was employed. The reduced use of fiberoptic bronchoscopy in the current evaluation was associated with several clinical and economic advantage by the authors. Economic analysis by one center (University Medical Center), demonstrated saving of €12 000/$16 000 for every 100 OLV cases where VivaSight-DL™ was employed.

As reported in the January, 2015 issue of the Canadian Journal of Anesthesia8, investigators at University Hospital Zurich, demonstrated that flexible fiberoptic bronchoscopy was eliminated when utilizing VivaSight™ to achieve OLV, compared with flexible fiberoptic bronchoscopy required in 85% of the cases which did not utilize VivaSight™ to achieve OLV. Recent literature suggests flexible fiberoptic bronchoscope expenses of $1009 to $28010 per OLV case. Earlier findings by investigators at the Leiden University Medical Center (Leiden, Netherlands) and Haga Hospital (The Hague, Netherlands) reported11 that VivaSight™ reduced time to achieve OLV by 22%, compared to surgical procedures utilizing flexible fiberoptic bronchoscopy. Furthermore, associated expenditures on a per surgery basis were reduced by at least 17% when using VivaSight™-DL due to the elimination of flexible fiberoptic bronchoscopy. Additionally, investigators at MD Anderson (Houston, TX) demonstrated12 in over 93% of patients evaluated that the use of flexible fiberoptic bronchoscopy was not required.

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 with a bronchoscope to maintain lung isolation.13 It is estimated that over 1.9 million lung isolation procedures are conducted worldwide annually,14 accounting for over $250 million in single-use medical disposables.15

Forward-Looking Statement

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 Dr. Jagtar Singh Heir is an Associate Professor, Department of Anesthesiology and Perioperative Medicine, Division of Anesthesiology and Critical Care, The University of Texas MD Anderson Cancer Center, Houston, TX

2 http://www.reuters.com/article/2015/02/19/us-usa-ucla-bacteria-idUSKBN0LN05J20150219

3 n engl j med 348;3

4 n engl j med 348;20 w

5 Principles and Practices of Anesthesia for Thoracic Surgery. P. Singer (ed.) 2011

6 Anaesthesia. doi:10.1111/anae.13068

7 Journal of Cardiothoracic and Vascular Anesthesia 2014; 28: 882–4

8 Can J Anesth/J Can Anesth, DOI 10.1007/s12630-015-0329-8

9 Journal of Anesthesia and Clinical Research, 3:215. doi:10.4172/2155-6148.1000215

10 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.

11 2014 European Society of Thoracic Surgeons Meeting, Copenhagen, Denmark, June 15-18, 2014

12 J Cardiothorac Vasc Anesth. 2014 Aug;28(4):882-4. doi: 10.1053/j.jvca.2013.11.011. Epub 2014 Mar 20

13 Anesthesia & Analgesia. 2009;108:1097–101

14 National Health Statistics Reports Number 29, October 26, 2010

15 Company estimates on file


Source: ETView Medical

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.