EndoChoice® Announces FDA Clearance of its Orca(TM) Sterile, Single-Use Air/Water and Suction Valves
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New Sterile, Single-Use Valves to be Presented at DDW® 2016 and the SGNA 43rd Annual Course
ALPHARETTA, Ga. - EndoChoice Holdings, Inc. (NYSE: GI) announced it received 510(k) clearance for its new Orca™ sterile, single-use air/water and suction valves for Olympus® 160, 180 and 190 Series flexible endoscopes. Recently published clinical guidelines from Association for the Advancement of Medical Instrumentation (AAMI) and the Society of Gastroenterology Nurses and Associates (SGNA), state that reusable endoscopic accessories (e.g., air/water and suction valves) should be reprocessed together and stored with a specific endoscope as a unique set to ensure traceability. By eliminating the need to clean and disinfect reusable valves, the single use Orca™ valves allow clinicians to adhere to these new guidelines while improving patient care and workflow efficiency. The company will begin sales and distribution of the new valves in the United States, European Union, and other select markets.
EndoChoice will highlight the new sterile, single-use valves at Digestive Disease Week® (DDW®) in San Diego, California (Booth #4317), and at the SGNA™ 43(rd) Annual Course in Seattle, Washington. EndoChoice will display at these meetings May 22 to 24.
Commenting on the announcement, Mark Gilreath, Founder and CEO of EndoChoice said, "EndoChoice has been dedicated to improving the standard of care for infection control since 2010, when it launched the Compliance EndoKit®, the first GI procedural kit designed to help clinicians standardize to good infection control practices. The Orca™ sterile single use air/water and suction valves are an excellent addition to the Compliance EndoKit®, thus continuing to improve the standard of care in GI."
About EndoChoice
Based near Atlanta, Georgia, EndoChoice® (NYSE: GI) is a medtech company focused on the manufacturing and commercialization of platform technologies including endoscopic imaging systems, devices and infection control products and pathology services for specialists treating a wide range of gastrointestinal conditions, including colon cancer. EndoChoice leverages its direct sales organization to serve more than 2,500 customers in the United States and works with distribution partners in 30 countries. The Company was founded in 2008 and has rapidly developed a broad and innovative product portfolio, which includes the Full Spectrum Endoscopy® (Fuse®) system. EndoChoice, Fuse, and Full Spectrum Endoscopy are registered trademarks of EndoChoice, Inc.
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Company Contact:
Ryan Moskowitz
Senior Director, Marketing Communications
EndoChoice
678-708-4403
ryan.moskowitz@endochoice.com
Source
EndoChoice
Web Site: http://www.endochoice.com
