Indigo Orb, Inc., a leading medical device manufacturer, announces the U.S. launch of their Episure(TM) AutoDetect(TM) Loss of Resistance syringe. While the Episure(TM) AutoDetect(TM) syringe has been in distribution within Europe since 2005, January 2007 marks the full-scale launch in the U.S.
The Episure(TM) AutoDetect(TM) is a spring-loaded, automatic Loss of Resistance (LOR) syringe used in epidural anesthesia. This involves administering medications directly into the epidural space which numbs patients from chest to legs. Traditionally, this procedure is performed using a standard LOR syringe which requires the practitioner to rely on thumb pressure to feel for change in resistance while advancing the needle into the epidural space. The Episure(TM) syringe utilizes a specially engineered internal compression spring which applies precise and constant force on the plunger that automatically depresses when the epidural needle enters the epidural space, eliminating the subjective "feel" required with standard LOR syringes. In addition to providing a visual confirmation, Episure(TM) allows the practitioner to continuously advance the epidural needle with both hands resulting in superior control and sensitivity. Edward Riley, M.D., Director of Obstetric Anesthesia at Stanford University School of Medicine said, "I believe this could become a valuable tool to help anesthesiologists find the epidural space more consistently."
Clinical studies at Stanford University revealed all epidurals placed using the Episure(TM) syringe delivered successful analgesia, and there were no dural punctures or other complications. This study was published as an abstract at the American Society of Anesthesiologists in December 2005. Multi-center clinical studies are currently being conducted at Brigham & Women's Hospital, Duke University, Wayne State University and Stanford University and will be available for publication in May 2007.
A recent study conducted by Vitaly Soskin, M.D. at Wayne State University in Michigan, showed that the Episure(TM) syringe helps more accurately and objectively identify the epidural space, providing better stability and controlled movement. The participants believe that the Episure(TM) syringe "is a good learning tool, especially for anesthesia residents and could be a very useful addition to the Anesthesia Department." Additionally, the participating physicians found an advantage of using two hands during epidural placement with the Episure(TM) syringe.
Ashraf Habib, M.D., Assistant Professor at Duke University Medical Center in North Carolina, said that the Episure(TM) syringe will likely reduce inadvertent dural punctures that cause severe headaches and bed rest if the epidural needle is incorrectly placed. "The Episure(TM) allows performing the constant pressure technique while maintaining excellent control of the epidural needle. I believe that you could demonstrate that one could perform the procedure quicker and you might have a lower incidence of inadvertent dural punctures, and it is a safer technique. I believe that practitioners with different levels of experience can benefit from using the Episure(TM) syringes."
Karl Im, Chief Executive Officer of Indigo Orb said that the Episure(TM) syringe is similar enough to existing LOR syringes that it can be substituted into the current procedure without changing the paradigm of the epidural process.
The Episure(TM) AutoDetect(TM) syringe is FDA cleared and 510K CE marked. It is available in single units and in continuous epidural trays.
About Indigo Orb, Inc.
Indigo Orb, Inc. is a manufacturer of innovative medical devices to enhance and improve patient care while meeting the decision making needs of healthcare professionals without changing the paradigm of the procedures. Based in Irvine, CA, Indigo Orb is committed to providing cutting-edge solutions to create long-term value in the healthcare industry. For more information, please visit http://www.indigo-orb.com.
Indigo Orb, Inc.
http://www.indigo-orb.com
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