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2013

August 2013
Study Results from Department of Anesthesiology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands, Published in Pediatric Anesthesia in August 2013

A study conducted by Radboud University Nijmegen Medical Center by Luc K. P. Tielens MD et. al. was published in the August 2013 issue of pediatric Anaesthesia. In this study, a retrospective review was carried out for all pediatric patients, in which the Episure™ Autodetect™ syringe was used for locating the epidural space between 2007 and 2011. In 17 pediatric patients (9 months -14 years, 7,5 -43 Kg weight), the EpisureTM syringe was used. In all 17 patients, the epidural space was identified using the spring-loaded syringe as evidenced by satisfactory analgesia. No accidental dural punctures or false loss-of-resistances were observed.

January 2013
Study Results from the Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA Published in Anesthesia & analgesia in January 2013 Issue

A study conducted by Brigham and Women’s Hospital by Jean M. Carabuena MD, et. al. where Episure™ Autodetect™ (Spring-loaded) syringe has been observed to successfully identify the epidural space in 2 pilot studies. In this study the impact of the spring-loaded syringe on the establishment of successful epidural labor analgesia(primary outcome), and elapsed time for catheter placement, and learning curve (cumulative summary analysis, i.e. Cusum) of experienced anesthesiologists. When used by experienced obstetric anesthesiologists, the spring- loaded syringe was associated with a similar overall rate for establishing successful epidural labor analgesia, a shorter elapsed time to epidural catheter insertion, particularly when the anesthesiologist was randomized to use the novel syringe first, and a similar Cusum curve when compared with a conventional glass syringe. Attending versus fellow anesthesiologists and an initial technique preference for loss- of- resistance to continuous saline were associated with greater analgesia success with the novel syringe.


2008

February 1, 2008
Study Results from Duke University Medical Center Published in Anesthesia & Analgesia In February 2008 Issue
  Durham, NC
A study conducted by Duke University Medical Center at Durham, North Carolina by Ashraf Habib, MBBCh, MSc, FRCA, et. al., was published in the February 2008 issue of Anesthesia & Analgesia. In this pilot study, the Episure syringe was compared with the standard glass syringe for identification of the epidural space during initiation of epidural analgesia in parturients. The primary outcome was the incidence of failed epidural analgesia. Three-hundred and twenty-five women were enrolled. Eight residents performed 291 procedures (90%) and two attendings performed 34 procedures (10%). Epidural analgesia failed in five subjects in the glass syringe group and in no subject in the Episure syringe group (P = 0.025).


2007

October 9, 2007
Study Results from Stanford University Published in Anesthesia & Analgesia In October 2007 Issue
  Stanford, California
A study conducted by Lucile Packard Children’s Hospital and Stanford University School of Medicine at Stanford, California by Brendan Carvalho, MBBCh, FRCA and Edward Riley, MD, was published in the October 2007 issue of Anesthesia & Analgesia. Thirty laboring patients participated in this study and no accidental dural punctures of false LORs were encountered. The study showed that the Episure may assist attending physicians in supervising residents doing an essentially “blind,” subjective epidural procedure. In conclusion, the Episure provided a unique and potentially useful tool for detecting Tuohy needle placement in the epidural space.

May 17, 2007
Study Results from Duke University Presented at the 39th Annual SOAP Conference
  Alberta, Canada
2006 study conducted by Duke University Medical Center in Durham, North Carolina, utilizing the Episure AutoDetect Loss of Resistance Syringe, presented at the 39th Annual SOAP conference.

May 17, 2007
Study Results from Huzel Women’s Hospital at Wayne State University Presented at the 39th Annual SOAP Conference
  Alberta, Canada
2006 study conducted by Huzel Women’s Hospital at Wayne State University in Detroit, Michigan, utilizing the Episure AutoDetect Loss of Resistance Syringe, presented at the 39th Annual SOAP conference.

April 11, 2007
Episure AutoDetect Syringe Wins Medical Design Excellence Award (MDEA)
  Irvine, California
Indigo Orb, Inc. today announced that their Episure AutoDetect has received a 2007 Medical Design Excellence Award. The Episure AutoDetect is a spring-loaded, automatic loss of resistance (LOR) syringe used in epidural anesthesia.

February 13, 2007
Indigo Orb, Inc. Launches Episure™ AutoDetect™ Loss of Resistance Syringe in the U.S.
  Irvine, California
Indigo Orb, Inc., a leading medical device manufacturer, announces the U.S. launch of their Episure™ AutoDetect™ Loss of Resistance syringe. While the Episure AutoDetect syringe has been in distribution within Europe since 2005, January 2007 marks the full-scale launch in the U.S.

January 29, 2007
Episure AutoDetect Syringe
  Medgadget.com
Indigo Orb, Inc., from Orange County, CA, is expecting to change the way we (anesthesiologists, including your correspondent) do this procedure. Filled with normal saline, the company’s Episure AutoDetect syringe has a plunger that automatically loses resistance, which “provides an objective, visual confirmation that the Epidural Space has been identified.”


2006

Multi-Center Clinical Evaluations in Progress  Irvine, California
Studies are currently in progress at the following institutions; Brigham & Women’s Hospital in Boston, MA, Duke University Medical Center in Durham, NC, Huzel Women’s Hospital at Wayne State University in Detroit, MI, and at Stanford University Medical Center in Palo Alto, CA. Peer review journals and abstracts will be available in 2007.


2005

October 25, 2005
Study Results from Stanford University Medical Center Presented at the Annual ASA Conference
  Atlanta, Georgia
2005 study conducted by Stanford University Medical Center in Stanford, CA, utilizing the Episure AutoDetect Loss of Resistance Syringe, presented at the 2005 Annual ASA conference.


2004

November 2004
Initial Testing of Episure AutoDetect Syringe Results
  Stanford, California
A 2004 study conducted by Stanford University Medical Center in Stanford, CA by Edward Riley, M.D. and Brendan Carvalho, M.D., utilizing the Episure AutoDetect syringe shows successful results.

June 23, 2004
FDA Grants Clearance
  Rockville, Maryland
The Food and Drug Administration grants clearance of Episure AutoDetect syringe.