Estimated read time: 4-5 minutes
This archived news story is available only for your personal, non-commercial use. Information in the story may be outdated or superseded by additional information. Reading or replaying the story in its archived form does not constitute a republication of the story.
[STK]
[IN] HEA MTC
[SU] SVY
TO HEALTH, MEDICAL, AND NATIONAL EDITORS:
American Gastroenterological Association and EndoGastric Solutions
Establish Registry for GERD Procedures
BETHESDA, Md., March, 20, 2014 /PRNewswire-USNewswire/ -- The American
Gastroenterological Association (AGA) Center for GI Innovation and
Technology today announced a partnership with EndoGastric Solutions@
to develop a registry comparing surgery to an incisionless procedure
to treat gastroesophageal reflux disease (GERD).
The "STAR Registry" (Laparoscopic Nissen Fundoplication (LNF) Surgery
Versus Transoral Incisionless Fundoplication (TIF@): Anti- Reflux
Treatment Registry) will provide the first real-world data observing
patient outcomes following traditional laparoscopic surgery and TIF
with the EsophyX@ device.
"Through the STAR Registry, the AGA will bring important data to the
conversation about the benefits of surgery in patients with GERD, a
condition that affects millions of people," said M. Brian Fennerty,
MD, AGAF, professor of medicine at Oregon Health Sciences University
and principal investigator for the STAR Registry. "This collaboration
sets an important precedence for industry and professional societies
to work together toward common goals. We will provide physicians,
patients, purchasers and payors with additional long-term efficacy
data about patients who choose surgical therapy for GERD, which is
invaluable to patient care decisions."
As a neutral objective broker, the AGA Center for GI Innovation and
Technology works with device, diagnostic and other life science
companies in the GI space to identify and gather the data needed by
key stakeholders in the health-care system. These stakeholders include
providers, payors, purchasers, accountable care organizations and
regulatory agencies. It is the goal of the AGA and the center to
identify and help assess the value of new technologies on patient care
and support approval, coverage and adoption of technologies that
demonstrate promise and merit.
"GERD is a deceptively complex condition and the most commonly used
treatment options may not adequately serve all patients. By collecting
data on transoral incisionless vs. laparoscopic fundoplication in a
well-designed observational registry, we are able to introduce
FDA-cleared innovations to a larger audience, while continuing to
evaluate safety, efficacy and comparative outcomes," said Adrian
Lobontiu, MD, FACS, medical director, EndoGastric Solutions.
"Every year, tens of thousands of patients with GERD seek consultation
about surgical options," said W. Scott Melvin, MD, FACS, vice-chairman
and chief of the division of general surgery, Montefiore Medical
Center; professor of surgery, Albert Einstein College of Medicine of
Yeshiva University; and co-principal investigator for the STAR
Registry. "Over the last decade, several technologies that could have
improved care for patients with digestive disorders have been limited
in application, or eliminated from clinical practice, due to lack of
guidance on how to capture and present data demonstrating an
improvement in health outcomes."
"EndoGastric Solutions is very enthusiastic about the opportunity to
work with the AGA and other stakeholders who have a vested interest in
digestive disease. We believe that specialty societies and industry
can work together to collect data that inform stakeholders about the
effectiveness and durability of medical technology, demonstrate
cost-efficiency and value to our health-care system, and ultimately
introduce innovation to the health-care market place in a meaningful
way," said Josh DeFonzo, vice president, EndoGastric Solutions.
The AGA Center for GI Innovation and Technology does not endorse any
product or service, develop guidelines, nor make any guarantees about
FDA approval or coverage from public or private payors.
About the AGA The American Gastroenterological Association is the
trusted voice of the GI community. Founded in 1897, the AGA has grown
to include 17,000 members from around the globe who are involved in
all aspects of the science, practice and advancement of
gastroenterology. The AGA Institute administers the practice, research
and educational programs of the organization. www.gastro.org
The AGA Center for GI Innovation and Technology supports innovation
and the development of new technology in gastroenterology, hepatology,
nutrition and obesity by guiding medical device and therapeutics
innovators through the technology development and adoption process.
www.gastro.org/CGIT
Follow us on Twitter @AmerGastroAssn | Become an AGA fan on
Facebook | Join AGA on LinkedIn |
About EndoGastric Solutions@ EndoGastric Solutions, Inc.
(www.endogastricsolutions.com), headquartered in San Mateo,
California, is a leader in the endoluminal treatment of digestive
diseases. EGS' mission is to combine the most advanced concepts in
gastroenterology and surgery to develop products and procedures that
address unmet needs in gastrointestinal diseases.
About EsophyX@ and Transoral Incisionless Fundoplication (TIF@) The
EsophyX device was FDA cleared in 2007, and is commercially available
in the United States. Inserted transorally with visual guidance from
an endoscope, the EsophyX device is used in the TIF procedure to
reconstruct the gastroesophageal valve (GEV), restoring its competency
and reestablishing the barrier to reflux. The TIF procedure is a
surgical solution that corrects the root cause of Gastroesophageal
Reflux Disease (GERD). The TIF procedure is based on traditional
surgical principles and offers similar effectiveness to a surgical
repair with the safety profile of an incision-free approach. To date,
more than 15,000 patients have been treated worldwide. For more
information, visit www.GERDHelp.com.
SOURCE American Gastroenterological Association
-0- 03/20/2014
/CONTACT: Aimee Frank, media@gastro.org, 301-941-2620
/Web Site: http://www.gastro.org
CO: American Gastroenterological Association
ST: Maryland
IN: HEA MTC
SU: SVY
PRN
-- DC87553 --
0000 03/20/2014 16:30:00 EDT http://www.prnewswire.com
Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
