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Multicenter TIF Registry Expanded to Nine Sites

50 Patients Enrolled in Study, 200 Anticipated by Year-End

Published Wednesday, July 28, 2010

by Chip Hennen

Redwood City, CA (July 28, 2010) – EndoGastric Solutions (EGS), the recognized leader in the emerging field of Natural Orifice Surgery (NOS), today announced that it has added three sites and four investigators to its TIF (Transoral Incisionless Fundoplication) Registry Study.

The TIF Registry Study is designed to demonstrate the safety and effectiveness of the TIF procedure for the treatment of both typical (heartburn, regurgitation) symptoms and atypical (persistent cough, laryngitis, asthma) manifestations of gastroesophageal reflux disease (GERD) in a broad range of patients in routine clinical practice. Fifty patients have been enrolled in the study, and the company anticipates enrolling at least 200 by the end of 2010.

The following new sites and investigators have begun enrolling patients. All meet or exceed established experience and proficiency requirements.

  1. Glenn Ihde, MD, Ihde Surgical Group, PS (Arlington, TX)
  2. Robert Sewell, MD, The Master Center for Minimally Invasive Surgery (Southlake, TX)
  3. Karim Trad, MD, Principal Investigator and Daniel Turgeon, MD, Co-Principle Investigator, Reston Hospital (Reston, VA)

These sites join those already included in the TIF Registry study:

  1. William Barnes, MD, Livingston Hospital and Healthcare Services (Salem, KY)
  2. Reginald Bell, MD, SurgOne PC (Englewood, CO)
  3. Tanja Gunsberger, DO, Arizona Regional Medical Center (Mesa, AZ)
  4. Kevin Hoddinott, MD, Munroe Regional Medical Center (Ocala, FL)
  5. Karl LeBlanc, MD and Mark Hausmann, MD, Surgeon’s Group of Baton Rouge, (Baton Rouge, LA)
  6. Peter Mavrelis, MD, Principal Investigator,  St. Mary’s Hospital (Hobart, IN)

 “My TIF patients are satisfied and have results comparable to more invasive fundoplication procedures,” said Dr. Glenn Ihde, a general surgeon from Dallas, TX. “I applaud EndoGastric Solutions for its approach to studying the TIF procedure in community clinical practice, as it will help generate greater understanding of, and confidence in, this new technology. This is the first step in elevating the procedure to the standard of care.”

“We are encouraged by the rate of enrollment and the early results of this Registry study,” commented Thierry Thaure, President and Chief Executive Officer of EndoGastric Solutions. “This study is an important step and provides validation of the clinical potential and therapeutic benefits of TIF and Natural Orifice Surgery (NOS) for the treatment of GERD in a diverse population of patients."

Registry Study Overview

The TIF Registry Study is a multicenter, prospective, non-randomized study with a primary outcome measure of GERD symptom elimination as evaluated using three disease specific standardized questionnaires. Secondary outcome measures include: elimination of Proton Pump Inhibitor (PPI) usage, frequency of esophageal acid exposure, and healing of reflux esophagitis. All adverse events will be reported. The authors anticipate announcing results of the first 200 patients and continuing to enroll to reach a total of at least 500 patients.


 

About EndoGastric Solutions®
EndoGastric Solutions, Inc. is a pioneer in endoluminal procedures for the treatment of upper gastrointestinal diseases, including gastroesophageal reflux disease (GERD) and other GI disorders. EGS’ mission is to utilize the most current wisdom in gastroenterology and surgery to develop new transoral procedures and products to address the largest unmet needs in gastrointestinal diseases.

For more information about EndoGastric Solutions and its products, EsophyX® and StomaphyX®, please visit:

http://www.endogastricsolutions.com

 

PRESS CONTACT:
Chip Hennen
Marketing Department
EndoGastric Solutions, Inc.
(650) 226-2236
chennen@endogastricsolutions.com

CUSTOMER CONTACT:
David Schummers
EndoGastric Solutions, Inc.
(650) 226-2233
dschummers@endogastricsolutions.com

EUROPEAN CUSTOMER CONTACT:
Adrian Lobontiu, MD
EGS Europe
+33 6 07 06 53 83
alobontiu@endogastricsolutions.com

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