Latest News
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.
These sites join those already included in the TIF Registry study:
“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® For more information about EndoGastric Solutions and its products, EsophyX® and StomaphyX®, please visit: http://www.endogastricsolutions.com
PRESS CONTACT: CUSTOMER CONTACT: EUROPEAN CUSTOMER CONTACT: NP02161-01A ### |
NP01366-01B



