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EndoGastric Solutions Reports Extension of U.S. Clinical Evidence Supporting TIF

One Case Series Demonstrates pH Normalization in Excess of 70%

Second Case Series Reports Over 90% of Patients Completely off PPIs

Published Friday, January 8, 2010

by Chip Hennen

Redwood City, CA (January 8, 2010) – EndoGastric Solutions (EGS), the recognized leader in the emerging field of Natural Orifice Surgery (NOS), today announced that data from two single-center series demonstrate improved clinical outcomes from a third-generation technique for its Transoral Incisionless Fundoplication (TIF) procedure. The data includes two case series totaling nearly 70 patients from two independent investigators, Reginald Bell, MD (Swedish Medical Center, Englewood, CO), and William Barnes, MD (Livingston Hospital and Healthcare Services, Inc., Salem, KY)

Dr. Bell’s recorded pH Normalization and PPI dependence in 29 TIF patients at median 5 months (1-12), with key results demonstrating:

  • 76% of patients had normalized esophageal pH
  • 86% of patients were completely off PPIs

Dr. Barnes completed follow-up on 38 patients at 6 median months (6 - 12). Results showed:

  • 92% of patients were completely off PPIs
  • 87% of patients were satisfied and 82% were asymptomatic based on HRQL and GSRS scores

"The latest evolution of the TIF procedure has resulted in even better clinical outcomes than those previously reported,” said Thierry Thaure, President and Chief Executive Officer of EndoGastric Solutions. "Over the past several years, EGS has partnered with key opinion leading surgeons to advance the TIF procedure and the EsophyX device. This new data is further evidence that our technology enables a true transoral esophagogastric fundoplication procedure and results in substantial patient benefits. TIF is rapidly becoming the standard of care for chronic acid reflux sufferers.”

“Our TIF technique has evolved, and my results have continuously improved,” commented Dr. Bell. “The reported pH normalization numbers are excellent and are significantly higher than those previously reported. My TIF patients are experiencing a significant improvement in quality of life. With this experience, I firmly believe that TIF represents a safe and effective fundoplication procedure appropriate for a wide range of patients suffering from chronic acid reflux. Today, over 50% of my routine surgical reflux practice is incision free.”

About Dr. Bell’s Case Series
Dr. Bell’s retrospective case series includes a total of 37 consecutively treated patients. The data reported today includes the first 29 patients with completed pH testing. The complete results are being collected and will be submitted for publication. 

About Dr. Barnes’ Case Series
The data reported on 38 patients represents the complete initial follow-up in a retrospective study of 60 consecutive patients. The complete results are being collected and will be submitted for publication.

Advanced TIF Course information
This course was developed for both experienced and novice TIF surgeons. The course showcases the latest technical developments in transoral reflux surgery and will feature four live case demonstrations. Interested surgeons can find out more at www.advancedtifcourse.com.


 

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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