EGS announces presentation of TIF2 procedure clinical results at SAGES meeting

Apr 30 2010

EndoGastric Solutions (EGS) today announced that new U.S. clinical results for their third generation Transoral Incisionless Fundoplication (TIF2) procedure were presented during the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) meeting April 14-17, in Washington, DC. Clinical outcomes data for over 100 patients treated with the TIF2 procedure were presented by Kevin Hoddinott, MD (Munroe Regional Medical Center, Ocala, FL), and William Barnes, MD (Livingston Hospital and Healthcare Services, Inc., Salem, KY).

“The benefits of the incisionless TIF procedure go beyond just eliminating skin incisions”

Dr. Hoddinott presented Transoral Incisionless Fundoplication is Effective for Treatment of Chronic GERD Patients with Therapy Resistant Symptoms, a 9-median-month (5-13) follow-up on 43 consecutive patients. Results showed:

• 88% of patients off daily PPIs
• 80% of patients experienced total elimination of heartburn and reflux
• 77% of patients were satisfied
• 100% of hiatal hernias were reduced
• 100% of patients showed esophagitis healed or reduced
  • 68% esophagitis healed
  • 32% reduced

Dr. Barnes presented Transoral Incisionless Fundoplication Improves Reflux Symptoms in Long-time PPI Users: Clinical Outcomes of a Community Based Retrospective Study in Livingston County Kentucky, documenting the largest TIF2 patient series to date, 60 consecutive patients at 6 median months (5 - 14). Results showed:

• 97% of patients were completely off PPIs
• 90% of patients were satisfied
• Of 25 patients who had a follow-up endoscopy
  • 100% had a reduction in hiatal hernia
  • 100% had healed esophagitis

"Our institution has performed over 150 TIF procedures in a broad spectrum of patients," commented Dr. Hoddinott. "It has been my experience that the TIF antireflux valves work, and we are very satisfied with the outcomes we have been able to achieve."

"The benefits of the incisionless TIF procedure go beyond just eliminating skin incisions," Dr. Barnes explained. "TIF avoids vascular and ligament dissections required by laparoscopic fundoplication procedures. This hastens recovery and is likely to offer other long-term patient benefits as well."

"It is evident that TIF2 provides reproducibly excellent results for patients with early-to-moderate stage GERD who cannot be adequately managed medically," Dr. Barnes continued. "At 6 months after the procedure, 97% of my patients are completely off PPIs and are experiencing a much improved quality of life. In terms of patient safety and welfare, I believe that TIF will become the standard of care for this appropriately selected patient population."

"It is becoming apparent that TIF is a very safe procedure," explained W. Scott Melvin, MD (Professor of Surgery, Chief, Division of General & Gastrointestinal Surgery, The Ohio State University, Columbus, OH). "In the 200 patients presented at SAGES (including the U.S. TIF2 clinical outcomes data, three other posters and multiple presentations) the TIF safety data compared favorably with other more invasive fundoplication procedures. Of the 200 procedures reported at the meeting, there were only four incidences of complications with just one patient requiring subsequent intervention. This is consistent with the overall TIF clinical experience, which to date has demonstrated no mortalities, no long-term complications, and only a 0.6% complication rate in over 2,000 TIF procedures."

"The effectiveness and particularly the safety profile for TIF allow it to be a beneficial procedure in the full range of hospitals from small critical access hospitals like Livingston to larger community hospitals like Munroe and very large hospitals and academic centers," commented Thierry Thaure, President and Chief Executive Officer of EndoGastric Solutions. "This new U.S. TIF2 data builds upon our growing foundation of clinical data and continues to validate the role for TIF in managing gastroesophageal reflux disease (GERD). Natural Orifice Surgery (NOS), led by the TIF procedure, is the future. Now, with over 4,000 NOS procedures and over 2,000 TIF procedures performed worldwide, it is becoming evident that NOS and TIF are also the present."

SOURCE EndoGastric Solutions, Inc.

http://www.endogastricsolutions.com