EGS publishes three clinical studies on TIF procedure over past four months

EndoGastric SolutionsFeb 18 2011

EndoGastric Solutions (EGS), the leader in the emerging field of Natural Orifice Surgery (NOS), announced that three clinical studies on transoral fundoplication have been published over the past four months. The addition of over 185 patients to the literature substantially increases the evidence supporting the safety and effectiveness of the Transoral Incisionless Fundoplication (TIF) procedure for the surgical treatment of gastroesophageal reflux disease (GERD).

Taken together, these publications demonstrate:

• Excellent therapeutic response rate in patients with both typical and atypical symptoms of GERD (79-97% off daily PPI medications)
• Significant response to objective measurements of reflux (89% normalization of reflux episodes)
• Low complications rate (aggregate 2%)
• No adverse effects of dysphagia and bloating common to laparoscopic fundoplication surgery

The most recent study, by William Barnes, MD (Livingston Hospital and Healthcare Services, Inc., Salem, KY) and Kevin Hoddinott, MD (Munroe Regional Medical Center, Ocala, FL), was published February 8th in the online edition of Surgical Innovation and is being published in the print edition. This study is the largest TIF study published to date and includes 124 patients treated with TIF (110 followed for a median 7 months). Results showed that:

• 75-80% of patients recorded normalized symptom scores for both typical and atypical symptoms of reflux
• 97% of patients were off daily PPI medications
• 83% of patients were satisfied with their health condition post-TIF, compared to 3% before their procedure

Drs. Barnes and Hoddinott commented, "Less than 10% of our patients had persistent heartburn requiring medical therapy. This level compares favorably to 32% reported in a community-based study with laparoscopic Nissen." They added, "The absence of complications and low reoperation rate of 4% were below the published values for laparoscopic fundoplication."

"These new clinical findings establish that TIF can produce excellent and reproducible outcomes in a broad spectrum of surgical practice scenarios, including large academic centers and both large and small community hospitals," commented Thierry Thaure, President and Chief Executive Officer of EndoGastric Solutions. "This most recent study represents the largest transoral fundoplication patient series to date and shows that TIF can be safe and provide exceptional results both during the surgeon's learning curve and after they have mastered the technique. This data is very encouraging."

Surgical Endoscopy published in its December 2010 edition an article by Reginald Bell, MD (Swedish Medical Center and SurgOne PC, Englewood, CO), with a 6-month median follow-up of 37 TIF patients. The study demonstrated significantly improved symptomatic and objective outcomes in over 70% of patients.

• Significant improvement was seen in both typical (heartburn and regurgitation) and atypical (extraesophageal symptoms) of reflux in 64% and 70-80% of patients, respectively.
• 82% of patients remained off their reflux medications.
• Average number of reflux episodes over a 24-our period was normalized in 89% of patients. Acid exposure was significantly improved and normalized in 61% of patients.

"Our results are significant in terms of symptom improvement and objective reflux control," commented Dr. Bell. "Perhaps just as important, we have not observed any of the side effects seen with traditional fundoplications. Transoral esophagogastric fundoplication has a role in the treatment of GERD," he concluded.

In October 2010, a 26-patient study was published in Surgery by Vic Velanovich, MD (Henry Ford Hospital, Detroit, MI). The study found that 79% of patients 6-8 weeks after their TIF procedure were off their reflux medications and were satisfied with their symptom relief.

"The body of clinical evidence supporting both the safety and the efficacy of TIF is growing," said Mr. Thaure. "These three new published studies build upon our growing foundation of clinical data and continue to validate that TIF is rapidly becoming the standard of care for appropriately selected patients that are candidates for surgical fundoplication."