Data Show Over 80% of Patients Report Ongoing Improvement or Complete Elimination of GERD Symptoms Two Years after Transoral Incisionless Fundoplication (TIF®)

Long-Term Outcomes from TIF US Registry Presented at 2013 SAGES Annual Meeting

SAGES 2013

REDWOOD CITY, Calif.--()--EndoGastric Solutions® (EGS), the leader in endoluminal reconstructive treatment for Gastroesophageal Reflux Disease (GERD), today announced the presentation of two-year data from the Transoral Incisionless Fundoplication (TIF®) US Registry at the 2013 SAGES Annual Meeting during the therapeutic endoscopy scientific session in Baltimore, Maryland.

The TIF procedure was safe and effective in eliminating or improving a range of typical and atypical GERD symptoms, including heartburn and reflux, in up to 81% of patients in the study. Also, in 81% of patients undergoing endoscopy 24 months after their TIF procedure, esophagitis was fully healed or notably improved.

“This two-year data demonstrates the long-term value of a transoral anatomic correction in the treatment of GERD patients with mild to moderate disease. We are very encouraged by the sustained response seen by patients with either typical or atypical symptoms,” said Mike Kleine, President and CEO of EGS.

Twenty-four months after the EsophyX2® device was used in TIF procedures, more than two-thirds of patients completely eliminated the need for daily proton pump inhibitor (PPIs) therapy. Symptom control achieved at six months remained stable over time, indicating durability of the TIF procedure.

“The TIF procedure is an attractive option because it dramatically shifts the risk-benefit ratio associated with correcting the underlying anatomical defect and allows a majority of patients to stop taking daily medication for reflux,” said Karim Trad, MD, FACS, SAGES presenter and an investigator in this prospective multicenter registry of patients with chronic GERD.

The risks associated with medical management of GERD patients for years or decades are becoming more evident. Traditional surgical interventions for GERD have historically been reserved for patients with the most severe disease. However, most patients have been unwilling to accept the well-documented side effects of difficulty swallowing and gas bloat associated with traditional surgery. In stark contrast, the TIF procedure offers an alternative option to select GERD patients because almost none of these side effects occurred in the TIF registry population.

The TIF procedure was also highlighted during these SAGES sessions:

  • Reginald Bell, M.D., of Swedish Medical Center, presented “Emerging Technologies and Techniques” during the Postgraduate Course Foregut Beyond GERD and Hiatal Hernia Wednesday, April 17
  • Erik Wilson, M.D., of Memorial Hermann Healthcare, presented “Transoral Incisionless Fundoplication (TIF), is the procedure here to stay?” during the Postgraduate Course Endoluminal Treatments – GERD and POEM Thursday, April 18

About EsophyX® and Transoral Incisionless Fundoplication (TIF®)

The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted transorally with visual guidance from an endoscope, the EsophyX device is used in the TIF procedure to reconstruct the gastroesophageal valve (GEV), restoring its competency and reestablishing the barrier to reflux. TIF is a surgical solution that corrects the root cause of Gastroesophageal Reflux Disease (GERD)—a disease that affects over 60 million people in the U.S. The TIF procedure is based on traditional surgical principles, is minimally invasive and offers similar effectiveness to a surgical repair with the safety profile of a transoral approach. To date, more than 10,000 patients have been treated worldwide. For more information, visit www.GERDHelp.com.

About EndoGastric Solutions®

EndoGastric Solutions, Inc. (www.endogastricsolutions.com), headquartered in Redwood City, California, is a leader in the endoluminal treatment of digestive diseases. EGS' mission is to utilize the most current wisdom in gastroenterology and surgery to develop procedures and products that address unmet needs in gastrointestinal diseases.

Contacts

EndoGastric Solutions, Inc.
Josh DeFonzo, 650-220-2220
jdefonzo[at]endogastricsolutions[dot]com
or
Lazar Partners, LTD
Hollister Hovey, 646-871-8482 (direct)
hhovey[at]lazarpartners[dot]com

Release Summary

Data Show Over 80% of Patients Report Ongoing Improvement or Complete Elimination of GERD Symptoms Two Years after Transoral Incisionless Fundoplication (TIF®)

Contacts

EndoGastric Solutions, Inc.
Josh DeFonzo, 650-220-2220
jdefonzo[at]endogastricsolutions[dot]com
or
Lazar Partners, LTD
Hollister Hovey, 646-871-8482 (direct)
hhovey[at]lazarpartners[dot]com