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TEMPO outcomes

Four-year TEMPO outcomes show impact on GERD of TIF procedure

Longest follow-up data classifies the TIF procedure as a durable alternative to medications and traditional anti-reflux surgery

Four-year follow-up data from TEMPO (TIF EsophyX vs Medical PPI Open Label), a prospective, randomised, multi-centre clinical study has confirmed the long-term control of chronic gastroesophageal reflux disease (GERD) symptoms after a Transoral Incisionless Fundoplication (TIF) 2.0 procedure. Dr Karim S Trad, Clinical Professor of Surgery at George Washington University School of Medicine and principal investigator presented the study data at the Minimally Invasive Surgery Week 2017, Society of Laparoendoscopic Surgeons (SLS) 2017 Annual meeting in San Francisco, CA.

Performed without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical repair an effective treatment option to correct the underlying cause of GERD. Most patients stopped using daily medications to control symptoms and had their esophageal inflammation (esophagitis) eliminated up to three years after the TIF procedure based on studies.

The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids refluxing back into the oesophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope. EndoGastric Solutions launched the third generation EsophyX device, the EsophyX Z model, in 2015. The evolving EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes to treat the underlying anatomical cause of GERD. These options include low profile and larger high-definition models.

During the study trial, sixty-three patients who suffered from chronic GERD symptoms were randomized to either undergo TIF 2.0 procedure (n=40) using the EsophyX device or take proton pump inhibitor (PPI) therapy (n=23); all remaining PPI patients (n=21) elected to cross over and receive TIF procedures six months after the start of the study.

All primary endpoints of the study were met with 89 percent of patients reporting the elimination of regurgitation and 87 percent of patients reporting elimination of all atypical symptoms at four years post-procedure.

“This new four-year analysis represents an important clinical milestone for patients who no longer benefit from PPI therapy and are seeking lasting relief from chronic GERD symptoms,” said Dr Trad. “The results of this comprehensive study confirm the endoscopic TIF 2.0 procedure as a durable alternative to PPIs and more invasive anti-reflux surgery operations.”

“The recent data from this multi-center study reaffirms the existing clinical evidence that supports the TIF 2.0 procedure as an effective long-term treatment option for patients who suffer from GERD symptoms despite the use of PPIs,” said Skip Baldino, President and CEO of EndoGastric Solutions. “Many thanks to Dr. Trad and the other investigators for their continued contributions to improve long-term patient outcomes.”

The EsophyX device with SerosaFuse fasteners and accessories are indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. They are indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy. The device is also indicated to narrow the gastroesophageal junction, and reduce hiatal hernia ≤2cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.

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