Longest follow-up data from randomized controlled trial available
REDMOND, Washington – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced the presentation of three-year follow-up data from TEMPO, a prospective, randomized, multicenter clinical study. The data confirms long-term control of chronic GERD after a Transoral Incisionless Fundoplication (TIF®) procedure with the EsophyX® device. The study will be presented at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2016 Annual meeting, taking place from March 16-19, 2016 in Boston, Massachusetts.
Sixty-three patients who suffered from troublesome chronic GERD symptoms were randomized to either undergo the TIF procedure (n=40) using the EsophyX device or take proton pump inhibitor (PPI) therapy (n=23); all patients in PPI control group crossed over and received TIF procedures six months after the start of the study.
At up to 36 months follow-up, 91% of patients reported elimination of troublesome regurgitation, 70% were able to completely stop PPI therapy, and reflux esophagitis healed in 87% of patients.
“Our data demonstrates that the benefits of transoral incisionless fundoplication are sustained up to three years following the procedure. Symptom control, reduction in acid exposure, healing of esophagitis, and cessation rates of PPIs are maintained over time, proving that the TIF procedure is a durable alternative to PPIs and more invasive anti-reflux operations” said Karim Trad, MD, Clinical Professor of Surgery at George Washington University School of Medicine and Health Sciences and principal investigator, who will present the data.
The data will be presented the SS08 Flexible Endoscopy session starting at 3:30 PM to 5:30 PM on Thursday, March 17, 2016 in Ballroom A moderated by Frederick L. Greene, MD and G. V. Rao, MS, MAMS.
EGS will also provide demonstrations of the EsophyX device for the TIF procedure at booth #416 in the SAGES exhibit hall from March 16-18.
“The ongoing, excellent results from this multi-center study represent another clinical milestone and add to the existing strong body of clinical evidence that support the TIF procedure as an excellent treatment option for patients who no longer benefit from PPIs and are seeking long-term relief from ongoing GERD symptoms,” said Skip Baldino, President and CEO of EndoGastric Solutions. “Our thanks to Dr. Trad and the other investigators for their ongoing commitment to providing the GERD patients they serve with a full armamentarium of treatment options.”
In 2015 SAGES, in cooperation with the three primary GI societies—AGA, ACG, ASGE, jointly sponsored an application to the American Medical Association for a new Category I Current Procedural Terminology (CPT®) code. CPT 43210: EGD esophagogastric fundoplasty became effective January 1, 2016.
About Current Procedural Terminology (CPT®)
CPT codes are a listing of descriptive terms and identifying codes for reporting medical services and procedures. The purpose of CPT is to provide a uniform language that accurately describes medical, surgical, and diagnostic services, and thereby serves as an effective means for reliable nationwide communication among physicians and other healthcare providers, patients, and third parties. CPT® is registered trademark of the American Medical Association.
The Federal Register has posted coding and payment information specific to the new CPT code, allowing patients to more easily receive access to treatment for GERD. Physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty and APC 5331 Complex GI Procedures for TIF procedures as of January 1, 2016.
NP02450-01A/-02A
