GREENWICH, Conn.―Mederi Therapeutics Inc. this week announced the results of a double-blind, sham-controlled study of Stretta for treatment of gastroesophageal reflux disease (GERD). The study evaluated the specific mechanism of action in the application of radiofrequency (RF) energy. This research suggests that Stretta Therapy causes a decrease in transient lower esophageal sphincter (LES) relaxations and an increase in gastric yield pressure, and therefore reduces reflux. And, as a result, improves symptoms in patients with medically refractory GERD, according to Mederi. The study results were published in the American Journal of Gastroenterology.
"In this double-blind, sham-controlled study, our data confirms that Stretta improves the physiology of the lower esophageal sphincter, and that this is the likely mechanism for symptom improvement in GERD," said Jan Tack, MD, PhD, one of the study's authors and Head of Clinic in the Department of Gastroenterology in the Center for Gastroenterological Research at the University of Leuven in Leuven, Belgium. "In addition to the noted effectiveness of the Stretta treatment, we believe that the method we employed in the study was able to exclude fibrosis as the underlying cause of the observed significant decrease in GEJ compliance."
"Professor Tack and his colleagues have helped us all take a major step forward to further explain and clarify this mechanism for Stretta, said Dr. Mark D. Noar, director at the Heartburn and Reflux Study Center, Towson, MD. "These findings on the mechanism of action explain the results both medical professionals and their patients, with medically refractory GERD, have come to expect from Stretta."
"These results add to the significant body of research on Stretta. The treatment works exceptionally well to reduce or eliminate symptoms in sufferers of GERD, but exactly how it works is now more clearly understood," said Will Rutan, CEO of Mederi Therapeutics, manufacturer of Stretta. "With 67 publications supporting Stretta as a safe, effective, and durable treatment, Stretta offers an excellent alternative to invasive surgery."
Stretta Therapy is a minimally invasive option for patients who do not respond well to medical management. Stretta involves delivery of radiofrequency energy to the LES and gastric cardia, which has been shown in numerous clinical studies to be a safe, effective, and durable therapeutic option. Stretta does not preclude next steps with more invasive procedures when indicated.