Merit Medical Completes Enrollment in EVOLVE Study

Merit Medical Systems Inc., a manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, has completed enrollment in its EVOLVE study. 

The EVOLVE study is a prospective, multicenter, single-blind, randomized, U.S. Food and Drug Administration IDA-approved phase 3 study comparing Merit’s EndoMAXX EVT fully-covered esophageal stent with valve to the EndoMAXX fully-covered esophageal stent for malignant strictures requiring stent placement across the gastroesophageal junction. Sixty patients with strictures of the esophagus at the junction to the stomach due to cancer have been enrolled at seven sites. 

The study is investigating whether the valve in the EndoMAXX EVT stent can facilitate swallowing by treating the esophageal stricture while also limiting reflux.
 
“The prevalence of esophageal malignancy is increasing, and we are pleased that our study is closer to completion,” said Fred P. Lampropoulos, Merit’s chairman and CEO. “We are hopeful that this product can improve the quality of life for suffering patients.”
 
The EndoMAXX EVT stent has a tricuspid valve designed to simulate the natural valve at the gastroesophageal junction, the only esophageal stent of its kind. It has been CE marked in the European Union since September 2013. 
 
Founded in 1987, Merit Medical Systems develops, manufactures and distributes proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy.  Merit employs approximately 4,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Va.; Malvern, Pa.; Rockland, Mass.; San Jose, Calif.; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada, and Melbourne, Australia.