Merit Medical Receives CE Mark for Wrapsody Endovascular Stent Graft System

SOUTH JORDAN, Utah, May 26, 2020 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, today announced that it received the CE mark for the WRAPSODY Endovascular Stent Graft System from the British Standards Institution (BSI). The WRAPSODY system is a flexible self-expanding endoprosthesis indicated for use in hemodialysis patients for the treatment of stenosis or occlusion within central veins as well as the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft.

Merit has worked for almost eight years to design, develop and establish the appropriate technology and manufacturing capabilities for this product. Merit recently completed enrollment and primary follow-up of its WRAPSODY FIRST study which included 46 patients in Europe. Merit submitted an IDE (Investigational Device Exemption) application to the FDA for its review and consideration prior to the initiation of its WAVE Pivotal Study. After completion of the WAVE pivotal study, Merit intends to submit a PMA (Pre-Market Approval) application to the FDA.

“We are pleased to receive this certificate and the opportunity to offer this unique product to the European community,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “I want to thank the principal investigators of the WRAPSODY FIRST study as well as our research and development, medical affairs and regulatory affairs staff members who worked tirelessly on this project.”

Merit intends to offer additional products utilizing this technology platform, subject to additional submissions and review by the FDA and the European Union notified body.

Recently Merit received three Breakthrough Device Designations covering indications and cohorts of the IDE for the WRAPSODY system which have been filed with the FDA.

Merit intends to systematically introduce the WRAPSODY system in Europe as procedures are resumed following the ongoing lockdown due to COVID-19. Additionally, Merit also plans to initiate registration activities associated with the system in Australia, Canada and certain countries in Latin America. The WRAPSODY system is complementary to other products that Merit produces or distributes, such as the HeRO Graft, the Surfacer Inside-Out Access Catheter System and other vascular access products.