Merit claims to have worked for approximately eight years to design, develop and establish the suitable technology and manufacturing capabilities for the product
Merit Medical Systems has received the CE mark approval for its WRAPSODY endovascular stent graft system from the British Standards Institution (BSI).
The WRAPSODY system is a flexible self-expanding endoprosthesis designed to treat stenosis or occlusion within central veins as well as the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft in hemodialysis patients.
The company said that it has worked for approximately eight years to design, develop and establish the suitable technology and manufacturing capabilities for this product.
Merit is engaged in manufacturing and marketing of disposable devices for use in interventional, diagnostic and therapeutic procedures, in the areas of cardiology, radiology, oncology, critical care and endoscopy.
Merit chairman and chief executive officer Fred P Lampropoulos said: “We are pleased to receive this certificate and the opportunity to offer this unique product to the European community. 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.”
WRAPSODY system complements other products produced and distributed by Merit
The company has recently completed the enrolment and primary follow-up of its WRAPSODY FIRST clinical study in Europe, which included 46 patients.
In addition, the company has filed an Investigational Device Exemption (IDE) application with the FDA for its review and consideration prior to the initiation of its WAVE Pivotal Study, and intends to seek a pre-market approval (PMA) from the FDA, after completing the WAVE pivotal study.
Merit said that its WRAPSODY system complements its other products including HeRO Graft, the Surfacer Inside-Out Access Catheter System and other vascular access products.
The company has recently secured three breakthrough device designations covering indications and cohorts of the IDE for the WRAPSODY system which have been filed with the FDA.
Merit plans to systematically introduce the WRAPSODY system in Europe as procedures are resumed following the ongoing lockdown due to COVID-19.
The company also intends to begin registration activities for the system in Australia, Canada and certain countries in Latin America.