Merit Medical has received CE mark approval for the Wrapsody endovascular stent graft system from the British Standards Institution. The Wrapsody system is a flexible self-expanding endoprosthesis indicated for use in haemodialysis 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.
According to the company, it will introduce the Wrapsody system in Europe as procedures are resumed following the ongoing lockdown due to COVID-19. Additionally, Merit Medical plans to initiate registration activities associated with the system in Australia, Canada, and certain countries in Latin America. The company recently completed enrolment and primary follow-up of its WRAPSODY FIRST study that included 46 patients in Europe.
Moreover, Merit Medical submitted an application for an investigational device exemption (IDE) to the US Food and Drug Administration (FDA) for its review and consideration before the initiation of its WAVE pivotal study. After completion of the WAVE pivotal study, Merit Medical intends to submit a premarket approval application to the FDA, a press release states.
The company intends to offer additional products using this technology platform, subject to additional submissions and review by the US FDA and the European Union notified body. Merit Medical recently received three US FDA breakthrough device designations covering indications and cohorts of the IDE for the Wrapsody system, which have been filed with the US FDA.