Merit Medical Systems has announced that it has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for the Merit Wrapsody endovascular stent graft system. The Wrapsody system is a flexible, self-expanding endoprosthesis for which Merit intends to seek indication for use in haemodialysis patients for the treatment of stenosis within the central veins of the outflow circuit of an arteriovenous fistula (AVF) up to the superior vena cava.
The FDA breakthrough devices programme is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the programme, the FDA provides priority review and interactive communication regarding device development and clinical trial protocols, through to commercialisation decisions. The Wrapsody system is nearing completion of its “first-in-man” studies, and is not currently available for sale.
“We are pleased with the recognition by the FDA of this worthwhile technology as well as the efforts of many members of our research and development team to bring the project to this point,” says Fred P Lampropoulos, Merit Medical’s chair and CEO. “Most importantly, we believe this system will provide substantial benefits to patients who may be treated with it in the future.”