Merit Medical has been granted Breakthrough Device Designation by the FDA for the Wrapsody endovascular stent graft system. A press release reports that 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 up to the superior vena cava.
The Wrapsody system, the press release states, is nearing completion of its first-in-human studies and is not currently available for sale. Fred P Lampropoulos, Merit Medical’s Chairman and CEO, comments: “We are pleased with the recognition by the FDA of this worthwhile technology as well as the efforts of many members of our R&D team to bring the project to this point. Most importantly, we believe this system will provide substantial benefits to patients who may be treated with it in the future.”
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.