FDA Breakthrough Device Designation for Wrapsody endovascular stent graft system

Wrapsody 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 [...]