Merit Medical’s Wrapsody Gets Breakthrough Device Designation

The FDA granted Merit Medical a breakthrough device designation for its Wrapsody endovascular stent graft system.

The system is a flexible, self-expanding endoprosthesis for the treatment of blood flow restrictions in hemodialysis patients. The system is nearing completion of its first in human studies.

Merit intends to seek an indication for use within the central veins of the outflow circuit of an arteriovenous fistula up to the superior vena cava.