FDA Grants Breakthrough Device Designation for Merit Medical’s Wrapsody Endovascular Stent Graft
November 21, 2019—Merit Medical Systems, Inc. announced that it has been granted Breakthrough Device designation by the FDA for the company's Wrapsody endovascular stent graft system. The Wrapsody system is a flexible, self-expanding endoprosthesis.
As noted in the company’s announcement, Merit intends to seek an indication for use in hemodialysis 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 Wrapsody system is nearing completion of its first-in-human studies and is not currently available for sale.
The FDA Breakthrough Device program 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 program, the FDA provides priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions, advised Merit Medical Systems.