April 6, 2020
Merit Medical Receives Two Breakthrough Device Designations for the Wrapsody Stent Graft System
April 6, 2020—Merit Medical Systems, Inc announced that it has been granted two additional FDA Breakthrough Device designations for its Wrapsody endovascular stent graft system. The Wrapsody system is a flexible, self-expanding endoprosthesis.
The new indications for use that the company is seeking FDA approval for include treatment of stenosis or occlusion within the dialysis outflow circuit, including stenosis or occlusion (1) within the peripheral veins in the arm of arteriovenous fistula patients, and (2) within the thoracic central veins (up to the superior vena cava) in arteriovenous graft patients.
Merit believes approval for the expanded indications will increase patient access to this life-saving technology. The Wrapsody system is not currently available for sale, advised the company.
The FDA Breakthrough Devices 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.