Merit medical systems, inc. receives fda breakthrough device designation for wrapsody™ endovascular stent graft system

Merit medical systems, inc. announced that it has been granted breakthrough device designation by the u.s. food and drug administration (fda) for the merit wrapsody™ endovascular stent graft system. the wrapsody system is a flexible, self-expanding endoprosthesis for which merit intends to seek 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 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. the wrapsody system is nearing completion of its “first in man” studies, and is not currently available for sale.
MMSI Ratings Summary
MMSI Quant Ranking