Merit Medical (NSDQ:MMSI) announced last week that it has been granted FDA breakthrough device designation for its Wrapsody endovascular stent graft system.
Wrapsody is a flexible, self-expanding endoprosthesis designed for hemodialysis patients. Merit said it will seek indication to treat stenosis within the central veins of the outflow circuit of an arteriovenous fistula (AVF) up to the superior vena cava.
“We are pleased with the recognition by the FDA of this worthwhile technology as well as the efforts of many members of our R&D team to bring the project to this point,” said Merit CEO Fred Lampropoulos in a news release. “Most importantly, we believe this system will provide substantial benefits to patients who may utilize the system in the future.”
Merit Medical’s announcement came in the same week as Medtronic’s (NYSE:MDT) for the FDA approval of its IN.PACT AV paclitaxel-coated balloon meant to treat reoccurring blood vessel narrowing that delays people with end-stage renal disease from receiving needed dialysis.
These innovations dovetail with the Trump administration’s plan, announced in July, to overhaul the way kidney disease is treated in the U.S., including an emphasis on home hemodialysis instead of in-clinic treatment.
The Wrapsody system is nearing completion of its first-in-human studies, and is not currently available for sale.
Shares in MMI were up 2% in early trading to $27.65.