Merit Medical (NSDQ:MMSI) systems announced that it won two additional breakthrough device designations from the FDA for its Wrapsody endovascular stent graft system.
Wrapsody is designed as a flexible, self-expanding endoprosthesis and won a breakthrough nod in November 2019 for hemodialysis treatment.
Its latest indications include treating stenosis or occlusion within the dialysis outflow circuit, including within the peripheral veins in the arm of arteriovenous ristula (AVF) patients and within the thoracic central veins, up to the superior vena cava, in arteriovenous graft (AVG) patients.
Merit Medical believes the indications will increase patient access to the potentially life-savingtreatment, according to a news release.
That falls in line 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 is not currently available for sale in the U.S., though.
Original Article: (https://www.massdevice.com/merit-medical-wins-fda-breakthrough-nods/)
