Merit Medical Pivotal Study Enrolls Patients

 U.S. pivotal study to determine safety and effectiveness of the WRAPSODY Endovascular Stent Graft System in the treatment of dialysis outflow circuit stenosis or occlusion

SOUTH JORDAN, Utah, March 11, 2021 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today the enrollment of the first patients in its Wrapsody ArterioVenous (AV) Access Efficacy Pivotal Study (the “WAVE Study”) of the WRAPSODY™ Endovascular Stent Graft, an investigational device being studied for the treatment of stenosis or occlusion within dialysis outflow circuits. Jeffrey Hoggard, MD at RAC Surgery Center LLC, Raleigh, NC successfully enrolled the first two subjects with venous outflow peripheral lesions.

“We are pleased to announce the first subjects enrolled into the Merit Medical WAVE study. Stent grafts have a proven track record in dialysis AV access, and we are excited to evaluate the WRAPSODY Stent Graft in our patients for this clinical trial,” said Jeffrey Hoggard, MD.

Over two million patients with kidney disease worldwide receive hemodialysis. Preferred long-term vascular access in these patients is generally achieved by the surgical creation of an arteriovenous fistula (AVF) or implantation of an arteriovenous graft (AVG)1. Vascular access circuit dysfunction is a common complication over time in AVFs and AVGs, accounting for 20% of hospitalizations in end-stage renal disease patients2. Stenosis or occlusion of these vascular access circuits is most common in the venous outflow segment3.

The WRAPSODY Endovascular Stent Graft is an investigational device with an expandable nitinol stent frame fully enveloped by an external layer of expanded polytetrafluoroethylene (ePTFE) and an internal layer of spun PTFE with an interposed non-porous fluoropolymer bonding layer.

https://finance.yahoo.com/news/first-patients-enrolled-merit-wrapsody-202800261.html