Merit Medical has announced the successful enrollment of the first patient in its WRAP registry study in a press release. The study will evaluate the clinical benefits associated with the use of the Wrapsody cell-impermeable endoprosthesis in patients receiving hemodialysis that experience stenosis or occlusion of blood vessels required for dialysis.
Globally, over 2 million patients with advanced kidney disease receive dialysis. Hemodialysis, the primary approach used for dialysis, requires long-term vascular access that is typically achieved through the surgical creation of an arteriovenous fistula (AVF) or placement of an arteriovenous graft (AVG). However, complications, such as stenosis and/or occlusion within the dialysis outflow circuit of an AVF or AVG, can impair vascular access which compromises the ability to provide adequate dialysis treatment. The Wrapsody cell-impermeable endoprosthesis was created to help overcome this challenge by maintaining the integrity of the dialysis outflow circuit.
Dean Huang, MD, consultant diagnostic and interventional radiologist at King’s College Hospital in London, England, enrolled the first patient in the WRAP Registry. “The patients being treated with the Wrapsody cell-impermeable endoprosthesis have historically had few clinical options,” Huang said. “These patients have typically faced frequent reinterventions to maintain vessel patency resulting in multiple procedures and hospitalizations. The WRAP study will add to the growing body of evidence on Wrapsody’s ability to achieve durable outcomes for this vulnerable patient population.”
The WRAP registry study will enroll up to 500 patients with outflow circuit stenosis or occlusion who are receiving hemodialysis at medical facilities throughout Europe, South America, Australia, and New Zealand. Clinical outcomes of patients after the initial placement of the Wrapsody cell-impermeable endoprosthesis will be evaluated over a two-year period in accordance with the instructions for use associated with its CE Mark.
The Wrapsody cell-impermeable endoprosthesis is an expandable nitinol stent frame fully enveloped by an external layer of expanded polytetrafluoroethylene (PTFE) and an internal layer of spun PTFE with an interposed cell-impermeable layer. The Wrapsody cell-impermeable endoprosthesis system is being studied under an investigational device exemption (IDE) in the U.S.
