Merit Medical’s Wrapsody Cell-Impermeable Endoprosthesis Studied in International WRAP Registry

July 5, 2022—Merit Medical Systems, Inc. announced the enrollment of the first patient in its WRAP Registry Study, which will evaluate the clinical benefits associated with the use of the company’s Wrapsody cell-impermeable endoprosthesis in patients receiving hemodialysis who experience stenosis occlusion of blood vessels required for vascular access.

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. European CE Mark approval of the device was announced in May 2020. Clinical outcomes of patients after the initial placement of the Wrapsody device will be evaluated over a 2-year period in accordance with the instructions for use associated with its CE Mark.

The first patient in the WRAP Registry was enrolled by Dean Huang, MD, consultant diagnostic and interventional radiologist at King’s College Hospital in London, United Kingdom.

“The patients being treated with the Wrapsody cell-impermeable endoprosthesis have historically had few clinical options,” commented Dr. Huang in Merit Medical’s press release. “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. We are excited to enroll the first patient in this important study.”

According to the company, the Wrapsody device was created to help overcome the challenge of stenosis and/or occlusion within the dialysis outflow circuit of an arteriovenous fistula or placement of an arteriovenous graft that can impair vascular access and compromise the ability to provide adequate dialysis treatment. The device 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 system is being studied under an investigational device exemption in the United States. It is not approved, cleared, or available for commercial distribution in the United States and may not be approved, cleared, or available for sale or use in other countries, advised Merit Medical.