Merit Medical’s Wrapsody Receives FDA Approval

December 20, 2024—Merit Medical Systems, Inc. announced that the Wrapsody cell-impermeable endoprosthesis has received premarket approval from the FDA. The company stated that it can begin commercialization of the device in the United States in 2025.

According to the company, the Wrapsody device is a flexible, self-expanding endoprosthesis indicated for use in hemodialysis patients for the treatment of stenosis or occlusion within the dialysis access outflow circuit, including stenosis or occlusion: In the peripheral veins of individuals with an arteriovenous (AV) fistula and at the venous anastomosis of a synthetic AV graft.

Merit noted that since 2010, it has collaborated with Bart Dolmatch, MD, an interventional radiologist at Palo Alto Medical Foundation in Palo Alto, California, to develop the Wrapsody device.

“Preserving vascular access for dialysis patients is critical for them to maintain lifesaving treatment,” commented Dr. Dolmatch, credited as co-inventor of Wrapsody, in the company’s press release. “I believe the advancements that the Wrapsody device offers will translate to better outcomes for hemodialysis patients.”

Merit stated that Wrapsody is designed to extend long-term vessel patency in dialysis patients. The device’s covering features a nitinol stent frame enveloped by an expandable polytetrafluoroethylene (PTFE) outer layer; an inner-luminal layer of “spun” PTFE that is designed to reduce platelet and fibrin formation; and a middle cell-impermeable layer designed to prevent transgraft tissue migration or accumulation. The nitinol frame is intended to provide enhanced radial force, compression resistance, and softened ends to help the device conform to vessels, withstand physiological compression, and reduce stress on vessel walls, noted the company.

Results from the WAVE pivotal trial demonstrated that AV fistula and AV graft patients treated with the Wrapsody device for dialysis outflow lesions achieved a target lesion primary patency of 89.8% and 82.0%, respectively, at 6 months. The primary patency of the entire access circuit at 6 months in patients with an AV fistula and AV graft were 72.6% and 68.8%, respectively.

On November 24, 2024, Merit announced that the 6-month findings from the AV graft cohort of the WAVE pivotal trial were presented during the Novel Technologies in Hemodialysis Access session at the 51st annual VEITHsymposium held November 19-23 in New York, New York.

On September 16, 2024, the company announced that the 6-month findings from AV fistula arm of WAVE were presented at CIRSE 2024, the Cardiovascular and Interventional Radiological Society of Europe annual meeting held September 14-18 in Lisbon, Portugal.

Mahmood K. Razavi, MD, an interventional radiologist and Medical Director of Clinical Research at St. Joseph Heart and Vascular Center in Orange, California, served as coprincipal investigator of the WAVE trial.

“Historically, interventions for patients who experience a stenosis in their AV fistula or AV graft have not provided sustained clinical benefits and often require multiple re-interventions,” commented Dr. Razavi in Merit Medical’s press release. “Results from the WAVE trial have demonstrated that the Wrapsody device is associated with high patency rates and is likely to become the new standard of care.”