Merit Medical Announces Health Canada Approval of the WRAPSODY® Cell-Impermeable Endoprosthesis

• The WRAPSODY CIE is designed to assist physicians delay practical vascular entry in hemodialysis sufferers.
• Approval was supported by superior 12-month goal lesion main patency (70.1%) and entry circuit main patency (58.1%) in the randomized arm of the trial.

SOUTH JORDAN, Utah, Might 06, 2025 (GLOBE NEWSWIRE) — Merit Medical Programs, Inc. (NASDAQ: MMSI), a world chief of healthcare expertise, introduced at present that the Wrapsody Cell-Impermeable Endoprosthesis (CIE) obtained regulatory approval from Health Canada. With this approval, Merit intends to start rapid commercialization of the system all through Canada with gadgets shipped from Merit’s Toronto distribution middle.

Lengthy-term entry to blood vessels (vascular entry) is essential for sufferers present process hemodialysis. Nevertheless, stenosis, a narrowing of blood vessels, is a typical complication that may have life-threatening penalties if not resolved. Intervention choices for sufferers affected by stenosis have been restricted. The WRAPSODY CIE was developed to assist physicians successfully deal with sufferers on hemodialysis who expertise vascular entry stenosis.

In 2010, Merit got down to perceive how and why earlier gadgets failed to supply lasting advantages to sufferers. It turned evident that in the earlier technology of coated stents/stent grafts a considerable trigger of system failure and, in the end, loss of vascular entry, was the presence of tissue inside the polytetrafluoroethylene (PTFE) layer.

With this understanding and key scientific perception from Bart Dolmatch, MD, FSIR, Interventional Radiologist at The Palo Alto Medical Basis in Palo Alto, California, engineers at Merit designed the WRAPSODY CIE. The tri-layer design of the system is in contrast to every other therapy choice at present obtainable. The three layers of the WRAPSODY CIE consist of: (1) an expandable nitinol stent body absolutely enveloped by an outer layer of expanded PTFE; (2) a cell-impermeable center layer that stops tissue accumulation and migration; and (3) an innermost inside layer that consists of novel “spun” PTFE to scale back fibrin and thrombus formation. Different distinctive options of the WRAPSODY CIE embrace optimized radial pressure, excessive compression resistance, and softened ends, all of which assist the system conform to vessels, cut back stress, and enhance dialysis effectiveness. “I consider all of these developments will translate to higher outcomes for sufferers on hemodialysis,” stated Dr. Dolmatch, who was instrumental in the growth of the WRAPSODY CIE.

Outcomes from the randomized arm of the WRAPSODY Arteriovenous Entry Efficacy (WAVE) trial demonstrated that the WRAPSODY CIE is related to considerably greater main patency in comparison with percutaneous transluminal angioplasty (PTA). At six months, the goal lesion main patency of the WRAPSODY CIE vs. PTA was 89.8% vs. 62.8% (p<0.0001), and the entry circuit main patency was 72.6% vs. 57.9% (p=0.015). At 12 months, the WRAPSODY CIE remained considerably greater than PTA for each goal lesion main patency (70.1% vs. 41.6%, p<0.0001) and entry circuit main patency (58.1% vs. 34.4%, p=0.0003).

“Given the distinctive vulnerabilities sufferers on hemodialysis expertise, WRAPSODY’s skill to revive vascular entry performance and keep away from disruptions in hemodialysis administration is of excessive worth to sufferers and suppliers,” stated Dheeraj Ok. Rajan, MD, FRCPC, FSIR, FACR, Professor and Division Head in the Division of Vascular Interventional Radiology at the College of Toronto in Toronto, Canada, and an investigator in the WAVE trial. “The truth that WRAPSODY is related to excessive goal lesion and entry circuit main patencies not beforehand noticed in any related scientific trial to this point is compelling and can present the choice to lift the customary for greatest affected person care in Canada.”

“Our WRAPSODY journey is a testomony to our willpower at Merit to grasp, innovate, and ship the highest high quality merchandise to assist our doctor companions obtain the greatest outcomes potential for sufferers,” stated Fred P. Lampropoulos, Merit’s Chairman and Chief Govt Officer. “We’re dedicated to remaining at the forefront of hemodialysis care.”

The WRAPSODY CIE obtained premarket approval (PMA) from the US Meals and Drug Administration (FDA) in December 2024. Merit started commercialization of the system in the United States in January 2025. The system beforehand obtained the Conformité Européenne (CE) Mark for industrial use in the European Union and is out there in Brazil.

For added data on Merit Medical’s WAVE trial, please go to: https://clinicaltrials.gov/ct2/present/NCT04540302. 

ABOUT MERIT

Based in 1987, Merit Medical Programs, Inc. is engaged in the growth, manufacture, and distribution of proprietary disposable medical gadgets utilized in interventional, diagnostic, and therapeutic procedures, significantly in cardiology, radiology, oncology, essential care, and endoscopy. Merit serves consumer hospitals worldwide with a home and worldwide gross sales pressure and scientific assist staff totaling greater than 800 people. Merit employs roughly 7,300 folks worldwide. 

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