Merit’s Wrapsody CIE Approved by Health Canada

May 13, 2025—Merit Medical Systems, Inc. announced recently that the company’s Wrapsody cell-impermeable endoprosthesis (CIE) received regulatory approval from Health Canada. The device is intended to help physicians prolong functional vascular access in hemodialysis patients.

Merit advised it will immediately begin commercialization of Wrapsody CIE throughout Canada with devices shipped from the company’s Toronto distribution center.

According to Merit, approval by Health Canada was supported by results from the Wrapsody Arteriovenous Access Efficacy (WAVE) trial.

As summarized in the company’s press release, the randomized arm of WAVE demonstrated that Wrapsody CIE is associated with significantly higher primary patency compared to percutaneous transluminal angioplasty (PTA):

• At 6-months, Wrapsody CIE compared to PTA demonstrated target lesion primary patency of 89.8% versus 62.8% (P < .0001) and access circuit primary patency of 72.6% versus 57.9% (P = .015).
• At 12 months, Wrapsody CIE remained significantly higher than PTA for both target lesion primary patency (70.1% vs 41.6%; P < .0001) and access circuit primary patency (58.1% vs 34.4%; P =.0003).

“Given the unique vulnerabilities patients on hemodialysis experience, Wrapsody’s ability to restore vascular access functionality and avoid disruptions in hemodialysis administration is of high value to patients and providers,” commented WAVE investigator Dheeraj K. Rajan, MD, in Merit’s press release.

Dr. Rajan, who is Professor and Division Head in the Department of Vascular Interventional Radiology at the University of Toronto in Toronto, Canada, continued, “The fact that Wrapsody is associated with high target lesion and access circuit primary patencies not previously observed in any similar clinical trial to date is compelling and will provide the option to raise the standard for best patient care in Canada.”

On March 25, the company announced the publication of 6-month data and presentation of 12-month data from WAVE.

In December 2024, Merit announced that the Wrapsody CIE received FDA premarket approval. The company began commercialization of the device in the United States in January 2025.

The company announced CE Mark approval for commercial use of Wrapsody CIT in the European Union in May 2020. The device is also commercially available in Brazil, stated Merit.