Merit Medical (NSDQ:MMSI) announced that it received CE Mark approval in Europe for its Wrapsody endovascular stent graft system.
Wrapsody is a flexible, self-expanding endoprosthesis indicated for use in hemodialysis patients for treating stenosis or occlusion within central veins, along with the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft, according to a news release.
In the U.S., Wrapsody won an FDA breakthrough nod in November 2019 for hemodialysis treatment, then added indications for stenosis or occlusion within the dialysis outflow circuit just last month. The company also recently completed enrollment and primary follow-up for its Wrapsody First study, which includes 46 patients in Europe.
Merit said in the release that it plans to offer additional products that utilize the Wrapsody platform, subject to additional regulatory submissions. It also plans to submit a pre-market approval application to the FDA once it concludes its Wave pivotal study.
“We are pleased to receive this certificate and the opportunity to offer this unique product to the European community,” Merit chairman & CEO Fred Lampropoulos said in the release. “I want to thank the principal investigators of the Wrapsody First study as well as our research and development, medical affairs and regulatory affairs staff members who worked tirelessly on this project.”