The trial aims to compare Merit WRAPSODY CIE with percutaneous transluminal angioplasty to treat stenosis/occlusion in the venous outflow circuit in haemodialysis patients. Credit: sfam_photo / Shutterstock.com.

Merit Medical Systems has concluded the enrolment of patients in the WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial.

The study is intended to compare the Merit WRAPSODY Cell-Impermeable Endoprosthesis (CIE) with percutaneous transluminal angioplasty to treat stenosis/occlusion in the venous outflow circuit in patients undergoing haemodialysis.        

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The prospective, multicentre, randomised and controlled trial enrolled 244 patients with arteriovenous fistula, as well as 113 patients with arteriovenous graft across sites in the UK, the US, Canada and Brazil.

After the completion of six months post-enrolment, the company plans to file primary outcomes with the US Food and Drug Administration (FDA) for premarket approval (PMA).

The company aims to track patients from the WAVE study for 24 months.

Merit will gather efficacy and safety outcomes throughout the follow-up period of the trial.

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Merit chairman and CEO Fred Lampropoulos said: “Enrolment of the last patients in the WAVE study represents an important milestone.

“We believe it will enable us to provide critical insight to our physician partners and support our submission of a PMA Application to the FDA.”

The Merit WRAPSODY Cell-Impermeable Endoprosthesis is currently not approved for sale in the US and its availability for purchase or use in other countries is also undetermined.

The device previously received CE mark approval for commercial application in the European Union. It is also available in Brazil and is being utilised under an investigational device exemption granted by the FDA in the US.