Merit Medical Systems has enrolled the first subject in the multi-centre, prospective trial, WRAP North America registry, aimed at collecting data on the effectiveness and safety of the Wrapsody cell-impermeable endoprosthesis (CIE) device in a real-world clinical setting.
The subject was enrolled at Bluff City Vascular’s interventional nephrology and vascular access centre in the US by the site鈥檚 medical director and president, Omar Davis, who is also serving as an investigator for the registry.
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The WRAP North America registry is targeting an inclusion of up to 250 subjects from the US and Canada who are receiving haemodialysis and are affected by venous obstructions, such as blockages or narrowing, which compromise their vascular access.
Merit鈥檚 device has been developed to aid healthcare providers in restoring vascular access for this patient population.
The trial鈥檚 protocol includes a three-year assessment of the clinical outcomes for those who have been treated with the device.
Merit Medical Systems CEO and chairman Fred Lampropoulos said: 鈥淭he first patient enrolled in the WRAP North America registry is an important milestone in our ongoing efforts to collect the highest quality of evidence regarding the Wrapsody CIE鈥檚 performance.鈥�
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By GlobalDataIn parallel, the WRAP Global registry, another Merit-conducted trial, is evaluating the real-world outcomes of the Wrapsody CIE.
This study aims to enrol up to 500 subjects from outside North America, with the final enrolment anticipated by this year-end.
The Wrapsody CIE had previously demonstrated its performance in the Wrapsody arteriovenous access efficacy (WAVE) pivotal study.
This trial was divided into two parts, which included a randomised arm in which the device or percutaneous transluminal angioplasty (PTA) was used for treating those with an arteriovenous fistula (AVF).
The non-randomised arm compared the clinical outcomes of individuals with an arteriovenous graft (AVG) to historical data of AVG patients who received treatment with earlier generations of covered stents.
In December 2024, the US Food and Drug Administration (FDA) granted premarket approval to Wrapsody CIE.
In May 2025, Merit Medical further expanded its operations by acquiring US-based haemostatic device manufacturer Biolife Delaware in a deal worth $120m.
