First Patient Enrolled in Merit Medical’s WRAPSODY (WRAP) North America Registry
Merit Medical Systems (NASDAQ: MMSI) has announced the enrollment of the first patient in its WRAP North America registry study at Bluff City Vascular in Memphis, TN. The registry will evaluate the real-world safety and effectiveness of the WRAPSODY Cell-Impermeable Endoprosthesis (CIE), a device designed to restore vascular access in hemodialysis patients.
The study aims to enroll up to 250 patients across the US and Canada, following them for three years. This registry complements the ongoing WRAP Global registry, which targets 500 non-North American patients. The WRAPSODY CIE received FDA approval in December 2024 and Health Canada approval in April 2025, following earlier approvals in the EU and Brazil.
Merit Medical Systems (NASDAQ: MMSI) ha annunciato l'arruolamento del primo paziente nel registro WRAP North America presso Bluff City Vascular a Memphis, TN. Il registro valuterà la sicurezza e l'efficacia nel mondo reale del WRAPSODY Cell-Impermeable Endoprosthesis (CIE), un dispositivo pensato per ripristinare l'accesso vascolare nei pazienti in emodialisi.
Lo studio prevede di arruolare fino a 250 pazienti in USA e Canada, con un follow-up di tre anni. Questo registro integra il registro WRAP Global in corso, che mira a includere 500 pazienti al di fuori del Nord America. Il WRAPSODY CIE ha ottenuto la approvazione FDA nel dicembre 2024 e l'approvazione di Health Canada nell'aprile 2025, dopo precedenti autorizzazioni in UE e Brasile.
Merit Medical Systems (NASDAQ: MMSI) ha anunciado la inscripción del primer paciente en su estudio de registro WRAP North America en Bluff City Vascular en Memphis, TN. El registro evaluará la seguridad y la eficacia en condiciones reales del WRAPSODY Cell-Impermeable Endoprosthesis (CIE), un dispositivo diseñado para restaurar el acceso vascular en pacientes en hemodiálisis.
El estudio pretende reclutar hasta 250 pacientes en EE. UU. y Canadá, con seguimiento durante tres años. Este registro complementa el registro WRAP Global en curso, que tiene como objetivo 500 pacientes fuera de Norteamérica. El WRAPSODY CIE recibió la aprobación de la FDA en diciembre de 2024 y la aprobación de Health Canada en abril de 2025, tras autorizaciones previas en la UE y Brasil.
Merit Medical Systems (NASDAQ: MMSI)는 테네시주 멤피스의 Bluff City Vascular에서 WRAP North America 등록연구에 첫 환자 등록을 시작했다고 발표했습니다. 이 등록연구는 혈액투석 환자의 혈관 접근을 회복하기 위해 설계된 WRAPSODY Cell-Impermeable Endoprosthesis (CIE)의 실제 임상 환경에서의 안전성 및 유효성을 평가합니다.
연구는 미국과 캐나다에서 최대 250명의 환자를 등록하고 3년 동안 추적 관찰할 계획입니다. 이 등록연구는 비(非)북미 환자 500명을 목표로 하는 진행 중인 WRAP Global 등록과 보완 관계에 있습니다. WRAPSODY CIE는 2024년 12월 FDA 승인을 받았고, 2025년 4월 Health Canada 승인을 획득했으며 이전에 EU 및 브라질에서도 승인을 받았습니다.
Merit Medical Systems (NASDAQ: MMSI) a annoncé l'inclusion du premier patient dans son registre WRAP North America au Bluff City Vascular de Memphis, TN. Le registre évaluera la sécurité et l'efficacité en conditions réelles du WRAPSODY Cell-Impermeable Endoprosthesis (CIE), un dispositif destiné à restaurer l'accès vasculaire chez les patients en hémodialyse.
L'étude vise à enrôler jusqu'à 250 patients aux États-Unis et au Canada, avec un suivi sur trois ans. Ce registre complète le registre WRAP Global en cours, qui cible 500 patients hors Amérique du Nord. Le WRAPSODY CIE a reçu la autorisation de la FDA en décembre 2024 et l'approbation de Health Canada en avril 2025, après des approbations antérieures dans l'UE et au Brésil.
Merit Medical Systems (NASDAQ: MMSI) hat die Einschreibung des ersten Patienten in seine WRAP North America Registerstudie im Bluff City Vascular in Memphis, TN angekündigt. Das Register wird die Sicherheit und Wirksamkeit des WRAPSODY Cell-Impermeable Endoprosthesis (CIE) in der realen Praxis untersuchen – ein Gerät zur Wiederherstellung des Gefäßzugangs bei Hämodialysepatienten.
Die Studie plant, bis zu 250 Patienten in den USA und Kanada zu rekrutieren und diese über drei Jahre zu verfolgen. Dieses Register ergänzt das laufende WRAP Global-Register, das 500 Nicht-Nordamerikanische Patienten anvisiert. Der WRAPSODY CIE erhielt im Dezember 2024 die FDA-Zulassung und im April 2025 die Zulassung durch Health Canada, nach vorherigen Genehmigungen in der EU und Brasilien.
- None.
- Study completion and data collection will take three years
- Final enrollment in global registry not expected until end of 2025
- The WRAP North America registry is a prospective, multicenter study designed to collect real-world safety and effectiveness data on the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE).
- The first WRAP North America patient was enrolled at Bluff City Vascular, an interventional nephrology and vascular access center in Memphis, TN.
SOUTH JORDAN, Utah, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced today the successful enrollment of the first patient in the WRAP North America registry.
The WRAP North America registry is designed to enroll up to 250 US and Canadian patients on hemodialysis who experience obstructions, such as stenosis (narrowing) or occlusion (blockage) in the veins required for dialysis (vascular access). The WRAPSODY CIE is designed to help clinicians restore vascular access in patients on hemodialysis who experience such obstructions. The study protocol provides for evaluation of clinical outcomes in patients treated with the WRAPSODY CIE over three years. Omar Davis, MD, President and Medical Director at Bluff City Vascular and Investigator in the WRAP North America registry, enrolled the first patient in the registry.
“We appreciate the ingenuity and novelty of the WRAPSODY CIE,” said Dr. Davis. “Participation in this registry is an important opportunity for us to assess the ability of this device to optimize hemodialysis care for our patients.”
The superior performance of the WRAPSODY CIE in the clinical trial setting was previously demonstrated in the WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The WAVE trial included two arms. In the randomized arm, patients with an arteriovenous fistula (AVF) were treated with the WRAPSODY CIE or percutaneous transluminal angioplasty (PTA). In the non-randomized arm, clinical outcomes of patients with an arteriovenous graft (AVG) were compared to historical outcomes (i.e., performance goals) of AVG patients treated with previous-generation covered stents.
“The WRAPSODY CIE’s ability to restore vascular access for patients on hemodialysis who experience obstructions is promising,” said David J. Dexter II, MD, FACS, National Principal Investigator of the WRAP North America registry and Vascular Surgeon at Sentara Health Research Center in Norfolk, VA. “The opportunity to evaluate the WRAPSODY CIE’s real-world effectiveness will help address critical questions regarding the broader impact of its use in clinical practice.”
The WRAP North America registry is intended to add to Merit’s growing portfolio of clinical evidence supporting the WRAPSODY CIE. If completed as designed, it would represent the largest cohort of patients treated with an implantable device to restore vascular access for hemodialysis.
“The 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’s performance,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “Advancing technology that transforms lives through improved patient care is at the heart of what we do. Helping our physician partners shape the future of dialysis is both exciting and rewarding, and we look forward to seeing the difference that the WRAPSODY CIE makes in the lives of many patients.”
Real-world outcomes associated with the use of the WRAPSODY CIE are also being evaluated in the WRAP Global registry, also being conducted by Merit, which was designed to enroll up to 500 patients outside of North America. Final enrollment in the WRAP Global registry is expected by the end of 2025.
For additional information on Merit’s WRAP North America registry, please visit: https://clinicaltrials.gov/study/NCT06807099.
For additional information on Merit’s WRAP Global registry, please visit: https://www.clinicaltrials.gov/ct2/show/NCT05062291.
On December 19, 2024, the WRAPSODY CIE received premarket approval from the US Food and Drug Administration (FDA). On April 30, 2025, the device was approved by Health Canada. The WRAPSODY CIE previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil.
For more information on the WRAPSODY CIE, please visit: https://www.merit.com/product/wrapsody-cie/.
Any forward-looking statements set forth in this release are subject to risks and uncertainties such as those described in Merit's filings with the U. S. Securities and Exchange Commission (“SEC”). For discussion of the risks and uncertainties which may affect Merit’s business, operations and financial condition, see Part I, Item 1A, “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2024, Part II, Item 1A, “Risk Factors” in Merit’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 and Merit’s other filings with the SEC. Actual results will likely differ, and may differ materially, from anticipated results.
ABOUT MERIT
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,300 people worldwide.
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FAQ
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