Merit Medical Releases 12-Month Efficacy Results of the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE)
Merit Medical Systems (NASDAQ: MMSI) has announced significant results from their WRAPSODY Arteriovenous Access Efficacy (WAVE) trial, evaluating their WRAPSODY Cell-Impermeable Endoprosthesis (CIE) device for hemodialysis patients. The device, which received FDA approval in December 2024, showed impressive efficacy in treating venous stenosis.
The multicenter trial compared WRAPSODY CIE (n=122) against standard angioplasty (PTA, n=123). At 6 months, WRAPSODY demonstrated superior results with 89.8% target lesion primary patency versus 62.8% for PTA, and 72.6% access circuit primary patency versus 57.9%. At 12 months, the device maintained significantly higher rates with 70.1% target lesion primary patency versus 41.6%, and 58.1% access circuit primary patency versus 34.4%.
Merit Medical began U.S. commercialization in January 2025, with the device already available in the European Union and Brazil.
Merit Medical Systems (NASDAQ: MMSI) ha annunciato risultati significativi dal loro trial WRAPSODY Arteriovenous Access Efficacy (WAVE), che valuta il dispositivo WRAPSODY Cell-Impermeable Endoprosthesis (CIE) per i pazienti in emodialisi. Il dispositivo, che ha ricevuto l'approvazione della FDA nel dicembre 2024, ha mostrato un'efficacia impressionante nel trattamento della stenosi venosa.
Il trial multicentrico ha confrontato il WRAPSODY CIE (n=122) con l'angioplastica standard (PTA, n=123). A 6 mesi, WRAPSODY ha dimostrato risultati superiori con un 89,8% di patenza primaria della lesione target rispetto al 62,8% per PTA, e un 72,6% di patenza primaria del circuito di accesso rispetto al 57,9%. A 12 mesi, il dispositivo ha mantenuto tassi significativamente più elevati con un 70,1% di patenza primaria della lesione target rispetto al 41,6%, e un 58,1% di patenza primaria del circuito di accesso rispetto al 34,4%.
Merit Medical ha avviato la commercializzazione negli Stati Uniti a gennaio 2025, con il dispositivo già disponibile nell'Unione Europea e in Brasile.
Merit Medical Systems (NASDAQ: MMSI) ha anunciado resultados significativos de su ensayo WRAPSODY Arteriovenous Access Efficacy (WAVE), que evalúa su dispositivo WRAPSODY Cell-Impermeable Endoprosthesis (CIE) para pacientes en hemodiálisis. El dispositivo, que recibió la aprobación de la FDA en diciembre de 2024, mostró una eficacia impresionante en el tratamiento de la estenosis venosa.
El ensayo multicéntrico comparó WRAPSODY CIE (n=122) con la angioplastia estándar (PTA, n=123). A los 6 meses, WRAPSODY demostró resultados superiores con un 89.8% de patencia primaria de la lesión objetivo frente al 62.8% para PTA, y un 72.6% de patencia primaria del circuito de acceso frente al 57.9%. A los 12 meses, el dispositivo mantuvo tasas significativamente más altas con un 70.1% de patencia primaria de la lesión objetivo frente al 41.6%, y un 58.1% de patencia primaria del circuito de acceso frente al 34.4%.
Merit Medical comenzó la comercialización en EE. UU. en enero de 2025, con el dispositivo ya disponible en la Unión Europea y Brasil.
Merit Medical Systems (NASDAQ: MMSI)는 혈액 투석 환자를 위한 WRAPSODY Cell-Impermeable Endoprosthesis (CIE) 장치에 대한 WRAPSODY Arteriovenous Access Efficacy (WAVE) 시험의 중요한 결과를 발표했습니다. 이 장치는 2024년 12월 FDA 승인을 받았으며, 정맥 협착 치료에서 인상적인 효능을 보였습니다.
다기관 시험에서는 WRAPSODY CIE (n=122)를 표준 혈관 성형술 (PTA, n=123)과 비교했습니다. 6개월 후, WRAPSODY는 89.8%의 목표 병변 1차 개통성을 기록하며 PTA의 62.8%보다 우수한 결과를 보였고, 72.6%의 접근 회로 1차 개통성을 기록하며 PTA의 57.9%보다 높았습니다. 12개월 후, 이 장치는 70.1%의 목표 병변 1차 개통성을 유지하며 41.6%보다 높았고, 58.1%의 접근 회로 1차 개통성을 유지하며 34.4%보다 높았습니다.
Merit Medical은 2025년 1월 미국에서 상용화를 시작했으며, 이 장치는 이미 유럽연합과 브라질에서 사용 가능합니다.
Merit Medical Systems (NASDAQ: MMSI) a annoncé des résultats significatifs de leur essai WRAPSODY Arteriovenous Access Efficacy (WAVE), évaluant leur dispositif WRAPSODY Cell-Impermeable Endoprosthesis (CIE) pour les patients sous hémodialyse. Le dispositif, qui a reçu l'approbation de la FDA en décembre 2024, a montré une efficacité impressionnante dans le traitement de la sténose veineuse.
L'essai multicentrique a comparé WRAPSODY CIE (n=122) à l'angioplastie standard (PTA, n=123). À 6 mois, WRAPSODY a démontré des résultats supérieurs avec une 89,8% de patence primaire de la lésion cible contre 62,8% pour PTA, et une 72,6% de patence primaire du circuit d'accès contre 57,9%. À 12 mois, le dispositif a maintenu des taux significativement plus élevés avec une 70,1% de patence primaire de la lésion cible contre 41,6%, et une 58,1% de patence primaire du circuit d'accès contre 34,4%.
Merit Medical a commencé la commercialisation aux États-Unis en janvier 2025, le dispositif étant déjà disponible dans l'Union européenne et au Brésil.
Merit Medical Systems (NASDAQ: MMSI) hat bedeutende Ergebnisse aus ihrer WRAPSODY Arteriovenous Access Efficacy (WAVE) Studie bekannt gegeben, die ihr WRAPSODY Cell-Impermeable Endoprosthesis (CIE) Gerät für Hämodialysepatienten bewertet. Das Gerät, das im Dezember 2024 von der FDA zugelassen wurde, zeigte eine beeindruckende Wirksamkeit bei der Behandlung von venöser Stenose.
Die multizentrische Studie verglich WRAPSODY CIE (n=122) mit der Standardangioplastie (PTA, n=123). Nach 6 Monaten zeigte WRAPSODY überlegene Ergebnisse mit einer 89,8% primären Patenz des Zielherdes im Vergleich zu 62,8% für PTA, und einer 72,6% primären Patenz des Zugangszyklus im Vergleich zu 57,9%. Nach 12 Monaten hielt das Gerät signifikant höhere Raten mit einer 70,1% primären Patenz des Zielherdes im Vergleich zu 41,6%, und einer 58,1% primären Patenz des Zugangszyklus im Vergleich zu 34,4% aufrecht.
Merit Medical begann im Januar 2025 mit der Kommerzialisierung in den USA, wobei das Gerät bereits in der Europäischen Union und Brasilien erhältlich ist.
- FDA approval received in December 2024
- Significantly superior efficacy compared to standard treatment
- Strong 12-month patency rates (70.1% target lesion, 58.1% access circuit)
- Already commercialized in multiple markets (US, EU, Brazil)
- No significant safety concerns compared to standard treatment
- Efficacy rates show decline from 6 months (89.8%) to 12 months (70.1%)
- Access circuit primary patency drops to 58.1% at 12 months
Insights
Merit Medical's 12-month WAVE trial results for the WRAPSODY CIE demonstrate statistically significant superiority over standard percutaneous transluminal angioplasty (PTA) for maintaining vascular access in hemodialysis patients. The device showed
These results are clinically meaningful because maintaining functional vascular access is critical for hemodialysis patients' survival. When access sites fail, patients require additional interventions, leading to treatment disruptions, increased complication risks, and higher healthcare costs. The WRAPSODY device addresses the common problem of venous stenosis that compromises arteriovenous fistulas used for dialysis access.
Merit already secured FDA approval (December 2024) and began U.S. commercialization (January 2025), with the device already available in Europe and Brazil. The publication of these positive 12-month outcomes in a respected journal and presentation at a major medical conference provides strong clinical evidence that should support physician adoption. The timing of these results aligns perfectly with Merit's commercial launch phase, potentially accelerating early market penetration for this differentiated vascular access maintenance technology.
- At 6 months, the WRAPSODY CIE achieved
89.8% and72.6% target lesion primary patency and access circuit primary patency, respectively. - At 12 months, the WRAPSODY CIE achieved
70.1% and58.1% target lesion primary patency and access circuit primary patency, respectively.
SOUTH JORDAN, Utah, March 25, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced that the six-month results from the randomized arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial are scheduled for publication in the April issue of Kidney International. Twelve-month results from the randomized arm of the WAVE trial are scheduled for presentation at the Society of Interventional Radiology’s 50th Annual Scientific Meeting in Nashville, TN. The podium presentation is scheduled for March 30, 2025, during the late-breaking trials session.
The creation of an arteriovenous fistula (AVF) to achieve long-term access to blood vessels (vascular access) is required for patients undergoing hemodialysis. However, narrowing (stenosis) of blood vessels in and around the AVF can interfere with hemodialysis delivery, resulting in potentially life-threatening consequences. The WRAPSODY CIE is designed to help clinicians restore vascular access in patients on hemodialysis who experience stenosis in their venous outflow circuit.
The WAVE trial is a multicenter, international, investigational device exemption (IDE) trial designed to evaluate the WRAPSODY CIE’s safety and efficacy over two years. In the randomized arm of the trial, 245 patients on hemodialysis who experienced stenosis in the venous outflow of their AVF were treated with the WRAPSODY CIE (n=122) or standard percutaneous transluminal angioplasty (PTA, n=123).
Treatment efficacy was defined as the proportion of patients who did not require an intervention due to clinically driven target lesion revascularization or target lesion thrombosis (target lesion primary patency). An additional efficacy endpoint was the proportion of patients without loss of vascular access anywhere within the circuit from the time of their initial treatment to the need for reintervention or abandonment of vascular access (access circuit primary patency).
Primary safety was defined as the proportion of patients with safety events that negatively affected the vascular access or venous outflow circuit, excluding target lesion revascularization or thrombosis, which resulted in reintervention, hospitalization, or death.
Initial results at six months demonstrated that the target lesion primary patency was significantly higher for the WRAPSODY CIE vs. PTA (
“The WRAPSODY CIE’s positive outcomes at one year address an important knowledge gap regarding the potential durability of the device,” said Dheeraj K. Rajan, MD, FRCPC, FSIR, FACR, Professor and Division Head in the Department of Vascular Interventional Radiology at the University of Toronto in Toronto, Canada, and WAVE trial investigator. “It is encouraging to know there is a new device available to help us prolong functional vascular access in our patients.”
“At Merit, we are pleased to continue building on the superior results of the WRAPSODY CIE,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We are committed to improving patient care and providing clinicians with the data they need to make evidence-based decisions.”
The WRAPSODY CIE received premarket approval (PMA) from the US Food and Drug Administration (FDA) in December 2024. Merit began commercialization of the device in the United States in January 2025. The device previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil.
For additional information on Merit Medical’s WAVE trial, please visit: https://clinicaltrials.gov/ct2/show/NCT04540302.
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 customers worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,400 people worldwide.
TRADEMARKS
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors.
CONTACTS
PR/Media Inquiries
Sarah Comstock
Merit Medical
+1-801-432-2864 | sarah.comstock@merit.com
INVESTOR INQUIRIES
Mike Piccinino, CFA, IRC
Westwicke - ICR
+1-443-213-0509 | mike.piccinino@westwicke.com
FAQ
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