Merit Medical to Present 6-Month Outcomes from Randomized Arm of WRAPSODY™ Arteriovenous Access Efficacy (WAVE) Pivotal Study at Two Upcoming Medical Meetings
Merit Medical Systems (NASDAQ: MMSI) announced plans to release findings from its WAVE study, examining the safety and efficacy of the WRAPSODY Cell-Impermeable Endoprosthesis for treating stenosis in the venous outflow circuit. The study enrolled 245 patients with arteriovenous fistula (AVF) stenosis and 113 with arteriovenous graft (AVG) stenosis.
Six-month safety and efficacy findings for the AVF cohort will be presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) on September 14, 2024, in Lisbon. Additional presentations are scheduled at CIRSE and the Controversies in Dialysis Access (CiDA) Symposium in October.
The WRAPSODY device is not yet approved in the US but has received CE Mark for use in the European Union and is available in Brazil. Results from the WAVE study are expected to support Merit's Premarket Approval application to the FDA for commercial use in the United States.
Merit Medical Systems (NASDAQ: MMSI) ha annunciato piani per rilasciare i risultati del suo studio WAVE, che esamina la sicurezza e l'efficacia della protesi endovascolare WRAPSODY impermeabile alle cellule per il trattamento della stenosi nel circuito di deflusso venoso. Lo studio ha arruolato 245 pazienti con stenosi della fistola arteriovenosa (AVF) e 113 con stenosi del innesto arteriovenoso (AVG).
I risultati di sicurezza ed efficacia a sei mesi per il gruppo AVF saranno presentati alla Società Cardiovascolare e Radiologica Interventistica d'Europa (CIRSE) il 14 settembre 2024, a Lisbona. Sono previste ulteriori presentazioni presso CIRSE e il Simposio Controversie nell'Accesso alla Dialisi (CiDA) in ottobre.
Il dispositivo WRAPSODY non è ancora approvato negli Stati Uniti, ma ha ricevuto il Marchio CE per l'uso nell'Unione Europea ed è disponibile in Brasile. I risultati dello studio WAVE sono attesi per supportare la domanda di approvazione anticipata di Merit presso la FDA per l'uso commerciale negli Stati Uniti.
Merit Medical Systems (NASDAQ: MMSI) anunció planes para publicar los hallazgos de su estudio WAVE, que examina la seguridad y eficacia de la Endoprótesis WRAPSODY impermeable a las células para tratar la estenosis en el circuito de salida venosa. El estudio incluyó a 245 pacientes con estenosis de fístula arteriovenosa (AVF) y 113 con estenosis de injerto arteriovenoso (AVG).
Los hallazgos de seguridad y eficacia a seis meses del grupo AVF se presentarán en la Sociedad Cardiovascular y Radiológica Intervencionista de Europa (CIRSE) el 14 de septiembre de 2024, en Lisboa. Se programan presentaciones adicionales en CIRSE y en el Simposio de Controversias en el Acceso a Diálisis (CiDA) en octubre.
El dispositivo WRAPSODY aún no está aprobado en EE. UU., pero ha recibido el Marcado CE para su uso en la Unión Europea y está disponible en Brasil. Se espera que los resultados del estudio WAVE respalden la solicitud de aprobación previa a la comercialización de Merit ante la FDA para su uso comercial en Estados Unidos.
Merit Medical Systems (NASDAQ: MMSI)는 정맥 배출 회로의 협착 치료를 위한 WRAPSODY 세포 불투과성 내장형 기구의 안전성과 효능을 조사한 WAVE 연구 결과를 발표할 계획을 발표했습니다. 이 연구는 동정맥 누공(AVF) 협착 환자 245명과 동정맥 이식(AVG) 협착 환자 113명을 등록했습니다.
AVF 집단의 6개월 안전성 및 효능 결과는 2024년 9월 14일 리스본에서 개최되는 유럽 심혈관 및 중재적 방사선 학회(CIRSE)에서 발표될 예정입니다. 추가 발표는 CIRSE 및 10월에 열리는 투석 접근의 논란(CiDA) 심포지엄에서 예정되어 있습니다.
WRAPSODY 장치는 아직 미국에서 승인되지 않았지만 유럽연합에서 사용을 위한 CE 마크를 받았으며, 브라질에서 사용 가능합니다. WAVE 연구 결과는 미국에서의 상업적 사용을 위한 FDA의 사전 승인 요청을 지원할 것으로 기대됩니다.
Merit Medical Systems (NASDAQ: MMSI) a annoncé des plans de publication des résultats de son étude WAVE, qui examine la sécurité et l'efficacité de la prothèse endovasculaire WRAPSODY imperméable aux cellules pour traiter la sténose dans le circuit de drainage veineux. L'étude a inclus 245 patients atteints de sténose de fistule arteriovenous (AVF) et 113 avec sténose de greffe arteriovenous (AVG).
Les résultats de sécurité et d'efficacité à six mois pour le groupe AVF seront présentés lors de la Société Européenne de Radiologie Interventionnelle et Cardiovasculaire (CIRSE) le 14 septembre 2024 à Lisbonne. D'autres présentations sont prévues à CIRSE et lors du Symposium sur les controverses en matière d'accès aux dialyses (CiDA) en octobre.
Le dispositif WRAPSODY n'est pas encore approuvé aux États-Unis, mais il a reçu le marquage CE pour une utilisation dans l'Union européenne et est disponible au Brésil. Les résultats de l'étude WAVE devraient soutenir la demande d'approbation préalable de Merit auprès de la FDA pour un usage commercial aux États-Unis.
Merit Medical Systems (NASDAQ: MMSI) hat Pläne angekündigt, die Ergebnisse seiner WAVE-Studie zu veröffentlichen, die die Sicherheit und Wirksamkeit des WRAPSODY zellimpermeablen Endoprothesen zur Behandlung der Stenose im venösen Abflusskreislauf untersucht. Die Studie schloss 245 Patienten mit arteriovenöser Fistel (AVF) Stenose und 113 mit arteriovenösem Transplantat (AVG) Stenose ein.
Die Sicherheits- und Wirksamkeitsdaten nach sechs Monaten für die AVF-Gruppe werden am 14. September 2024 auf der Kardiovaskulären und Interventionalen Radiologischen Gesellschaft Europas (CIRSE) in Lissabon vorgestellt. Weitere Präsentationen sind im Oktober bei CIRSE und dem Symposium Kontroversen im Dialysezugang (CiDA) geplant.
Das WRAPSODY-Gerät ist in den USA noch nicht zugelassen, hat jedoch die CE-Kennzeichnung für die Verwendung in der Europäischen Union erhalten und ist in Brasilien erhältlich. Die Ergebnisse der WAVE-Studie werden voraussichtlich Merit bei der Antragstellung auf vorzeitige Genehmigung durch die FDA für die kommerzielle Nutzung in den Vereinigten Staaten unterstützen.
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SOUTH JORDAN, Utah, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced plans to release findings from its WAVE study. A pivotal, international, multicenter trial, the WAVE study examines the safety and efficacy of Merit’s WRAPSODY Cell-Impermeable Endoprosthesis for treatment of stenosis in the venous outflow circuit.
The WAVE study enrolled 245 patients with stenosis in their arteriovenous fistula (AVF) and 113 patients with evidence of stenosis in their arteriovenous graft (AVG). Patients with an AVF were randomized 1:1 to treatment with WRAPSODY or standard of care with percutaneous transluminal angioplasty (PTA). Safety and performance outcomes of patients with an AVG were compared to historical controls. Patients enrolled in WAVE will be followed for 24 months after their initial intervention. Six-month safety and efficacy findings will be presented at multiple congresses this year.
The first release of results will focus exclusively on patients from the randomized arm of the study (AVF cohort) and is scheduled for scientific presentation at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in Lisbon, Portugal. The presentation is scheduled for Saturday, September 14, during the FIRST@CIRSE scientific session held from 11:30 a.m. to 12:30 p.m. (CEST); specific results at 6 months will include target lesion primary patency, access circuit primary patency, and safety events.
“Given the limited options available to help maintain the vascular access in patients requiring hemodialysis, it is critical to provide the clinical community with information on the latest technology designed to help us optimize care for such a vulnerable patient group,” said Mahmood K. Razavi, MD, FSIR, FSVM, Medical Director of Clinical Research at St. Joseph Heart and Vascular Center in Orange, California, and Co-Global Principal Investigator of the WAVE study. “I look forward to presenting the first release of the findings at CIRSE.”
Following the presentation of 6-month outcomes of the randomized arm of the WAVE study, there will be a Merit-sponsored symposium at CIRSE on Monday, September 16, from 1:00 p.m. to 2:00 p.m. (CEST), with a panel of renowned experts highlighting the latest hemodialysis evidence and clinical strategies. On Tuesday, September 17, from 1:30 p.m. to 2:30 p.m. (CEST), Merit will host a case discussion and hands-on session.
Saravanan Balamuthusamy, MD, FASN, Interventional Nephrologist at PPG Health in Fort Worth, Texas, and a WAVE study investigator, will present core laboratory findings supporting the cell-impermeable design of WRAPSODY at the industry-sponsored Controversies in Dialysis Access (CiDA) Symposium on Saturday, October 5, from 7:00 a.m. to 8:00 a.m. (EDT), in Washington, DC.
“The opportunity to showcase evidence supporting the unique design of WRAPSODY will be an important aspect for broader adoption of its use,” said Dr. Balamuthusamy. “I look forward to presenting this evidence for colleagues who will attend CiDA.”
“The ability to present findings from the WAVE study is an important accomplishment for us. It is a significant step in our steadfast commitment to provide clinically meaningful improvements to physicians striving to better the lives of patients undergoing hemodialysis,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We are pleased with the progress achieved in recent months toward our regulatory strategy for WRAPSODY in the United States, and we look forward to engaging with the FDA as it reviews our PMA application for this innovative technology.”
The Merit WRAPSODY Cell-Impermeable Endoprosthesis is not approved, cleared, or available for commercial distribution in the United States and may not be approved, cleared, or available for sale or use in other countries. In the United States, the device is being used under an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA). Findings from the WAVE study are expected to expand on results from the first-in-human study (WRAPSODY FIRST) and support the Premarket Approval (PMA) application to the FDA for commercial use in the United States. WRAPSODY previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil. For additional information on Merit’s WAVE study, please visit https://clinicaltrials.gov/study/NCT04540302.
ABOUT MERIT MEDICAL
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable 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 700 individuals. Merit employs approximately 7,000 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
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