Merit Medical’s WRAPSODY WAVE Trial Exceeds Performance Goals for Arteriovenous Graft (AVG) Patients
Merit Medical Systems (NASDAQ: MMSI) announced positive six-month results from the single-arm AVG cohort of its WRAPSODY WAVE pivotal trial. The trial, involving 112 patients across 43 international sites, demonstrated 82% target lesion primary patency and 68.8% access circuit primary patency at six months. The WRAPSODY device achieved an efficacy rate of 81.4%, significantly exceeding the performance goal of 60% (p<0.0001). Safety outcomes were also favorable, with 95.4% of patients free from adverse events, surpassing the 89% performance goal (p=0.0162). The WRAPSODY Cell-Impermeable Endoprosthesis is designed to restore vessel access in hemodialysis patients and is currently available in Brazil and the European Union, pending FDA approval in the US.
Merit Medical Systems (NASDAQ: MMSI) ha annunciato risultati positivi a sei mesi dal braccio a singolo gruppo della coorte AVG del suo trial pivotale WRAPSODY WAVE. Lo studio, che ha coinvolto 112 pazienti in 43 siti internazionali, ha dimostrato una patente primaria della lesione target dell'82% e una patente primaria del circuito di accesso del 68,8% a sei mesi. Il dispositivo WRAPSODY ha raggiunto un tasso di efficacia dell'81,4%, superando significativamente l'obiettivo di prestazione del 60% (p<0,0001). Anche i risultati di sicurezza sono stati favorevoli, con il 95,4% dei pazienti privi di eventi avversi, oltrepassando l'obiettivo di prestazione dell'89% (p=0,0162). L'Endoprotesi Cell-Impenetrabile WRAPSODY è progettata per ripristinare l'accesso ai vasi nei pazienti in emodialisi ed è attualmente disponibile in Brasile e nell'Unione Europea, in attesa dell'approvazione della FDA negli Stati Uniti.
Merit Medical Systems (NASDAQ: MMSI) anunció resultados positivos a seis meses del grupo de un solo brazo de la cohorte AVG de su ensayo pivotal WRAPSODY WAVE. El ensayo, que involucró a 112 pacientes en 43 sitios internacionales, demostró una patencia primaria de la lesión objetivo del 82% y una patencia primaria del circuito de acceso del 68,8% a los seis meses. El dispositivo WRAPSODY logró una tasa de eficacia del 81,4%, superando significativamente el objetivo de rendimiento del 60% (p<0,0001). Los resultados de seguridad también fueron favorables, con el 95,4% de los pacientes libres de eventos adversos, superando el objetivo de rendimiento del 89% (p=0,0162). La Endoprótesis Celular Impermeable WRAPSODY está diseñada para restaurar el acceso a los vasos en pacientes en hemodiálisis y actualmente está disponible en Brasil y en la Unión Europea, a la espera de la aprobación de la FDA en los EE. UU.
메릿 메디컬 시스템즈 (NASDAQ: MMSI)는 WRAPSODY WAVE 주요 시험의 단일 그룹 AVG 코호트에서 6개월 긍정적인 결과를 발표했습니다. 43개 국제 사이트에서 112명의 환자가 참여한 이 시험은 82% 목표 병변 1차 개통율과 68.8% 접근 회로 1차 개통율을 6개월에 걸쳐 보여주었습니다. WRAPSODY 장치는 81.4%의 효능률을 달성하여 60%의 성능 목표(p<0.0001)를 크게 초과했습니다. 안전성 결과 또한 좋았으며, 95.4%의 환자가 부작용으로부터 자유로운 것으로 나타나 89%의 성능 목표를 초과했습니다(p=0.0162). WRAPSODY 세포 불침투성 내프로테시스는 혈액투석 환자의 혈관 접근을 회복하도록 설계되었으며, 현재 브라질과 유럽연합에서 사용 가능하며 미국에서는 FDA 승인을 기다리고 있습니다.
Merit Medical Systems (NASDAQ: MMSI) a annoncé des résultats positifs après six mois de l'essai pivot WRAPSODY WAVE dans le cadre d'un groupe unique AVG. L'essai, qui a impliqué 112 patients sur 43 sites internationaux, a démontré une patence primaire de la lésion cible de 82% et une patence primaire du circuit d'accès de 68,8% après six mois. Le dispositif WRAPSODY a atteint un taux d'efficacité de 81,4%, dépassant largement l'objectif de performance de 60% (p<0,0001). Les résultats de sécurité ont également été favorables, avec 95,4% des patients exempts d'événements indésirables, dépassant l'objectif de performance de 89% (p=0,0162). L'endoprothèse cellulaire imperméable WRAPSODY est conçue pour restaurer l'accès vasculaire chez les patients en hémodialyse et est actuellement disponible au Brésil et dans l'Union européenne, en attente de l'approbation de la FDA aux États-Unis.
Merit Medical Systems (NASDAQ: MMSI) hat positive sechsmonatige Ergebnisse aus der einarmigen AVG-Kohorte seiner wegweisenden Studie WRAPSODY WAVE bekannt gegeben. In der Studie, die 112 Patienten an 43 internationalen Standorten umfasste, wurde eine primäre Patente der Zielläsion von 82% und eine primäre Patente des Zugangskreislaufs von 68,8% nach sechs Monaten nachgewiesen. Das WRAPSODY-Gerät erreichte eine Wirksamkeitsrate von 81,4% und übertraf damit deutlich das Leistungsziel von 60% (p<0,0001). Auch die Sicherheitsresultate waren positiv, da 95,4% der Patienten frei von unerwünschten Ereignissen waren und das Leistungsziel von 89% (p=0,0162) übertrafen. Die WRAPSODY zellundurchlässige Endoprothese ist dafür konzipiert, den Gefäßzugang bei Hämodialysepatienten wiederherzustellen und ist derzeit in Brasilien und der Europäischen Union erhältlich, während die FDA-Zulassung in den USA noch aussteht.
- Achieved 82% target lesion primary patency at six months
- Efficacy rate of 81.4%, exceeding performance goal by 21.4 percentage points
- 95.4% of patients were free from adverse events, surpassing safety goal
- Already commercially available in Brazil and European Union
- Product not yet approved for commercial distribution in the United States
- Still requires FDA Premarket Approval (PMA)
Insights
The WAVE trial results represent a significant breakthrough in hemodialysis access management. The 82% target lesion primary patency and 68.8% access circuit primary patency at 6 months substantially exceed historical benchmarks. The efficacy rate of
The safety profile is equally impressive, with
This clinical trial success significantly strengthens Merit Medical's position in the lucrative hemodialysis market. With WRAPSODY already approved in Brazil and the EU, these positive results support the pending FDA PMA application, potentially opening up the important US market. The exceptional efficacy and safety data could drive strong market adoption and reimbursement coverage.
The global hemodialysis access market represents a substantial opportunity, with recurring revenue potential due to the chronic nature of dialysis treatment. These results could translate into meaningful revenue growth for Merit Medical, particularly given their expanding portfolio in this therapeutic area.
WRAPSODY achieves
SOUTH JORDAN, Utah, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced positive six-month findings from the single-arm AVG cohort of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The data were presented at the 51st annual VEITHsymposium during the Novel Technologies in Hemodialysis Access session.
An AVG is a synthetic tube that is used for long-term access to blood vessels for patients undergoing hemodialysis. However, over time, the graft may become narrow or blocked, resulting in potentially life-threatening consequences. Merit’s WRAPSODY Cell-Impermeable Endoprosthesis is designed to restore and extend vessel access (patency) in hemodialysis patients, which is critical for patient survival.
The WAVE trial was designed to evaluate the efficacy and safety of the WRAPSODY device. The AVG arm of the WAVE trial enrolled 112 patients across 43 international sites. All enrolled patients were treated with the WRAPSODY device. Based on survival analysis through six months, target lesion and access circuit primary patency for AVG patients in the WAVE trial were
“In light of the historically low patency rates for AVG patients, the positive results from the AVG arm of the WAVE trial are very encouraging for physicians who manage these patients,” said Mahmood K. Razavi, MD, FSIR, FSVM, Interventional Radiologist and Medical Director of Clinical Research at St. Joseph Heart and Vascular Center in Orange, Calif., and Co-Principal Investigator of the WAVE trial.
“The patency results from the WAVE trial are the highest that I have seen to date and are expected to meaningfully improve patients’ quality of life and vascular access survival,” said Leonardo Harduin, MSc, Vascular Surgeon at University of Rio de Janeiro State in Rio de Janeiro, Brazil, and an Investigator of the WAVE trial. “These results will probably have a positive impact on costs related to the care of these patients.”
“At Merit, we remain committed to continued collaboration with our physician partners to improve care for hemodialysis patients. Over the past year we have expanded our product offering and focus on these patients. The WRAPSODY device is an important part of this growing portfolio,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We are pleased to have the opportunity to share the favorable primary outcomes from the WAVE trial at VEITHsymposium.”
The Merit WRAPSODY Cell-Impermeable Endoprosthesis is not approved or available for commercial distribution in the United States and may not be approved 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 trial expand on results from the first-in-human trial (WRAPSODY FIRST) and support the Premarket Approval (PMA) application to the FDA for commercial use in the United States. The device is available in Brazil and in the European Union. For additional information on Merit Medical’s WAVE trial, please visit: https://clinicaltrials.gov/ct2/show/NCT04540302.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Statements contained in this release which are not purely historical, including, without limitation, statements regarding anticipated results, outcomes and applications of clinical trials, studies and investigations involving Merit’s products, safety, efficacy and patient and physician adoption of Merit’s products, Merit’s ability to procure and maintain required regulatory approvals for its products, forecasted plans, revenues and other operating and financial measures, or future growth and profit expectations or forecasted economic conditions, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to risks and uncertainties such as those described in Merit’s Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Annual Report”) and other filings with the US Securities and Exchange Commission (the “SEC”). Such risks and uncertainties include inherent risks and uncertainties related to the safety, efficacy and patient and physician adoption of Merit’s products, the ability to fully enroll and the final results and outcomes of clinical trials and studies involving the Merit’s products, the ability to obtain and maintain reimbursement codes for Merit’s products, Merit’s ability to procure and maintain required regulatory approvals for its products; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; difficulties, delays and expenditures relating to development, testing and regulatory approval or clearance of Merit’s products, including the pursuit of approvals under the European Union Medical Device Regulation, and risks that such products may not be developed successfully or approved for commercial use; potential for significant adverse changes in governing regulations, including reforms to the procedures for approval or clearance of Merit’s products by the US Food & Drug Administration or comparable regulatory authorities in other jurisdictions; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; changes in healthcare policies or markets related to healthcare reform initiatives; and other factors referenced in the 2023 Annual Report and other materials filed with the SEC.
All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. All forward-looking statements included in this release are made only as of the date of this release, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to estimates and all other forward-looking statements.
ABOUT MERIT MEDICAL
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 700 individuals. Merit employs approximately 7,200 people worldwide.
ABOUT VEITHSYMPOSIUM
Now in its 51st year, VEITHsymposium provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The five-day event features rapid-fire presentations from world renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques. Contact Pauline T. Mayer at 631.807.6335 or ptm@ptmhcm.com for additional information.
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Merit Medical
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1 The primary efficacy outcome was defined as the proportion of patients free from clinically driven target lesion revascularization or target lesion thrombosis through six months.
2 The primary safety outcome was the proportion of patients without any localized or systemic adverse events in the 30 days following treatment that negatively affected the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis).
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