Merit Medical Achieves Milestone with WRAP North America Registry

Introduction to the WRAP North America Registry

A significant milestone has been reached with the successful enrollment of the first patient in the WRAP North America registry, a prospective, multicenter initiative led by Merit Medical Systems, Inc. (NASDAQ: MMSI). This registry is designed to gather comprehensive data on the safety and effectiveness of the WRAPSODY Cell-Impermeable Endoprosthesis (CIE), specifically aimed at improving hemodialysis care for patients facing vascular access challenges.

Patient Enrollment Highlights

The inaugural patient was enrolled at Bluff City Vascular, a renowned center specializing in interventional nephrology and vascular access. This pivotal moment marks the beginning of a study intended to include up to 250 patients from both the US and Canada who are undergoing hemodialysis and experiencing vascular obstructions, such as stenosis or occlusion.

Impact on Hemodialysis

Patients on hemodialysis often face serious complications due to obstructed veins, which can significantly hinder their treatment. The WRAPSODY CIE aims to combat these issues by restoring effective vascular access, allowing for uninterrupted dialysis procedures. The study anticipates evaluating clinical outcomes related to the use of the WRAPSODY CIE over a substantial three-year period, providing invaluable data to enhance the quality of care.

Expert Insights

Omar Davis, MD, the President and Medical Director at Bluff City Vascular, shared his enthusiasm regarding the new device: "We appreciate the ingenuity and novelty of the WRAPSODY CIE. Participation in this registry is crucial as it allows us to assess the device's impact on optimizing hemodialysis care for our patients." This sentiment is echoed by other medical professionals involved in the study, underscoring the potential of the WRAPSODY CIE.

Previous Clinical Evidence

The WRAPSODY CIE has already shown promise in clinical trials, notably the WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial, which illustrated its efficacy compared to traditional treatment methods. In this trial, patients were treated either with the WRAPSODY CIE or with standard percutaneous transluminal angioplasty (PTA). The results indicated a favorable outcome for those receiving the WRAPSODY device, paving the way for its adoption in routine clinical practice.

Future of Vascular Access Restoration

David J. Dexter II, MD, FACS, serves as the National Principal Investigator for the registry and highlights the importance of this initiative: "The WRAPSODY CIE’s ability to restore vascular access is indeed promising. Assessing its real-world effectiveness through this registry will address crucial questions about its broader implications for clinical practice." Merit Medical aims to enhance its evidence base with this study, potentially establishing the largest group of patients treated with an implantable device for vascular access restoration in hemodialysis.

Broader Studies: WRAP Global Registry

In addition to the North America registry, Merit Medical is conducting the WRAP Global registry, aiming to gather data from up to 500 patients outside North America. This broader study is expected to conclude in the near future, further contributing to global data on the device’s effectiveness and applicability in various populations.

Company Commitment to Innovation

Fred P. Lampropoulos, Chairman and CEO of Merit Medical, emphasized the importance of this milestone: "The enrollment of the first patient in the WRAP North America registry is vital for our ongoing pursuit of high-quality evidence regarding the WRAPSODY CIE’s performance. We are proud to contribute to advancements in technology that improve patient care and support our physician partners in enhancing the future of dialysis treatments."

Furthermore, the WRAPSODY CIE has achieved significant regulatory milestones. Earlier approvals include the premarket approval from the US Food and Drug Administration (FDA) and Health Canada, alongside securing the CE mark for commercial use in the European Union and availability in Brazil. These achievements demonstrate the device's global recognition and potential impact.

Conclusion

As Merit Medical continues its commitment to providing innovative medical devices, the WRAP North America registry represents a crucial step towards enhancing patient care in hemodialysis. The insights gained from this study will play a vital role in shaping treatment protocols and ultimately improving the lives of patients reliant on these critical procedures.

Frequently Asked Questions

What is the WRAP North America registry?

The WRAP North America registry is a prospective, multicenter study aimed at collecting real-world data on the safety and effectiveness of the WRAPSODY Cell-Impermeable Endoprosthesis in patients undergoing hemodialysis.

Who enrolled the first patient in the study?

The first patient was enrolled by Omar Davis, MD, at Bluff City Vascular, a center specializing in interventional nephrology.

How many patients will be involved in the registry?

The registry aims to include up to 250 patients from the US and Canada who experience vascular access issues related to hemodialysis.

What outcomes will the registry evaluate?

The registry will evaluate clinical outcomes associated with the use of the WRAPSODY CIE over a three-year period, focusing on the restoration of vascular access in hemodialysis patients.

What are the next steps for the WRAPSODY CIE?

Merit Medical is committed to advancing this technology and conducting further studies, including the WRAP Global registry, to better understand the device’s effectiveness across diverse patient populations.

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