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Merit Medical wins FDA Breakthrough Device Designation for WRAPSODY system


Merit WRAPSODY endovascular stent graft system has almost completed its ‘First in Man’ studies, and is not currently commercialised


Merit Medical secures FDA Breakthrough Device Designation for Wrapsody (Credit: Pixabay)

Merit Medical Systems has secured the US Food and Drug Administration (FDA) Breakthrough Device Designation for its WRAPSODY endovascular stent graft system.

For the Wrapsody system, which is a flexible, self-expanding endoprosthesis, the company plans to seek an indication for use in hemodialysis patients for the treatment of stenosis within the central veins of the outflow circuit of an arteriovenous fistula (AVF) up to the superior vena cava.

Merit Medical chairman and CEO Fred P Lampropoulos said: “We are pleased with the recognition by the FDA of this worthwhile technology as well as the efforts of many members of our R&D team to bring the project to this point. Most importantly, we believe this system will provide substantial benefits to patients who may be treated with it in the future.”

Merit Wrapsody system is a flexible, self-expanding endoprosthesis

The company said that its Wrapsody endovascular stent graft system has almost completed its ‘First in Man’ studies, and is not currently commercialised.

In August 2019, Merit announced the commercial launch of its PreludeSYNC EVO radial compression device in the US. PreludeSYNC EVO is a sterile, single-use, disposable device designed to help in achieving haemostasis of the arterial percutaneous access site following catheterization procedures.

The company said that its redial compression device was designed to provide improved clarity, safety, and patient comfort, and features new Slip-n-Lock Connection for safe and easy inflation and deflation.

Also, the design of the device with a clear balloon and curved backer plate offers optimal visualization of the puncture site, and facilitates easy placement.

Established in 1987, Merit Medical Systems, develops, manufactures and distributes disposable medical devices for 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 300 individuals. Merit employs approximately 6,350 people worldwide with multiple facilities across the US, and in different countries around the world.