Amplifi Vascular, Inc. has received Breakthrough Device Designation along with a Category B assignment from the Centers for Medicare and Medicaid Services for its Amplifi Vein Dilation System. This milestone recognizes the company’s progress in advancing medical device innovation and represents an important step toward improving care for patients who rely on long-term dialysis access.

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Commenting on the achievement, Sean Morris, Chief Executive Officer of Amplifi Vascular, explained that the designation reflects both the strength of the technology and the quality of the clinical evidence generated to date. He noted that early human data from nineteen patients played a critical role in earning this recognition and positions the company to move more efficiently through development. Morris emphasized that closer and more frequent engagement with the Food and Drug Administration, combined with the CMS Category B assignment, is expected to help shorten the path to market while improving access for patients who depend on reliable dialysis solutions. He also highlighted that the company has already incorporated health economics considerations into its clinical study planning to support future coverage discussions.

The Breakthrough Device Designation is reserved for technologies that demonstrate the potential to provide more effective treatment or diagnosis for serious or life-threatening conditions. It is awarded only when strict criteria are met, signaling meaningful advancement over existing options. In Amplifi Vascular’s case, the submission was supported by a comprehensive clinical data package, including first-in-human results that demonstrated promising outcomes and helped validate the system’s potential impact.

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With this designation, Amplifi Vascular gains the opportunity for enhanced collaboration with the FDA throughout the regulatory process. This closer interaction can help streamline development and review timelines, potentially bringing new treatment options to patients sooner. The accompanying Category B assignment from CMS further signals recognition of the technology’s potential value in clinical care and its relevance to future reimbursement and patient access considerations.

Amplifi Vascular is focused on developing medical devices that improve outcomes in hemodialysis vascular access. Its Amplifi Vein Dilation System is designed to significantly improve vein size and quality prior to arteriovenous fistula creation, supporting more durable and dependable dialysis access. By enabling earlier and safer cannulation, the company aims to address a critical need for patients requiring long-term, life-sustaining dialysis therapy.

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