Amplifi Vascular Inc. has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation and Category B assignment from the Centers for Medicare & Medicaid Services (CMS) for the Amplifi Vein Dilation System.

“This Breakthrough Device Designation reflects the work already completed at Amplifi Vascular, inclusive of first-in-human data from 19 patients, and also strategically positions us for accelerated development and patient access,” Amplifi Vascular CEO Sean Morris said. “The ability to engage frequently and efficiently with the FDA, coupled with the Category B assignment from CMS, will significantly streamline our path to market, ultimately benefiting patients in need of life-sustaining dialysis access. With an eye towards market access, we have taken important early steps towards establishing a relationship with CMS and have included important healthcare economics in the context of our clinical study design.”

The Breakthrough Device Designation is a distinction reserved for technologies that offer a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. This status is not easily attained; rather, it is granted exclusively to companies whose innovations meet stringent criteria, reflecting a substantial leap forward in medical science. Amplifi Vascular’s data set, which included compelling first-in-human results from patients, was a key factor in securing this designation, according to the company.

This Breakthrough Device designation provides Amplifi Vascular with opportunities for more frequent and efficient FDA interactions. Such enhanced collaboration can streamline the development and review processes, potentially accelerating the availability of important new therapies to those who need them most. The concurrent Category B assignment from CMS further acknowledges the potential impact of the company’s advancements on future patient access and coverage.

This recognition underscores several key aspects of Amplifi Vascular’s commitment to innovation:

• Rigorous Selection: The Breakthrough Device Designation is awarded to companies with innovations that address unmet medical needs for serious conditions, signifying a high level of scientific merit.
• Clinical Validation: The designation was supported by a robust, complete data set, which included initial human study results that provided a solid foundation for its potential.
• Streamlined Development: This recognition facilitates closer and more productive engagement with the FDA, potentially speeding up regulatory pathways and bringing solutions to patients sooner.
• CMS Recognition: The accompanying Category B assignment from CMS highlights the potential for future coverage and patient access, indicating a broader understanding of the technology’s value.

Amplifi Vascular is a medical device company developing solutions to improve outcomes in hemodialysis vascular access. The Amplifi Vein Dilation System is designed to dramatically enhance vein size and quality prior to AVF creation, enabling more durable, reliable dialysis access and supporting the shift toward earlier, safer cannulation.