Amplifi Vascular has been granted breakthrough device designation by the US Food and Drug Administration (FDA) and category B assignment from the Centers for Medicare & Medicaid Services (CMS) for the Amplifi vein dilation system.
The Amplifi system is designed to enhance vein size and quality prior to arteriovenous fistula (AVF) creation, enabling more durable, reliable dialysis access and supporting the shift toward earlier, safer cannulation.
Breakthrough device designation is granted to technologies that offer a potentially more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.
“This coveted breakthrough device designation reflects the innovative work already completed at Amplifi Vascular, inclusive of a robust first-in-human data from 19 patients, and also strategically positions us for accelerated development and patient access,” said Sean Morris, the company’s chief executive officer.
“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.”
