Healionics’ STARgraft Receives FDA Breakthrough Device Designation
SEATTLE, WA, UNITED STATES, November 14, 2024 /EINPresswire.com/ — Healionics Corporation, a developer of synthetic biomaterial-based medical devices, today announced that its STARgraft arteriovenous graft – designed to provide a safer and more reliable means of bloodstream access for kidney failure patients needing dialysis – has been granted Breakthrough Device designation by the FDA. The FDA’s Breakthrough Devices Program aims to identify important new medical devices that provide more effective treatment of life-threatening and irreversibly debilitating conditions, and fast-tracks their regulatory review in order to provide timely access for patients and healthcare providers. This Breakthrough designation signifies FDA acknowledgment that STARgraft clinical outcomes show evidence of significant advantages over existing alternatives for dialysis access. The benefits of receiving Breakthrough designation include expedited interactions with FDA regarding market clearance and with Medicare regarding potential added reimbursement for healthcare providers.
