Healionics Corporation has today announced that its STARgraft arteriovenous graft—which it states is 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 US Food and Drug Administration (FDA).
The US 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 US 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 the US FDA regarding market clearance and with Medicare regarding potential added reimbursement for healthcare providers.
According to the press release issued earlier today, more than 550,000 people in the USA suffer from kidney failure and require frequent dialysis to filter waste from their blood. Current methods of creating and maintaining regular bloodstream access for dialysis, Healionics argues, are risky, unreliable and costly, driving a significant portion of the US$50 billion the USA spends each year to treat kidney failure. They added that an arteriovenous graft (AVG) is often implanted to create an access site with sufficient flow rate for dialysis, but existing grafts frequently fail due to occlusion and/or infection. Healionics’ innovative STARgraft arteriovenous graft, based on proprietary synthetic biomaterial technology, is designed to resist both problems.
Healionics chief executive officer (CEO) Mike Connolly shared his thoughts on this Breakthrough designation, stating: “US FDA recognition of STARgraft’s potential to significantly improve the standard of care and quality of life for dialysis patients is a major company milestone and validation of our team’s efforts.”
