24-Month Clinical Results For Healionics' Stargraft Featured At Cida Conference
STARgraft is intended to provide kidney failure patients with a safer and more reliable means to access the bloodstream for dialysis treatment. It is designed to resist the two most common causes of failure in on-market AV grafts: occlusion (flow blockage) and infection.
In its latest clinical trial, STARgraft showed remarkable promise in addressing both issues and reducing the need for interventions to maintain graft function. STARgraft maintained 100% Primary Unassisted Patency (PUP) through 12 months post-implant (meaning zero interventions were required to maintain sufficient blood flow for dialysis therapy) and 80% PUP through 24 months. STARgraft also maintained a 0% infection rate through 24 months.
These results contrast sharply with the poor outcomes of on-market AV grafts, which have a PUP of just 41% at 12 months and 28% at 24 months, and infection rates of 9% per year (Halbert et al., 2020 ).
Clinical evidence of STARgraft's mechanism of action was also presented at CiDA.
“On-market grafts fail at high rates after they stiffen with time due to constriction effects from scar tissue encapsulation,” commented Healionics founding CTO Andrew Marshall.“STARgraft is the first vascular graft demonstrated to maintain long-term flexibility in the graft wall and connected outflow vein, and we are pleased to present clinical evidence supporting this novel mechanism of action.”
About Dialysis and Vascular Grafts
More than 550,000 people in the United States 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 are risky, unreliable and costly, driving a significant portion of the $50 billion the U.S. spends each year to treat kidney failure. An arteriovenous vascular graft (synthetic blood vessel) 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 vascular graft, based on proprietary synthetic biomaterial technology, is designed to resist both problems.
STARgraft is an investigational device not yet available for commercial sale.
About Healionics Corp.
Healionics is a privately held medical device company in Seattle that aims to improve the health, longevity, and quality of life of kidney failure patients while reducing treatment cost. 
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