Improving vascular access by reducing surgical stenosis
A functional, lasting vascular access with good blood flow is the lifeline for hemodialysis patients
there are currently three access options for hemodialysis:
To create an arteriovenous graft, one end of a synthetic (usually PTFE) graft is anastomosed to an artery and the other end is anastomosed to a vein. Approximately 3-4 weeks post-surgery, the PTFE graft can be cannulated for hemodialysis. Although AV grafts offer an alternative to fistula for patients with small or weak veins, it increases the risk of blood clotting, aneurysms, and infections.
Today in the U.S., approximately 80% of incident patients begin dialysis using a central venous catheter (CVC), the least preferred option. These patients will continue to be dialyzed using a catheter until a mature AV fistula or an AV graft is ready for insertion of needles to support dialysis. The use of catheters is associated with serious mortality and morbidity events that include infection, thrombosis and stenosis or occlusion of the central vein.
Stenosis is a major problem that threatens access
For AV fistula and av Grafts
UP TO 50% OF FISTULA require additional procedures or fail within 6-12 months
The failure is due primarily to a narrowing (stenosis) at the anastomosis and/or vein as a result of intimal hyperplasia.
[Ref: The Dialysis Access Consortium Studies (DAC)]
Sirogen™ is designed to prevent stenosis and ensure blood flow to support consistent dialysis
Designed to maintain its cylindrical shape without the need for sutures and permit the expected increase in vein diameter
A novel bioresorbable collagen-based drug delivery system
Applies a well-studied drug (sirolimus) to the blood vessel at and around the anastomosis which has been shown clinically to suppress the formation intimal hyperplasia
SEE HOW IT WORKS
Sirogen™ is a bioabsorbable implant that delivers a well-known drug called sirolimus to blood vessels. Sirolimus has been shown to keep blood vessels open. It is used in kidney transplant patients and with vascular devices to reduce blood vessel narrowing. During surgery to create the fistula, Sirogen™ is applied at the area of the fistula that is prone to narrowing.
Learn about the
The ACCESS 2 clinical study for patients 65 and older is determining if Sirogen can:
Increase the proportion of fistula that can be used for successful hemodialysis
Reduce the time between surgical creation of the fistula and when it can be used for hemodialysis
Reduce the proportion of fistula that are abandoned and require a new access
Achieving these endpoints is expected to reduce catheter dwell time and catheter dependence – a much-desired outcome with important implications for patients, dialysis providers, and payors.
ACCESS 2 Clinical Study