Sirogen™ is a novel bio-resorbable collagen-based drug delivery system. Vascular Therapies is evaluating local (perivascular) delivery of sirolimus, which starts intra-operatively soon after the surgical creation of the vascular access is successfully completed.
The lipophilic sirolimus molecule combines with the lipid elements in the wall of the blood vessel and reduces (down regulates) cellular proliferation, a known effect of the drug when delivered to the vessel wall. Tissue pharmacokinetic studies in animal model pre-clinical studies show persistence of drug sirolimus for at least eight weeks after the surgical implant commencement of drug delivery.
The collagen delivery system is designed to maintain its cylindrical shape without the need for sutures and to permit the expected increase in vein diameter – an integral part of fistula maturation.
Approximately 80% of patients in the United States initiate dialysis with a catheter. These patients will continue to be catheter-dependent until a fistula (or an AV graft) becomes ready for dialysis.
Increasing the proportion of fistulae that can be used for successful hemodialysis is one of the important clinical goals for Sirogen™. Additionally, reducing the time between surgery and when the fistula can be used, cannulated successfully for dialysis and minimizing the need for supplementary interventions to help maintain fistula functionality are extremely clinically relevant outcomes. Achieving these endpoints are expected to reduce catheter dwell time and catheter dependence – a much-desired outcome with important implications for patients, dialysis providers and payors.