CRESSKILL, N.J., Nov. 12, 2008 (GLOBE NEWSWIRE) -- Vascular Therapies LLC, a combination product company, recently announced encouraging safety and efficacy data from the company's First-in-Man study wherein the COLL-R membrane (a sirolimus eluting biodegradable collagen membrane) was implanted at the PTFE graft venous anastomotic site.
Dr. William Paulson, Professor of Medicine at the Medical College of Georgia, presented a study entitled "Safety And Efficacy Of Locally Eluted Sirolimus For Prolonging AV Graft Patency (PTFE Graft Plus COLL-R) - First In Man Experience" at the recent American Society of Nephrology's 41st Annual Meeting in Philadelphia, Pennsylvania. In this small study, the primary endpoint was safety. Key secondary endpoints included technical success of COLL-R membrane implantation, as well as pharmacokinetics of sirolimus release, and primary unassisted graft patency.
During 24 months of follow-up, there were no adverse events related to use of the COLL-R membrane. The technical success rate was 100% and there were no infections or wound or vascular complications. Primary unassisted AV graft patencies at 12 and 24 months were 75% and 38%, respectively. Dr. Paulson remarked "AV Graft patency rates in this cohort are encouraging when compared with historical controls."
Mr. Sam Liang, President and CEO of Vascular Therapies, added: "These First-In-Man results suggest that the use of the COLL-R membrane may offer a significant patency benefit for hemodialysis AV graft patients. Vascular Therapies is preparing to initiate pivotal trials in the U.S. and Europe to further establish the safety and efficacy of the COLL-R membrane in hemodialysis and other applications."
About Hemodialysis Access
The United States Renal Data System (USRDS) reported that in 2006, a total of 506,256 patients had End-Stage Renal Disease (ESRD) and 327,754 patients were undergoing hemodialysis. The USRDS projects that approximately 784,613 patients will have ESRD by 2020.
Vascular access failure in the hemodialysis population is a problem of major importance. One-year primary unassisted patency for AV grafts ranges from only 23 to 43%. The cause of most AV graft failures is neointimal hyperplasia, which results in stenosis at the graft-venous anastomosis and graft thrombosis. The expense of creating and maintaining vascular accesses is estimated to be more than a billion dollars per year. At the present time, there are no proven or approved treatments for prevention or reduction of neointimal hyperplasia at the site of the graft vascular anastomosis.
About Vascular Therapies, LLC
Vascular Therapies is a vascular product company whose innovative research and development has led to the creation of a drug eluting combination product platform technology, the COLL-R membrane.