DURAGRAFT VASCULAR CONDUIT SOLUTION
The evidence behind DuraGraft.
Preclinical data, a prospective randomized trial, and real-world safety outcomes across 2,964 patients reviewed by the FDA
FDA De Novo Granted · Class II
PRECLINICAL EVIDENCE
Graft cell viability and structural integrity.
Human saphenous vein segments stored in DuraGraft maintained cell viability and endothelial morphology for up to 4 hours, compared with rapid loss of viability in saline-stored grafts.
Data from the FDA De Novo review (DEN230002). Refs 4, 7.n
Up to 4 hours
Cell viability and endothelial morphology maintained during intraoperative storage.
KEY FINDING AT 12 MONTHS
Vein grafts stored in DuraGraft showed 40% less wall thickness than saline-stored grafts in the same patient.
0.12 mm vs. 0.20 mm
p = 0.02
PROSPECTIVE RANDOMIZED TRIAL
Wall thickness assessment at 12 months.
Randomized, double-blind, 7-center study in which each patient’s grafts were compared head-to-head — DuraGraft-stored versus saline-stored — within the same patient. 125 patients, 250 grafts, assessed by MDCT angiography.
Perrault LP, Carrier M, Voisine P, et al. Sequential MDCT assessments after venous graft treatment solution in CABG. J Thorac Cardiovasc Surg. 2021;161(1):96-106.e2.
Note: Wall thickness is a biomarker. Its clinical significance as a surrogate for long-term graft patency has not been established.
2,964
Patients
Patients
45 Centers
8 Countries
DURAGRAFT EUROPEAN REGISTRY SAFETY PROFILE
Safety outcomes at 30 days and 1 year — including MACE, mortality, and revascularization — were consistent with published rates for contemporary CABG surgery. No evidence of any adverse events related to the DuraGraft Vascular Conduit Solution were found during the study.
REGISTRY COMPARISON, PROPENSITY-MATCHED MORTALITY ANALYSIS
2,400 DuraGraft EU Registry patients were compared with 2,400 propensity-matched STS registry patients. 36-month mortality was 7.37% in the DuraGraft group versus 9.65% in the matched comparison group (p=0.016).