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
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 decision summary (DEN230002).
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. PubMed 31866081 · doi:10.1016/j.jtcvs.2019.10.115
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 was found during the study.
Caliskan E, Sandner S, Misfeld M, et al. Protocol and rationale for the European, multicentre, prospective, observational DuraGraft registry. J Cardiothorac Surg. 2019;14(1):174. PubMed 31615560 · NCT02922088
Caliskan E, Sandner S, Misfeld M, et al. Protocol and rationale for the European, multicentre, prospective, observational DuraGraft registry. J Cardiothorac Surg. 2019;14(1):174. PubMed 31615560 · NCT02922088
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).
Caliskan E, Misfeld M, Sandner S, et al. Transatlantic analysis of patient profiles and mid-term survival after isolated CABG: European DuraGraft Registry vs US STS Registry. Front Cardiovasc Med. 2024;11:1366460. PubMed 39346099 · Free full text
Caliskan E, Misfeld M, Sandner S, et al. Transatlantic analysis of patient profiles and mid-term survival after isolated CABG: European DuraGraft Registry vs US STS Registry. Front Cardiovasc Med. 2024;11:1366460. PubMed 39346099 · Free full text
This analysis is observational and does not establish causation.