TRUE -Vascular Graft
Synthetic vascular grafts currently used in clinic have poor long term outcomes and low patency rates. Hyperplasia, calcification, foreign body immune response, infection, and atheroma formation are commonly encountered limiting the use of synthetic grafts, with none available for small diameter applications like coronary bypass.
TRUE™ Vascular Graft is 100% biological with no synthetic raw materials. Through our quality controlled manufacturing process, TRUE™ graft with diameters in range from 3.0 to 25.0 mm are developed to match anatomical sites.
Extensive preclinical in vivo testing conducted by Vascudyne™ and the University of Minnesota in sheep and baboons have been published in peer-reviewed journals. These studies have demonstrated that TRUE™ Vascular Grafts are:
- Non-calcific
- Long-term patency
- Regenerative with proven recellularization and remodeling
- Mechanical properties comparable to native blood vessels
- Elicit negligible immune/foreign body response
- Able to adapt and grow with the graft recipient
TRUE™ Vascular Grafts are completely cell-derived matrix, decellularized after in vitro bioreactor culture, sterilized, and stored for off-the-shelf use. Recellularization and regeneration take place after implantation by the host cells with organized cell and matrix composition.
TRUE™ Vascular Graft technology is well suited for several anatomical sites:
- Arteriovenous grafts
- Coronary bypass
- Peripheral bypass
- Diabetic vascular repair
- Trauma repair
HEMODIALYSIS GRAFT
Successful First-In-Human use of TRUE Graft as a hemodialysis graft was performed in end-stage renal disease patients. Preliminary post-implantation results showed excellent flow and normal healing.
TRUE Graft has the potential to provide a much-needed long term solution for hemodialysis patients based on preclinical studies. Previous results from a preclinical baboon model showed that 12-cm long grafts were completely regenerated and endothelialized after 6 months post-implantation (Syedain et al, 2017).
CORONARY ARTERY BYPASS GRAFT
TRUE Graft with the ability to regenerate, recellularize and function like native blood vessel provides an ideal long-term solution for small diameter CABG applications. A 4mm TRUE Graft implanted in a sheep heart as coronary artery bypass from aorta to left interior descending (LAD) artery shows excellent graft functionality in the angiogram below.