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The SynerGraft® Advantage

What is it?

SynerGraft is CryoLife’s patented decellularization technology that serves as the foundation for the next generation of implantable biological tissues.

The SynerGraft Process
The SynerGraft Process

The Value

It is important to avoid elevated Panel Reactive Antibodies (PRA) in patients receiving SynerGraft cardiac tissue as some may ultimately require a heart transplant. While the link between immune response and allograft tissue performance is still being debated, there is evidence that an elevated PRA poses a significant risk to future organ transplant patients.

 

PRA Results-SynerGraft Process Vs Standard Process
Class I Alloantibodies After Implant

PRA Results-SynerGraft Process Vs Standard Process Class I Alloantibodies After Implant
PRA Results-SynerGraft Process Vs Standard Process Class I Alloantibodies After Implant

Features and Benefits

  • Excellent Durability9
  • Optimal Hemodynamics10
  • Increase Freedom From Pulmonary Insufficiency*,11
  • Virtually Eliminates the Presence of Allogenic Donor Cells12
  • Maintains Structural Integrity of the Biological Matrix13
  • No Need for Anticoagulation

*Compared to Standard Cryopreserved Allograft.

SynerGraft vs. The Competition

Differentiating Factors SynerGraft
Tissue		 Other Tissue
Processors
Proven To Reduce Panel Reactive Antibodies In Patients* Yes No
> 5,700 Documented Decellularized Tissues Implanted Since 2000 Yes Unknown
Four Stage Microbiological Testing on Every Tissue Yes Unknown
Long-Term Human Clinical Data
(495 pts, 3.6 years mean follow-up, mean 23.2 years, total pt years 1769.1)3		 Yes No
Detergent-Free Decellularization Process
(Detergents may damage structural proteins)4-8		 Yes No
5 Year Shelf Life Yes No
Available on valves, hemi-arteries and patches Yes No

* Implantation of the SynerGraft treated pulmonary cardiac tissue reduces the risk for induction of HLA class I and class II alloantibodies based on PRA measured at up to one year, compared to the standard processed pulmonary cardiac tissue. Data has not been provided to evaluate the effect of reduced HLA class I and class II alloantibodies on the long-term durability, or long-term resistance to rejection by the patient.

References

  1. Elkins R, et al. Ann Thorac Surg 2001; 71: S428-32.
  2. Gerson C, et al. Cryobiology 2011; 64: 33-42
  3. CryoLife, Inc. data on file, including interim data collected from the CryoValve SG post clearance study through 12.31.2011.
  4. Zhou J, et al. Biomaterials 2010; 31: 2549-2554.
  5. Booth C, et al. Journal of Heart Vasc Disease 2002; 11:457-462.
  6. Korossis S, et al. Journal of Heart Vasc Disease 2002; 11: 463-471.
  7. Hedman K, et al. Journal Cell Biology 1979; 81:83-91.
  8. Yang M, et al. J Biomed Mater Res Part B: Appl Biomater 2009; 91B:354-361.
  9. Ruzmetov M, et al. J Thorac Cardiovasc Surg 2012; 143:543-9.
  10. Brown JW, et al. J Thorac Cardiovasc Surg 2009; 139:339-348.
  11. Bibevski S, et al. Ann Thorac Surg 2017; 103:869-875.
  12. Elkins R, et al. Decellularized Human Valve Allografts. Ann Thorac Surg 2001; 71: S428-32.
  13. Gerson C, et al. Circulation 2011; 64:33-42.

Cardiac Allografts