SynerGraft Pulmonary Valve

CryoValve® SynerGraft Pulmonary Human Heart Valve Is the First and Only Decellularized Human Heart Valve to Receive 510(k) Clearance From the US Food and Drug Administration.

SynerGraft is CryoLife’s patented process that virtually eliminates the presence of donor cells while maintaining the functionality and shape of the biological matrix.1,2 The SynerGraft process allows the donated pulmonary valve to be free of the donor’s cells without damaging the valve itself. The SynerGraft process removes over 99% of donor cells from the elements of the tissue matrix (see Figure 1).3

Figure 1

CryoValve Without SynerGraft Processing

CryoValve® Leaflet Without SynerGraft Processing

CryoValve After SynerGraft Processing

CryoValve SG Leaflet After SynerGraft Processing

The SynerGraft Decellularization Process – How Are the Donor Cells Eliminated?

As can be seen in the first image, a donor tissue is received with living donor cells. The SynerGraft process eliminates those cells by enlarging the cell to the point of disintegration (step 1), and also breaks down the DNA of the cells (step 2). This process results in a pulmonary valve virtually free of donor cells (step 3).

Step 1: Hypotonic Lysis

 

Hypotonic Lysis

 

The cardiac allograft is placed in a hypotonic solution, causing the cells to lyse (disintegrate). Lysis exposes the membrane and intercellular material to degradation.

Step 2: Nuclease Digestion

 

DNA breaking up

 

The cardiac allograft is placed in a solution of enzymes designed to break down DNA and RNA genetic material.

Step 3: Sequential Washing

 

Cardiac Muscle end

 

The allograft goes through a series of washes to remove the cellular debris.

SynerGraft Benefits

*Compared to Standard Cryopreserved Allograft

CryoValve® SG Pulmonary Human Heart Valve has not been approved for use as a medical device by Health Canada, and nothing on this website is intended to promote its use in Canada.

References:

  1. Elkins R, et al. Decellularized Human Valve Allografts. Ann Thorac Surg 2001; 71: S428-32.
  2. Gerson C, et al. Circulation 2011; 64:33-42.
  3. CryoLife, Inc. data on file, including interim data collected from the CryoValve SG Post Clearance study through 12.31.2012.
  4. Ruzmetov M, et al. J Thorac Cardiovasc Surg 2012; 143:543-9.
  5. Brown JW, et al. J Thorac Cardiovasc Surg 2009; 139:339-348.
  6. Bibevski S, et al. Ann Thorac Surg 2017; 103:869-875.