Cardiac

Allograft Bio-Implants for Cardiac Procedures

Suitable for a wide variety of complex congenital heart defects, as well as for adults with extensive valvular disease. The CardioGRAFT® line of tissue grafts offers heart valves, repair grafts, conduits and decellularized tissue grafts with Matracell® decellularization technology.

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Description

CardioGraft® Aortic Valve
A human aortic valve for aortic valve replacement

  • Allograft tissue most closely resembles the patient’s native tissue
  • The use of human tissue alleviates the need for anticoagulants
  • Effective orifice area closely approximates the native valve
  • Anterior mitral leaflet retained for use in endocarditis/abscess reconstruction
  • Availability in various sizes to best fit the patient’s anatomy
  • Safety: Allografts offer a high resistance to infection

 


References

1. Hopkins. Cardiac Reconstructions with Allograft Tissues. Springer, NY, NY. 2005
2. Fukushima, Tesar, et al. Long-term clinical outcomes after aortic valve replacement using cryopreserved aortic allograft. Journal of Thoracic and Cardiovascular Surgery, 2014; 148, 1: 65-72.
3. Lytle, Pettersson, et al. Reoperative cryopreserved root and ascending aorta replacement for acute aortic prosthetic valve endocarditis. The Annals of Thoracic Surgery, 2002; 74: 1754-1757.
4. Pettersson, Coselli, et al. 2016 The American Association for Thoracic Surgery (AATS) consensus guidelines: Surgical treatment of infective endocarditis. Journal of Thoracic and Cardiovascular Surgery, 2017; 153: 1241-1258.

 

Clinical Application

Aortic Valve Replacement

CryopreservedDescriptionSize
HVA-S

Aortic Heart Valve

D ≤ 16 mm
HVA-M

Aortic Heart Valve

D = 17 - 21 mm
HVA-L

Aortic Heart Valve

D ≥ 22 mm
Description

CardioGraft® Pulmonary Valve
Cryopreserved human pulmonary valve for pulmonary valve replacement

  • Natural ability to resist infection1,2,3
  • Alleviates the need for anticoagulation therapy4
  • Reduced thrombosis potential3
  • Allografts most closely resemble native tissue, making them compliant, flexible and easy to handle

 


 

References

1. Kirklin et al. Aortic Valve Endocarditis with Aortic Root Abscess Cavity: Surgical Treatment with Aortic Valve Homograft. Ann Thorac Surg 45:674-677, June 1988
2. Tuna et al. Results of Homograft Aortic Valve Replacement for Active Endocarditis. Ann Thorac Surg 1990; 49: 619-24
3. Hopkins et al. Cardiac Reconstructions with Allograft Tissues. Springer 2005
4. Pettersson, Coselli, et al. 2016 The American Association for Thoracic Surgery (AATS) consensus guidelines: Surgical treatment of infective endocarditis. Journal of Thoracic and Cardiovascular Surgery, 2017; 153: 1241-1258
Clinical Application

Tetralogy of Fallot, Pulmonary Stenosis, Infective Endocarditis, Ross Procedure, Valve Regurgitation, Valve Atresia

CryopreservedDescriptionSize
HVP-S

Pulmonary Heart Valve

D ≤ 16 mm
HVP-M

Pulmonary Heart Valve

D = 17 - 21 mm
HVP-L

Pulmonary Heart Valve

D ≥ 22 mm
Description

CardioGraft® Ascending Aorta Conduit (non-valved)
A human ascending aorta (leaflets excised) for aorta reconstruction

  • Allograft tissue most closely resembles the patient’s native tissue
  • Easy to handle and suture
  • Safety: Allografts offer a high resistance to infection

 


References

1. Philpott and Zemlin. Aortic reconstruction for an infected stent graft with a composite homograft. Journal of Thoracic and Cardiovascular Surgery, 2017; 153, 5: e73-75.
2. Lytle, Pettersson, et al. Reoperative cryopreserved root and ascending aorta replacement for acute aortic prosthetic valve endocarditis. The Annals of Thoracic Surgery, 2002; 74: 1754-1757.
3. Preventza, Coselli, et al. Homograft use in reoperative aortic root and proximal aortic surgery for endocarditis: A 12-year experience in high-risk patients. Journal of Thoracic and Cardiovascular Surgery, 2014; 148: 989-994.
Clinical Application
  • Aorta Reconstruction
CryopreservedDescriptionSize
AAS

Ascending Aorta (non-valved)

D ≤ 16 mm
AAM

Ascending Aorta (non-valved)

D = 17 - 21 mm
AAL

Ascending Aorta (non-valved)

D ≥ 22 mm
Description

CardioGraft® Pulmonary Artery (non valved)
Cryopreserved human pulmonary artery conduit with no leaflets used for pulmonary reconstruction

  • Natural ability to resist infection1,2,3
  • Alleviates the need for anticoagulation therapy4
  • Reduced thrombosis potential3
  • Allografts most closely resemble native tissue, making them compliant, flexible and easy to handle
Clinical Application

Tetralogy of Fallot, Pulmonary Atresia, Truncus Arteriosis, Transposition of the Great Arteries

CryopreservedDescriptionSize
PAS

Pulmonary Artery (non-valved)

D ≤ 16 mm
PAM

Pulmonary Artery (non-valved)

D = 17 - 21 mm
PAL

Pulmonary Artery (non-valved)

D ≥ 22 mm
Description

CardioGraft® Thoracic Aorta Conduit
A human descending aorta

  • Allograft tissue most closely resembles the patient’s native tissue
  • Easy to handle and suture
  • Safety: Allografts offer a high resistance to infection

 


References

1. Philpott and Zemlin. Aortic reconstruction for an infected stent graft with a composite homograft. Journal of Thoracic and Cardiovascular Surgery, 2017; 153, 5: e73-75.
2. Lytle, Pettersson, et al. Reoperative cryopreserved root and ascending aorta replacement for acute aortic prosthetic valve endocarditis. The Annals of Thoracic Surgery, 2002; 74: 1754-1757.
3. Preventza, Coselli, et al. Homograft use in reoperative aortic root and proximal aortic surgery for endocarditis: A 12-year experience in high-risk patients. Journal of Thoracic and Cardiovascular Surgery, 2014; 148: 989-994.
Clinical Application
  • Infected Descending Aorta; Conduit Repair; Extra Cardiac Shunt
  • Aorta Reconstruction

 

CryopreservedDescriptionSize
TAS

Thoracic Aorta

D ≤ 16 mm
TAM

Thoracic Aorta

D = 17 - 21 mm
TAL

Thoracic Aorta

D ≥ 22 mm
Description

CardioGraft® Hemi-Pulmonary Artery (right or left)
Cryopreserved human pulmonary artery used for cardiac repair and reconstruction

  • Natural ability to resist infection1,2,3
  • Alleviates the need for anticoagulation therapy4
  • Reduced thrombosis potential3
  • Human tissue – Closely resembles autograft; compliant and flexible
  • Forgiving and compliant to the native tissue. Easy to handle and suture, saving time.

 


References

1. Kirklin et al. Aortic Valve Endocarditis with Aortic Root Abscess Cavity: Surgical Treatment with Aortic Valve Homograft. Ann Thorac Surg 45:674-677, June 1988
2. Tuna et al. Results of Homograft Aortic Valve Replacement for Active Endocarditis. Ann Thorac Surg 1990; 49: 619-24
3. Hopkins et al. Cardiac Reconstructions with Allograft Tissues. Springer 2005
4. Pettersson, Coselli, et al. 2016 The American Association for Thoracic Surgery (AATS) consensus guidelines: Surgical treatment of infective endocarditis. Journal of Thoracic and Cardiovascular Surgery, 2017; 153: 1241-1258
Clinical Application
Tetralogy of Fallot, Pulmonary Atresia, Outflow Tract/Root Reconstruction, Truncus Arteriosus, Transposition of Great Vessels, Hypoplastic Left Heart Syndrome, Pulmonary Stenosis/Atresia
DescriptionSize
RHPARight Hemi-Pulmonary ArteryVaries
LHPALeft Hemi-Pulmonary ArteryVaries
Description

CardioGraft® Mono Cusp Patch
Cryopreserved human pulmonary artery trunk with single leaflet used for cardiac repair and reconstruction

  • Natural ability to resist infection1,2,3
  • Alleviates the need for anticoagulation therapy4
  • Reduced thrombosis potential3
  • Allografts most closely resemble native tissue, making them compliant, flexible and easy to handle

 


References

1. Kirklin et al. Aortic Valve Endocarditis with Aortic Root Abscess Cavity: Surgical Treatment with Aortic Valve
Homograft. Ann Thorac Surg 45:674-677, June 1988
2. Tuna et al. Results of Homograft Aortic Valve Replacement for Active Endocarditis. Ann Thorac Surg 1990; 49: 619-24
3. Hopkins et al. Cardiac Reconstructions with Allograft Tissues. Springer 2005
4. Pettersson, Coselli, et al. 2016 The American Association for Thoracic Surgery (AATS) consensus guidelines:
Surgical treatment of infective endocarditis. Journal of Thoracic and Cardiovascular Surgery, 2017; 153: 1241-1258
Clinical Application
Tetralogy of Fallot, Pulmonary Atresia and Stenosis, Outflow Tract/Root Reconstruction procedures as a single leaflet valve
CryopreservedDescriptionSize
MCPL

Mono Cusp Patch

≥ 22 mm
Description
CardioGraft® Pulmonary Patch Graft (Thick & Thin)
A human pulmonary artery patch graft for cardiac outflow tract repair and reconstruction
  • Allograft tissue most closely resembles the patient’s native tissue
  • Allografts are an alternative for patients lacking available autologous tissue
  • Easy to handle and suture
  • Safety: Allografts offer a high resistance to infection

 


Reference

1. Hopkins. Cardiac Reconstructions with Allograft Tissues. Springer, NY, NY. 2005

Clinical Application

Right side/pulmonary reconstructions, Tetralogy of Fallot, Hypoplastic Left Heart Syndrome, Truncus arterious, Transposition of the Great Vessels

CryopreservedDescriptionSize
PPGN

Thin (Branch)

W = 2.5 - 5 cm; L = 3 - 8 cm
PPGK

Thick (Trunk)

W = 2.5 - 5 cm; L = 3 - 8 cm
Description
CardioGraft-MC® Decellularized Pulmonary Patch Graft
Decellularized human pulmonary patch used for right side cardiac repair and reconstruction
  • Clinical effectiveness – lower potential for reoperation or intervention1,2
  • Patented, validated decellularization and disinfection process that removes ≥99% of donor DNA3
  • Resists calcification and stenosis1,2
  • Allografts most closely resemble native tissue, making them compliant, flexible and easy to handle
  • Potentially reduces operating room time and cost by reducing the rate of serious adverse events and
    reoperations4

References

1. Lofland GK, et al. Initial pediatric cardiac experience with decellularized allograft patches. Ann of Thoracic Surg, 2012;93:968-71
2. Hopkins RA, et al. Pulmonary Arterioplasty With Decellularized Allogeneic Patches. Ann of Thoracic Surg, Vol. 97, Issue 4, April 2014, Pages 1407-1412
3. LifeNet Health data on file: PQ-07-078
4. CardioGraft-MC (also known as Matracell®) Decellularized Cardiac Patch Allograft Cost-Effectiveness Analysis
Musculoskeletal Clinical Regulatory Advisors, June 2014
Clinical Application
Repair of the right ventricular outflow tract for Tetralogy of Fallot, Truncus Arteriosis, Hypoplastic Left Heart Syndrome, Transposition of the Great Arteries, Pulmonary Stenosis/Atresia
FrozenDescriptionSize
DPPGN

Thin (Branch)

W = 2.5 - 5 cm; L = 3 - 8 cm
DPPGK

Thick (Trunk)

W = 2.5 - 5 cm; L = 3 - 8 cm
Description
CardioGraft-MC® Decellularized Hemi-Pulmonary Artery (right or left)
Decellularized human pulmonary artery used for cardiac repair and reconstruction
  • Clinical effectiveness – lower potential for reoperation or intervention1,2
  • Patented, validated decellularization and disinfection process that removes ≥99% of donor DNA3
  • Resists calcification and stenosis1,2
  • Allografts most closely resemble native tissue, making them compliant, flexible and easy to handle
  • Potentially reduces operating room time and cost by reducing the rate of serious adverse events and reoperations4

References
1. Lofland GK, et al. Initial pediatric cardiac experience with decellularized allograft patches. Ann of Thoracic Surg, 2012;93:968-71
2. Hopkins RA, et al. Pulmonary Arterioplasty With Decellularized Allogeneic Patches. Ann of Thoracic Surg, Vol. 97, Issue 4, April 2014, Pages 1407-1412
3. LifeNet Health data on file: PQ-07-078
4. CardioGraft-MC (also known as Matracell®) Decellularized Cardiac Patch Allograft Cost-Effectiveness Analysis Musculoskeletal Clinical Regulatory Advisors, June 2014
Clinical Application
Repair of the right ventricular outflow tract for Tetralogy of Fallot, Truncus Arteriosis, Hypoplastic Left Heart Syndrome, Transposition of the Great Arteries, Pulmonary Stenosis/Atresia
FrozenDescriptionSize
DRHPA

Right

Multiple options, varies by donor
DLHPA

Left 

Multiple options, varies by donor