Cardiac

Allograft Solutions for Cardiac Procedures

The CardioGraft® portfolio of cryopreserved and decellularized allografts offers surgeons a safe and reliable solution for cardiac repair and reconstruction. Human allografts have shown to have a natural resistance to infection and can be used directly in infected surgical fields. For patients who present with an infection or those who are susceptible to infection, a cardiac allograft may be the safest choice for cardiac repair and reconstruction.^1-6

Aortic & Pulmonary Valve Replacement

Allograft aortic valves are effective for replacing infected native and prosthetic valves, as allograft tissue is naturally resistant to infection. Allograft pulmonary valves are ideal for adult congenital RVOT reconstruction and pediatric valve replacement. Both valve types allow patients to live actively without the burden of lifelong anticoagulation therapies.

Conduit Repair & Reconstruction

Allograft conduits are proven solutions for cardiac repair and reconstruction. They are also effective against graft infections as allografts are naturally resistant to infections.

Congential Defect Repair

Allograft patch grafts are utilized in repair of the right ventricular outflow tract and congenital outflow tract anomalies. Patch grafts are available both cryopreserved and decellularized utilizing our patented Matracell technology.

^{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

5. Lofland GK, et al. Initial pediatric cardiac experience with decellularized allograft patches. Ann of Thoracic Surg, 2012;93:968-71

6. Hopkins RA, et al. Pulmonary Arterioplasty With Decellularized Allogeneic Patches. Ann of Thoracic Surg, Vol. 97, Issue 4, April 2014, Pages 1407-1412}

68-60-151_aortic_valve.pdf

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

Cryopreserved	Description	Size
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

68-60-150_pulmonary_valve.pdf

Description

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

Natural ability to resist infection^1,2,3
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

Clinical Application

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

Cryopreserved	Description	Size
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

68-60-153_ascending_aorta_conduit.pdf

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

Cryopreserved	Description	Size
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

68-60-152_pulmonary_conduit.pdf

Description

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

Natural ability to resist infection^1,2,3
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

Cryopreserved	Description	Size
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

68-60-154_thoracic_aorta.pdf

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.

Clinical Application

Infected Descending Aorta; Conduit Repair; Extra Cardiac Shunt
Aorta Reconstruction

Cryopreserved	Description	Size
TAS	Thoracic Aorta	D ≤ 16 mm
TAM	Thoracic Aorta	D = 17 - 21 mm
TAL	Thoracic Aorta	D ≥ 22 mm

68-60-156_hemi-pulmonary_artery.pdf

Description

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

Natural ability to resist infection^1,2,3
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

Clinical Application

Tetralogy of Fallot, Pulmonary Atresia, Outflow Tract/Root Reconstruction, Truncus Arteriosus, Transposition of Great Vessels, Hypoplastic Left Heart Syndrome, Pulmonary Stenosis/Atresia

68-60-159_mono_cusp_patch.pdf

Description

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

Natural ability to resist infection^1,2,3
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

Cryopreserved	Description	Size
MCPL	Mono Cusp Patch	≥ 22 mm

68-60-155_pulmonary_patch_graft.pdf

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

Cryopreserved	Description	Size
PPGN	Thin (Branch)	W = 2.5 - 5 cm; L = 3 - 8 cm
PPGK	Thick (Trunk)	W = 2.5 - 5 cm; L = 3 - 8 cm

68-60-158_decell_pulmonary_patch.pdf

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 intervention^1,2
Patented, validated decellularization and disinfection process that removes ≥99% of donor DNA³
Resists calcification and stenosis^1,2
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

Frozen	Description	Size
DPPGN	Thin (Branch)	W = 2.5 - 5 cm; L = 3 - 8 cm
DPPGK	Thick (Trunk)	W = 2.5 - 5 cm; L = 3 - 8 cm

68-60-157_decell_hemi_pulm_artery.pdf

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 intervention^1,2
Patented, validated decellularization and disinfection process that removes ≥99% of donor DNA³
Resists calcification and stenosis^1,2
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

Frozen	Description	Size
DRHPA	Right	Multiple options, varies by donor
DLHPA	Left	Multiple options, varies by donor

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Cardiac

Aortic & Pulmonary Valve Replacement

Conduit Repair & Reconstruction

Congential Defect Repair

Cardiac

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Cardiac

Aortic & Pulmonary Valve Replacement

Conduit Repair & Reconstruction

Congential Defect Repair

Cardiac