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CardioCel Bioscaffold

CardioCel Neo Bioscaffold

CardioCel 3D 30° Bioscaffold

CardioCel 3D 60° Bioscaffold

CardioCel® Bioscaffold

Acellular, Strong, Pliable Collagen Bioscaffold

Product Information

CardioCel is an acellular, strong, pliable collagen bioscaffold with optimized biocompatibility and zero aldehyde toxicity. The collagen bioscaffold allows for transformative repair with harmonious healing, providing long-term durability that enables native cells to successfully grow and differentiate through the entire repair.

Key Benefits
CardioCel & CardioCel Neo Bioscaffold
CardioCel 3D Bioscaffold
References
Models & Specs

Require fewer interventions(1)
Have the largest published data over the longest timeframe(1)
Are the first and only to offer 3D bioscaffold
Improve hospital efficiencies overall(1)

Offered in three versions to address your specific surgical needs:

CardioCel - for heart repair and reconstruction

CardioCel Neo - for more intricate procedures

CardioCel 3D - shaped for great vessel repair

Restorative Structural Heart Repair and Reconstruction

Unique Intraoperative Benefits and Procedural Efficacies

Ready to use off the shelf; No thawing, rinsing or preparation required
Elasticity virtually identical to human aortic valve leaflet(4)
Stronger than the human aorta(4)
The only bioscaffold with unparalleled calcium resistance(3)

Optimized clinical performance

No antigenic or immunogenic stimulus(3,4,5)
No calcium binding sites(3,4)
No glutaraldehyde toxicity(4)
Terminally sterilized for reduced risk of infection- SAL 10^-6 (2)
Proven native cell integration(3,4,5)

Enhanced procedural efficiency

Easy to suture, trim
Enhanced pliability
Readily conforms to repair site
Excellent hemostasis - resists suture line bleeding(9)

CardioCel Neo Bioscaffold

CardioCel Neo has all the benefits of CardioCel but is refined to 0.3 mm thickness for the most intricate procedures.

Surgical Applications
Pericardial closure
Repair of cardiac and vascular defects including intracardiac defects
Septal defects, valve and annulus repair
Great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing

All the Benefits of CardioCel Optimally Shaped for Great Vessel Repair

Shape Matters: CardioCel 3D 60°

Curved bioscaffold enables Roman Arch shaped reconstruction
Roman Arch shape optimizes hemodynamics(6,7,8)
Anisotropy which matches that of native aortic tissue in both circumferential and longitudinal tissue planes(10)

Growing evidence shows that shape matters in complex repair(1-8)

Gothic arch morphology derangements and mismatched dimensions are associated with poorer outcomes, including:

Indexed End-Diastolic Volume
Hypertension
Intimal hyperplasia
Cavopulmonary pressure


Surgical Applications
Hypoplastic aortic arch (HAA)
Interrupted aortic arch (IAA)
Pulmonary artery (PA)
Right ventricular outflow tract (RVOT) - Hood and TAP
Baffle

(1) Bell, Douglas, et. al. Multi-centre experience with 500 CardioCel® implants used for the repair of congenital heart defects. The Annals of Thoracic Surgery. 2019; S0003-4975(19)30843-4.

(2) AAMI/ISO 117337-2: Sterilization of medical devices — Microbiological methods, Part 2: Tests of sterility performed in the validation of a sterilization process.

(3) Brizard, CP, et al. New Engineering treatment of bovine pericardium confers outstanding resistance to calcification in mitral and pulmonary implantations in a juvenile sheep model. The Journal of Thoracic and Cardiovascular Surgery. 2014; 148:3194-3201.

(4) Neethling, WM, et al. Enhanced biostability and biocompatibility of decellularized bovine pericardium, crosslinked with an ultra-low concentration monomeric aldehyde and treated with ADAPT. The Journal of Heart Valve Disease. 2008; 17:456-463; discussion 464.

(5) Prabhu, S., JE Armes, D. Bell, R. Justo, P. Venugopal, T. Karl, and N. Alphonso. Histologic Evaluation of Explanted Tissue-Engineered Bovine Pericardium (CardioCel). Seminars in Thoracic and Cardiovascular Surgery. 2017; 29(3):356-363.

(6) Bruse JL, Cervi E, McLeod K, et al. Looks do matter! Aortic arch shape after hypoplastic left heart syndrome palliation correlates with cavopulmonary outcomes. The Annals of Thoracic Surgery. 2017;103:645-654.

(7) Itatani K, Miyaji K, Qian Y, et al. Influence of surgical arch reconstruction methods on single ventricle workload in the Norwood procedure. The Journal of Thoracic and Cardiovascular Surgery. 2012;144:130-138.

(8) SeoD-M, Park J, Goo HW, Kim YH, KoJ-K, JhangWK. Surgical modification for preventing a gothic arch after aortic arch repair without the use of foreign material. Interactive CardioVasular and Thoracic Surgery 2015;20:504–9.

(9) Neethling, WM, et al. Evaluation of a tissue-engineered bovine pericardial patch in paediatric patients with congenital cardiac anomalies: initial experience with the ADAPT-treated CardioCel® patch. Interactive CardioVascular and Thoracic Surgery 2013;1–5.

(10) Data on file.

USA & Canada