The addition of Tyke to the CorMatrix product line is our commitment to help surgeons improve the lives of our smallest patients.
The CorMatrix® Tyke® was developed from a request by Pediatric Cardiovascular Surgeons to deliver an ECM material that maintained the biomechanical properties found in our existing products, but was thinner, more pliable and better suited for intracardiac and branch pulmonary artery use in neonates and infants.
The Tyke is intended for use in neonates and infants for repair of pericardial structures, as an epicardial covering for damaged or repaired cardiac structures, as a patch material for intracardiac defects, septal defect and annulus repair, suture-line buttressing, and cardiac repair. CorMatrix Tyke meets the same biomechanical requirements (tensile strength, suture retention strength and burst strength) as our existing CorMatrix ECM for Cardiac Tissue Repair.
Since its launch in 2006, CorMatrix ECM has been implanted in over 145,000 cardiovascular procedures including pediatric congenital heart defect repairs. These implants include septal defect repair, valve repair, aortic arch reconstruction, superior vena cava (SVC) repair, right ventricular outflow tract (RVOT) and pulmonary artery repair, pericardial closure and suture line buttressing. The review of publications used in this report show a 96% freedom from failure* when CorMatrix ECM is used for pediatric repairs. The most common form of failure was stenosis after pulmonary artery repair, followed by regurgitation after CorMatrix was used for valve repair. (See Figures 1 and 2). 1, 2, 3, 4, 5
* Failure in this summary is defined as any patient who required surgical or catheter based intervention.
Pulmonary Artery Stenosis
When implanted, there is a natural influx of cells to CorMatrix ECM during the remodeling phase. This does not pose a problem for larger vessel repair but can result in a transient stenosis of small branch pulmonary arteries (PA). In the literature reviewed, it’s important to note that most of the cases of PA stenosis were amenable to balloon or stent intervention. A newer 2-ply product, CorMatrix Tyke , is now available and was developed to meet the need for a thinner material that is more pliable and better suited for small branch pulmonary artery repair.2
Successful remodeling of CorMatrix ECM depends on the viability of the native tissue surrounding the implant. In cases of leaflet repair, there have been reports of regurgitation, lack of remodeling, and inflammation. The majority of these failures have occurred when a free edge was exposed or when CorMatrix was sewn to dysplastic tissue versus a repair where CorMatrix was surrounded by healthy, viable tissue.2
CorMatrix conducted rigorous internal assessments to evaluate the bio-mechanical properties of our new Tyke product. With respect to mechanical properties, bench testing has shown that Tyke exceeds the specified tensile strength, suture retention strength, and burst strength required for its intended surgical use. To assess the biological performance of the CorMatrix Tyke, patches were implanted in the descending aorta and pulmonary artery of a growing lamb model.
Explanted patches were evaluated by an independent, board-certified pathologist. The CorMatrix Tyke was found to restore the structural integrity (including the formation of a mature, stable, and fully endothelialized neointima) of the implant site within 90 days (Figure 1). By 180 days, the thickness of the remodeled CorMatrix Tyke patch was similar to the thickness of the adjacent native artery.
Referenced articles used for this review:
1 Woo et. al. Histologic examination of decellularized porcine intestinal submucosa extracellular matrix (CorMatrix) in pediatric congenital heart surgery. Cardiovasc Pathol. 2016; 25:12-7.
2 Padalino, MA et al. Early and mid-term clinical experience with extracellular matrix scaffold for congenital cardiac and vascular reconstructive surgery: a multicentric Italian study. Interact CardioVasc Thorac Surg 2015; 21:40-49.
3 Witt RG et al. Short-term experience of porcine small intestinal submucosa patches in paediatric cardiovascular surgery. Eur J Cardiothorac Surg. 2013; 44:72-6.
4 Harvey E, Roselli EE, Pettersson G, Idrees J, Stewart R. Use of Extracellular Matrix for Repair of Congenital Defects in Pediatric Patients. Paper presented at: 62nd Annual Meeting of the Southern Thoracic Surgical Association (STSA); 2015 Nov 4-7; Lake Buena Vista, Florida.
5 Fernandez-Doblas J et. al. Correction of Congenital Cardiac Defects with CorMatrix Extracellular Matrix in Pediatric Patients: Is it Really Safe?; Rev Esp Cardiology.2016 Aug; 69(8): 787-9.