ROSWELL, Ga.--(BUSINESS WIRE)--CorMatrix Cardiovascular, Inc., a leading developer of biomaterials and medical devices, today announced the treatment of the first patients using its CorMatrix® Tyke®, a product specifically designed and cleared for cardiac tissue repairs in neonates and infants. The product received FDA 510(k) clearance in February 2016. CorMatrix® 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 defects and annulus repair, suture-line buttressing, and cardiac repair. Tyke® is made of 2 layers of CorMatrix® ECM® as compared to the 4 layers of the current CorMatrix® ECM® for Cardiac Tissue Repair, therefore providing a thinner product for smaller repairs.
Dr. Frank Scholl, Chief, Pediatric & Congenital Heart Surgery and Surgical Director, Pediatric Heart Transplant and Dr. Steven Bibevski, Pediatric & Congenital Cardiac Surgeon, both at Joe DiMaggio Children’s Hospital in Hollywood, FL were the first to implant the CorMatrix® Tyke® ECM® device. The company is implementing a phased commercial launch of the device involving approximately 20 pediatric centers who will be trained and certified to receive the device. Tyke™ was developed as an alternative to synthetic grafts or patches, and for complex reconstructive surgeries in neonates and infants with congenital heart defects (CHD).
Dr. Scholl noted, “The availability of Tyke and its 2 ply construction will allow us the ability to repair the tiniest structures in the most delicate and tiniest of newborn babies, and achieve a more accurate—and hopefully—more durable repair. We are excited about the future Tyke provides for our most fragile patients.”
The American Academy of Pediatrics and the Congenital Heart Public Health Consortium (CHPHC) estimates congenital heart defects are the most common birth defects. Nearly 1 of every 100 babies is born with a CHD and each year, approximately 40,000 babies are born in the United States with a congenital heart defect. [Source: CHPHC]. Most CHD-related surgical procedures require the use of prosthetic material for reconstruction of intracardiac and extra cardiac structures. Several different biological and prosthetic materials are commonly used in surgery including autologous pericardium, preserved homograft, bovine pericardium, and polytetrafluoroethylene. None of these alternatives represents the ideal prosthetic tissue, which should be pliable and easy to handle, resistant to calcification or shrinkage. Most importantly, it should have growth potential and should not induce formation of scar tissue.¹
Andrew Green, President and Chief Operating Officer commented, “We are excited to partner with our pediatric cardiac surgeons to deliver Tyke as product developed to address a specific need in the neonatal and infant population. CorMatrix Tyke is one of the few products commercially available that is specifically designed and labeled for the treatment of neonate and infant cardiac tissue repair.”
CorMatrix® Cardiovascular, Inc. is a privately held medical device company dedicated to developing and delivering innovative biomaterial devices that harness the body’s own innate ability to repair damaged cardiac and vascular tissues. CorMatrix® ECM® Technology allows surgeons to restore the native anatomy of cardiac and vascular tissue in need of repair, serving as a superior alternative to synthetic or cross-linked materials. Headquartered in Roswell, Georgia, the Company is currently researching, developing and commercializing a platform technology known as CorMatrix® ECM® for a variety of cardiovascular and other indications, and has U.S. clearance and European registration (with a CE Mark) for its ECM® technology. Since its launch in 2006, CorMatrix® ECM® Technology has been used at more than 975 hospitals across the U.S. and has been implanted in over 145,000 cardiac procedures. Visit cormatrix.com for additional information.
¹ Preliminary Experience with Cardiac Reconstruction Using Decellularized Porcine Extracellular Matrix Scaffold: Human Applications in Congenital Heart Disease Frank G. Scholl, MD¹, Mark M. Boucek, MD¹, Kak-Chen Chan, MD, MBBS¹, Lilliam Valdes-Cruz, MD¹, and Richard Perryman, MD¹ World Journal for Pediatric and Congenital Heart Surgery