News | Congenital Heart | June 30, 2016

CorMatrix Cardiovascular Treats First Patients with Tyke Product for Neonates and Infants

Extracellular matrix now an alternative for congenital heart defect repairs in smaller structures

Cormatrix Cardiovascular, Tyke ECM, extracellular matrix, neonates and infants

June 30, 2016 — CorMatrix Cardiovascular Inc. 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 U.S. Food and Drug Administration (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 two layers of CorMatrix ECM (extracellular matrix) as compared to the four layers of the current CorMatrix ECM for Cardiac Tissue Repair, therefore providing a thinner product for smaller repairs.

Frank Scholl, M.D., chief, pediatric and congenital heart surgery and surgical director, pediatric heart transplant, and Steven Bibevski, M.D., pediatric and congenital cardiac surgeon, both at Joe DiMaggio Children’s Hospital in Hollywood, Fla., 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).

Scholl noted, “The availability of Tyke and its two-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. 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

For more information: www.cormatrix.com

Related Content

Videos | Congenital Heart | November 01, 2018
Example of GE Healthcare’s FetalHQ software for the ultrasound imaging of fetal hearts.
Cardiac Ultrasound Software Streamlines Fetal Heart Exams
Feature | Congenital Heart | October 30, 2018
A new tool called fetalHQ on GE Healthcare’s Voluson ultrasound systems is the first tool to simultaneously examine the...
St. Louis Children's and Washington University Heart Center Perform Rare Infant Heart-Lung Transplant

Image courtesy of St. Louis Children's and Washington University Heart Center

News | Congenital Heart | September 25, 2018
Five-month-old Jack Palmer is home with his family in Kansas City after undergoing an extremely rare heart-lung...
New Research Explores Role of Gene Mutation in Congenital Heart Defects
News | Congenital Heart | June 18, 2018
June 18, 2018 — Heart defects are the most common type of birth defect, and can be caused by mutations in the gene CH
Global Study Examines Therapy for Patients with Single-Ventricle Cardiac Defect

Image courtesy of Hayek Medical

News | Congenital Heart | May 02, 2018
Select adult patients born with a single functioning ventricle, and who have undergone a surgical operation called the...
Infant Heart Defects May Predict Late-Life Heart Problems in Birth Mother
News | Congenital Heart | April 12, 2018
Women who give birth to infants with congenital heart defects may have an increased risk of cardiovascular...
Bariatric Surgery May Help Prevent Premature Heart Disease for Severely Obese Teens
News | Congenital Heart | March 30, 2018
March 30, 2018 — Bariatric surgery is predicted to cut in half the...
Videos | Congenital Heart | March 20, 2018
A discussion with Ami Bhatt, M.D., director of the adult...
Stem Cell Therapy May Offer Treatment for Rare Congenital Cardiac Defect
News | Congenital Heart | February 05, 2018
February 5, 2018 — Children's Hospital Los Angeles announced participation in the first-ever...
Screening for Critical Congenital Heart Disease at Birth Saves Lives
News | Congenital Heart | December 05, 2017
Infant deaths from critical congenital heart disease (CCHD) decreased more than 33 percent in eight states that...
Overlay Init