Today CorMatrix® Cardiovascular, Inc. announced receiving FDA approval to expand and enroll 20 additional patients in the adult arm, including up to 4 additional cardiac surgery research and investigative centers, for its early feasibility IDE study of the Cor® TRICUSPID ECM® valve* for pediatric and adult patients. The Cor® TRICUSPID ECM® valve has been successfully implanted in the 11th patient enrolled in the expansion by Dr. Marc Gerdisch, Chief of Cardiothoracic Surgery at Franciscan Health Heart Center in Indianapolis, Indiana & principal investigator for the adult component of the study. The Cor® TRICUSPID ECM® valve is a next-generation, first of its kind, biologic, seamless, and stentless cardiac valve composed of extracellular matrix or ECM®.
“The most recent implant of the CorMatrix Cor® TRICUSPID valve represents an important step toward realizing an implantable, regenerating tissue-engineered heart valve. We are now broadening the study to additional centers which will greatly increase our enrollment. So far the valves are performing very well, and patients are excited to be part of this important innovation,” said Dr. Marc W Gerdisch, Chief of Cardiothoracic Surgery at Franciscan Health Heart Center in Indianapolis, Indiana & principal investigator for the adult component of the CorMatrix® Cor® TRICUSPID IDE safety and feasibility clinical trial.
“CorMatrix® is very excited to expand enrollment of the adult arm of its FDA early feasibility IDE study for the Cor® TRICUSPID ECM® valve. This is just one step closer to ultimately providing biologic valve technology to an ever-expanding patient need. The Cor® TRICUSPID ECM® valve is the first of its kind that provides a new treatment option. As a result, we are very pleased to receive the approval from the FDA to expand the number of study patients and centers,” said Edgar Rey, President & CEO, CorMatrix® Cardiovascular, Inc.
*Cor® TRICUSPID ECM® valve is an investigational device and not commercially available.