CorMatrix® Cardiovascular, Inc. receives FDA approval to expand and enroll 20 additional patients in the adult arm of its early feasibility IDE study of the Cor® TRICUSPID ECM® valve for pediatric and adult patients
ATLANTA, Feb. 7, 2020 /PRNewswire/ -- CorMatrix(®)Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today 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.
CorMatrix(®) Cardiovascular, Inc. is a regenerative biotechnology company based in metro Atlanta, Georgia. A pioneer and leader in regenerative science and technology, the company was founded to address congestive heart failure, the largest global disease management challenge and unmet cardiovascular clinical need. CorMatrix(® )provides regenerative, technological innovations, and patient solutions for the treatment of congestive heart failure and other cardiovascular diseases. The company is committed to developing innovative future non-synthetic, regenerative devices for the cardiovascular system through continued research and improvements to the CorMatrix(® )ECM(® )technology.
*Cor(®) TRICUSPID ECM(®) valve is an investigational device and not commercially available.
For more information, please contact Edgar Rey, President & CEO at erey@cormatrix.com or visit www.cormatrix.com
Media contact: Edgar Rey, 404-285-0466
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SOURCE CorMatrix® Cardiovascular, Inc.
