The FDA has cleared Atlanta-based CorMatrix Cardiovascular's CorMatrix ECM for carotid repair, which uses the company's proprietary ECM Technology.
The ECM technology is an extracellular matrix biomaterial that provides a natural bio-scaffold enabling a patient's host cells to repair damaged tissues. CorMatrix has an exclusive license from Purdue University to research, develop, manufacture and market ECM products for cardiovascular applications. It has FDA clearance and CE Mark approval for its ECM technology as an implant for pericardial closure and for use in cardiac tissue repair.
CorMatrix ECM has been used at more than 300 hospitals across the U.S. and implanted in roughly 20,000 cardiac procedures since its launch in 2006, according to the company's website.
"We believe the unique properties of our CorMatrix material provide a new and vital alternative to current approaches in carotid artery repair. Having received numerous inquires from the clinical surgery community for a CorMatrix product to address this clinical need, we were very pleased with the timely manner in which FDA reviewed and cleared this submission," said David Camp, chairman and CEO of CorMatrix, in a statement.
Privately held CorMatrix was incorporated in December 2001 by Camp, an executive in the cardiovascular medical device field, and Robert Matheny, a cardiothoracic surgeon and co-inventor on several patents related to ECM technology.
- check out the CorMatrix release