The approval for CollaFix surgical mesh CD, which is a Class III product in Europe, was issued by the company’s notified body, AMTAC Certification Services.
MiMedx chairman and CEO Parker ‘Pete’ Petit said the certification is the first of many in a line of products using the company’s CollaFix technologies to resemble the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair.
”Our collagen fibers, that are the size of human hair, are fabricated in continuous lengths and have similar strength and stiffness to human tendons. The fibers are bio-compatible and resorbable,” Petit added.
The company said CollaFix surgical mesh CD has not yet cleared for use in the US.
