CENTER FOR ADVANCED
REGENERATIVE ENGINEERING

Medical device created in CARE receives FDA clearance

Above: CITRELOCK tendon fixation devices. Credit: Acuitive Technologies

The Center for Advanced Regenerative Engineering, led by its director  Guillermo Ameer, has pioneered an innovative orthopedic medical device fabricated from a novel biomaterial, and has received clearance from the U.S. Food and Drug Administration (FDA) for use in surgeries to attach soft tissue grafts to bone.

The biomaterial is the first thermoset biodegradable synthetic polymer ever approved for use in an implantable medical device.  Ameer’s biomaterial, called CITREGEN™, helps grafted tissues heal by recreating their intrinsic biochemical and structural support network.CITREGEN is the core material technology in the CITRELOCK™ Interference Screw System, which will be produced and marketed by Acuitive Technologies, Inc. The system is intended for soft tissue attachment or fixing ligaments and tendon graft tissue in joint surgeries.  “CITREGEN is an unprecedented and innovative bioresorbable biomaterial technology developed to support the body’s normal healing process and promote tissue regeneration,” Ameer said. “When used to fabricate devices for reconstruction of tissues, such as ligaments, blood vessels, bladder and bone, results have been impressive and beyond our expectations.”

Read the full story about the device as covered by Northwestern News.

 

The CITRELOCK Interference Screw System will become available through Acuitive’s orthopaedic distribution partner in early 2021.  Read more about Acuitive's FDA Clearance in this release by Financial Times.