CTL MEDICAL SECURES FDA CLEARANCE FOR TITANIUM-PEEK HYBRID ACIF CAGE
By ctlmed | Posted April 5, 2018 | In News
CTL Medical, a Dallas-based medical device manufacturing and service company, has secured US Food and Drug Administration (FDA) clearance and approval to market its new MATISSE Titanium-PEEK ACIF cage system with the company’s proprietary TiCro surface technology in the practice of spinal fusion surgery.
The company claim that the MATISSE cage offers the increased bone ingrowth of Titanium, and the post-operative fusion visibility of PEEK. CTL Medical further announce that the Titanium-PEEK interbody device offers surgeons a 200% greater endplate contact surface area, as well as geometric surface morphology for increased mechanical locking at the cage and bone interface.
The press release states that the implant includes a tapered leading edge for easy insertion and a large graft area to further promote bony fusion. The device is available in a variety of sizes and configurations to accommodate variations in vertebral levels and patient anatomy.
“The MATISSE Titanium-PEEK cage with TiCro represents several improvements over earlier models,” states Rose Moore, vice-president of marketing for CTL Medical. “The MATISSE device line now offers three material options to satisfy surgeons and their patients ever changing needs. As with previous models, the Matisse Titanium-PEEK system offers streamlined instrumentation and a variety of footprints, heights, and lordotic profiles to accommodate variations in patient anatomy.”
MATISSE Titanium-PEEK Cage with TiCro is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one-disc level. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. MATISSE Titanium-PEEK Cage with TiCro is to be used with supplemental fixation.
The use of cage devices in spinal surgery began with clinical trials in 1989, and since then, multiple implant improvements have debuted – leading to easier procedures, benefitting both spine surgeons and overall patient success and recovery times.
See original story here: https://spinalnewsinternational.com/ctl-medical-matisse-acif-cage/