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Custom Spine announced today that it has received FDA clearance to market the PATHWAY Transforaminal Lumbar Interbody Fusion (TLIF) spacer for degenerative, damaged, unstable or collapsed discs. PATHWAY TLIF was introduced during the Congress of Neurological Surgeons annual meeting being held in Orlando, FL.
The PATHWAY TLIF is manufactured from PEEK-OPTIMA® which is the registered trademark of INVIBIO®. PEEK (Poly-Ether-Ether-Ketone) is an implantable grade polymer, which is a synthetic, semi-crystalline organic thermoplastic that is radiolucent and biocompatible. The design of the implant allows for a generous amount of bone graft to be inserted into the dual reservoirs, promoting in-growth between bone graft and adjacent tissue.
Additionally, the customized implant inserter has a non-threaded design providing a secure attachment between implant and inserter. This unique feature prevents cross threading and minimizes implant breakage. “We are excited to continue expanding our product portfolio in the spine market with innovative solutions that provide benefits to the surgeon as well as the patient”, stated Mahmoud Abdelgany, President and CEO.
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