NEOS Cranial LOOP™ Receives FDA Clearance for CustomizedBone™ Use
The Cranial LOOP™ family of cranial fixation devices is a smart system made of PEEK-OPTIMA™, a biocompatible polymer, for securely fixing bone flaps after craniotomies. With more than 10 years of market experience, Cranial LOOP™ is being used in public and private hospitals in 25 countries worldwide. Cranial LOOP™ was first cleared by the FDA in 2010. The most recent 510k clearance is for use specifically with Finceramica's CustomizedBone™ hydroxyapatite cranial implant.
Since 2004 over 9000 CustomizedBone™ hydroxyapatite implants have been sutured in place. Hydroxyapatite, similar to human bone, facilitates seamless osteo-integration into patients' skulls. CustomizedBone™ is internationally recognized for its reduced infection risk and is indicated for use in children as young as 7 years old.
The NEOS Surgery Cranial LOOP™ system offers rapid implant fixation in under two minutes using just three devices. Crafted from PEEK (poly ether ether ketone), it ensures radiolucency for artifact-free imaging (CT and MRI) during post-operative monitoring. Cost-wise, Cranial LOOP™ is comparable to traditional plate and screw systems. Kelyniam exclusively distributes CustomizedBone™ implants with the NEOS Cranial LOOP™ in the
About Finceramica
Fin-Ceramica Faenza S.p.A. founded in as a spin-off from the
About Kelyniam
As a cautionary note to investors, certain matters discussed in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such matters involve risks and uncertainties that may cause actual results to differ materially, including the following: changes in economic conditions; general competitive factors; the Company's ability to execute its service and product sales plans; changes in the status of ability to market products; and the risks described from time to time in the Company's
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