Sam Brusco, Associate Editor04.02.24
Kelyniam Global and Fin-ceramica, Faenza S.p.a., makers of custom cranial implants, have earned U.S. Food and Drug Administration (FDA) 510(k) clearance for the NEOS Surgery Cranial LOOP fixation system for use with Finceramica’s CustomizedBone hydroxyapatite (HA) cranial implant.
The Cranial LOOP devices are a smart system made of biocompatible polymer PEEK-OPTIMA to securely fix bone flaps after craniotomies. Initially cleared by the FDA in 2010, Cranial LOOP is used in public and private hospitals in 25 countries worldwide.
The system provides implant fixation in under two minutes using three devices. Because it’s made from PEEK, it has radiolucency for artifact-free CT and MRI during post-op monitoring.
Ross Bjella, Kelyniam's CEO, said, "This approval will further boost Kelyniam's sales momentum which started in Q4 last year. Alongside the low infection rate and pediatric indication, the rapid fixation provided by the Cranial LOOP system is now an added benefit for neurosurgeons choosing CustomizedBone for their patients."
Cost-wise, Cranial LOOP compares to traditional plate and screw systems, the company said. Kelyniam exclusively distributes CustomizedBone implants with the NEOS Cranial LOOP in the U.S.
Since 2004, over 9000 CustomizedBone HA implants have been sutured in place. HA is similar to human bone and facilitates seamless osteo-integration into patients' skulls. CustomizedBone is recognized for reduced infection risk and is indicated for children as young as seven.
The Cranial LOOP devices are a smart system made of biocompatible polymer PEEK-OPTIMA to securely fix bone flaps after craniotomies. Initially cleared by the FDA in 2010, Cranial LOOP is used in public and private hospitals in 25 countries worldwide.
The system provides implant fixation in under two minutes using three devices. Because it’s made from PEEK, it has radiolucency for artifact-free CT and MRI during post-op monitoring.
Ross Bjella, Kelyniam's CEO, said, "This approval will further boost Kelyniam's sales momentum which started in Q4 last year. Alongside the low infection rate and pediatric indication, the rapid fixation provided by the Cranial LOOP system is now an added benefit for neurosurgeons choosing CustomizedBone for their patients."
Cost-wise, Cranial LOOP compares to traditional plate and screw systems, the company said. Kelyniam exclusively distributes CustomizedBone implants with the NEOS Cranial LOOP in the U.S.
Since 2004, over 9000 CustomizedBone HA implants have been sutured in place. HA is similar to human bone and facilitates seamless osteo-integration into patients' skulls. CustomizedBone is recognized for reduced infection risk and is indicated for children as young as seven.