SpineFrontier® Receives FDA Clearance to Manufacture LES Interbody Fusion Devices Using Invibio’s PEEK-OPTIMA®HA Enhanced Biomaterial on October 20th, 2014
Beverly, MA (PRWEB) November 07, 2014 -- SpineFrontier, a Less Exposure Surgery (LES) technology company has received clearance from the FDA to develop and produce a new cervical spine implant, the Arena-C® HA. SpineFrontier’s current offering, the Arena-C, is an anterior interbody that aids in stabilizing the cervical spine. It is currently manufactured from PEEK-OPTIMA® Natural. The new Arena-C® HA implant will be manufactured with PEEK-OPTIMA®HA Enhanced.
“As SpineFrontier continues to develop Less Exposure Surgery (LES) spine implants and technologies, we plan to utilize Invibio’s PEEK-OPTIMA® HA Enhanced in the production of our future implants. SpineFrontier will diligently develop revolutionary products that promote safe, efficient surgery procedures, positive patient results and fast recovery times.” –Dr. Kingsley R. Chin
“Our Arena-C® Cervical Interbody was the perfect candidate to bring this new material to market. With the clinical guidance of our CEO, Dr. Kingsley Chin, and seamless collaboration between Invibio and SpineFrontier, we’re very excited to release our new Arena-C® HA Implant.” –Kyle Elsabee, Associate Product Manager.
PEEK-OPTIMA® Natural has been the leading biomaterial used for spinal fusion implant production for the past 10 years. PEEK-OPTIMA® HA Enhanced shares all of the properties of PEEK-OPTIMA® Natural including modulus similar to bone, radiolucency, biocompatibility and long term stability, but it has been compounded with Hydroxyapatite (HA).
The Arena-C HA will be available for purchase early 2015.
PEEK-OPTIMA® HA Enhanced image(s) provided courtesy of Invibio Biomaterial Solutions, all rights reserved.
*Pre-clinical study images depict an ovine model. Data on file at Invibio. This has not been correlated with a human clinical experience.
About SpineFrontier® Arena-C® HA Cervical Intervertebral Body Fusion Device:
The SpineFrontier Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The SpineFrontier® Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).
Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Anders Johnson, SpineFrontier, Inc., http://www.spinefrontier.com, +1 9782323990, [email protected]
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