WAYNE, Pa., May 5, 2016 – Camber Spine Technologies announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ENZA™ Zero Profile Anterior Interbody Fusion (ALIF) system, a unique, minimally invasive interbody fusion device providing integrated fixation. This clearance marks Camber’s eighth line of spinal implant systems to be released in the US market.
The ENZA™ Zero Profile ALIF system is intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. The system is intended for use with bone graft and with supplemental fixation systems. The ENZA™ bladed stabilization system, utilizes a simple, one-step insertion and fixation method through a minimally invasive approach to achieve interbody fusion.
“We are pleased to receive 510(k) clearance for the Enza system, the latest addition to Camber’s product offerings in spine stabilization. This important milestone marks the beginning of a year in which we hope to launch several differentiated technologies and continue to expand our presence to new geographies. Camber’s mission is to deliver surgeon inspired technologies to the patient.”
The ENZA™ product was developed under a collaborative agreement with the Institute for Musculoskeletal Science & Education (IMSE), an independent, full-service product development and engineering services company enabling medical device companies to expedite the commercialization of their technologies.
CAMBER SPINE TECHNOLOGIES LAUNCHES TWO NEW PRODUCTS
2016 Commercial Product Launches
Wayne, PA, April 26, 2016– Camber Spine Technologies is proud to announce the launch of PROLIX™ and ORTHROS MIS™
The PROLIX™ SI Fusion System provides a safe, minimally invasive approach for what Camber believes is the first true fusion product designed to treat Sacro-Iliac pain. The system utilizes an safe inferior approach between the posterior superior iliac spine (PSIS) and the posterior inferior iliac spine (PIIS). A machined cortical bone spacer is implanted between the sacrum and ilium through a special cannula. The space is now treated like a discectomy to help promote fusion as opposed to only limiting motion of the joint when solely using lateral screws. PROLIX™ used in conjunction with lateral screws has the potential to decrease the opportunity for revisions by providing a true fusion technique to the spinal implant market to treat Sacro-Iliac pain. Cases are currently being performed so contact Camber Spine to see how you can use PROLIX™ in your hospital or practice.
The ORTHROS MIS™ Posterior Stabilization System is the latest addition to Camber’s high performing ORTHROS™ brand pedicle screws. The MIS version of the system includes breakaway screw head extensions which facilitate the MIS technique. The pedicle screws are designed to provide rod reduction within the screw head. An effective instrument combination for compression and distraction enables the surgeon to adjust the spinal segments instead of toggling polyaxial screw heads. The Rod Inserters are some of the most rigid and small stature Inserters on the market which further facilitate an MIS technique. The system provides a flexibility unlike any other to promote the different techniques used for MIS surgery. There are (4) different Dilation options which can reduce the number of steps used to implant each pedicle screw. Neuro-monitoring is easily performed through the PEEK Dilators and Tap Sleeve.
