Meditech Spine announced they received FDA 510(k) clearance to market the CURE™ Opel-L (S) system, a new lumbar plate option that expands upon the previously cleared CURE™ LP Plate System and compliments its Talos®-A (HA) Interbody system.
With this approval, Meditech will now offer an Interbody/Plate assembly for the anterior lumbar spine. By adding the Opel™-L (S) plating option to the CURE™ LP product line and pairing it with the Talos® A (HA) interbody system, surgeons now have a nearly limitless opportunity to ideally accommodate individual patient anatomy. The new system has an increased screw angulation and repeatable, more precise A/P alignment with an optional All-in-One drill guide during the placement of the device. By combining the Opel™-L (S) and the Talos®-A (HA) Interbody, surgeons have a lower profile system and streamlined technique improving surgical efficiency while maintaining a robust anterior stabilization.
In addition, Meditech is adding and launching hyper-lordotic sizes to its existing Talos®-A (HA) line of osteoconductive PEEK-OPTIMA® HA Enhanced ALIF implants. With the current CURE™ LP system and the FDA clearance of Opel™-L (S), Meditech offers a comprehensive anterior lumbar system that gives surgeons multiple options when treating complex anterior lumbar spinal procedures. Meditech has targeted the initial launch for this integrated system to take place in the 3rd quarter of 2020. This is the first of three anticipated clearances this year for Meditech Spine.
Meditech continues its relationship with CURE International, the namesake of the CURE ACP, an organization that serves children with physical disabilities in underserved areas of the world. A portion of proceeds from the sale of every plate will help CURE International treat patients in underserved areas who are in need of surgical care.