Medical device company LDR has received approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C), for two-level indications in the US.
The Mobi-C is designed for cervical disc replacement to restore segmental motion and disc height.
It is claimed to be the first mobile-bearing, bone-sparing cervical disc replacement approved in the US market to treat more than one level of the cervical spine.
Earlier this month, LDR received a letter of approval from the FDA allowing the commercial sale and distribution of the Mobi-C for one-level use.
Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis developed as an on-label, arthroplasty solution for the significant number of patients suffering from two-level cervical disc disease.
Compared to other commercially available devices, Mobi-C offers a simplified surgical technique.
In multi-center clinical trials, Mobi-C demonstrated statistical superiority for two-level use as compared to fusion control treatment based on the primary endpoint analysis.
LDR president and CEO Christophe Lavigne noted the company is pleased that the FDA, after an intensive review of its Pre-Market Application (PMA), has determined that Mobi-C is safe and effective for both one and two-level indications in the US.
"It is very gratifying to know that spine surgeons can now offer this new, evidence-based treatment option to their two-level surgical candidates," Lavigne added.
