Spinal Elements received FDA clearance to market the Lotus Posterior Cerivcal/Thoracic Spinal System with expanded indications for posterior cervical screw placement.
Here are five key notes:
1. The previous clearances allowed only thoracic (T1-T3) spine placement. Surgeons can now place screws in the cervical (C1-C7) spine.
2. The new indication makes Spinal Elements one of three companies in the posterior cervical-thoracic space to achieve expanded indication clearance.
3. The Lotus system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It can be used in instability, deformity, failed fusion, tumors and degenerative cases.
4. The system was also designed to restore the spinal column's integrity even without fusion for a limited time period in patients with advanced stage tumors involving the cervical spine if life expectancy is an insufficient duration to permit fusion.
5. Lotus can connect to the Mercury Spinal System for different diameter transition rods.