The FDA cleared Charlotte, N.C.-based Intelligent Implant Systems' Revolution Spinal System's two-level components.
Here are five points:
1. Surgeons can now use the Revolution Spinal System for two-level posterior thoraco-lumbar fusions.
2. Implanted with a single tray of all-sterile instruments, the system requires no contoured rods or screw placements. It offers controllable compression and distraction.
3. The system is intended to accelerate OR turn time as it simplifies procedures.
4. The two-level system uses the existing Revolution Connectors and a few additional components.
5. One-level sales began in October 2015, and many hospitals and ambulatory surgery center surgeons have used the system.
"With the addition of the two-level components the potential usage of the implant system now applies to the majority of patients, as most fusion are one and two-level," said Marc Richelsoph, CEO, Intelligent Implant Systems.