Captiva Spine has received 510(K) clearance from the US Food and Drug Administration (FDA) to market its enhanced TowerLOX minimally invasive pedicle screw system.
A Captiva Spine press release lists the enhancements to the TowerLOX pedicle screw system’s tower system for minimally invasive spine surgery, which include:
- PivoQuik rod inserter (patent pending) and Tower Guide—offer “simple and quick” rod alignment and placement.
- Modular Open Tower—proprietary locking mechanisms (patent pending) designed to prevent inadvertent tower detachment and allow for rod insertion and visualisation through the central shaft of the tower.
- Reduction set screw driver—allows for rod reduction through the tower without wound expansion while simultaneously driving the set screw.
- PivoRod LP (low profile)—provides efficient rod angle adjustment and detachment for the inserter.
Dale Mitchell, president and founder of Captiva Spine said, “We have obsessively invested time collaborating with leading minimally invasive spine surgeons, discovered new resources through our vendor partners, and delivered coordinated enthusiasm through all aspects of this project.”
Mitchell also stated that, “During our collaborations with numerous spine surgeons it became very clear that aside from creating a thoughtful and elegant minimally invasive pedicle screw system, it was very important that these enhancements allowed the surgeon to approach challenging surgical situations with confidence.”