Sail Fusion receives FDA clearance of sacroiliac fusion system
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Key takeaways:
- Sail Fusion announced FDA clearance of its BowTie sacroiliac fusion system.
- The BowTie system utilizes a posterior-inferior surgical technique and includes intraarticular and transfixing components.
Sail Fusion announced FDA clearance of its BowTie sacroiliac fusion system with intraarticular and transfixing components, according to a press release.
The BowTie system is designed for minimally invasive fixation utilizing a posterior-inferior surgical technique. The system also features integrated transfixation and iliac screws, according to the release.
“There hasn’t been meaningful differentiation in the [sacroiliac] SI fusion market for many years,” David Jansen, president and CEO of Sail Fusion, said in the release. “By interviewing hundreds of surgeons, we were able to identify an unmet need for robust fixation built on proven AO [foundation] principles. Our approach challenges the prevailing trend of lateral fixation that is more appropriate for stabilization rather than true joint fusion. To achieve this, BowTie leverages decades of clinically validated arthrodesis methods that have been applied to nearly every other joint.”
According to the release, the system will be launched to a select group of surgeons with expansion planned for the coming months.
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