SAIL Releases BowTie Sacroiliac Fusion System in U.S.

SAIL Fusion has launched its BowTie sacroiliac (SI) fusion system in the U.S.
 
The recently U.S. Food and Drug Administration (FDA)-cleared BowTie is the first SI fusion technology based on longstanding, validated joint fusion principles established by the AO foundation. It’s now the only commercial device with both intra-articular and transfixing components.
 
The MIS (minimally invasive surgical) BowTie and its posterior-inferior surgical technique accomplish the AO-based principles of minimal tissue disruption, thorough joint preparation, and rigid fixation. This achieves true and robust arthrodesis, according to SAIL.
 
A novel bowtie shape and integrated transfixation and iliac screws help maximize rigidity. A proprietary porous structure and roughened surface technology also facilitate osteointegration.
 
The first U.S. surgery using BowTie was performed on June 11, by Pierce Nunley, MD, Director of the Spine Institute of Louisiana, at Shreveport’s Spine Center of Excellence. He said BowTie directly addresses the sacrum and ilium’s joint decortication with good bleeding bone for early osseointegration.
 
“Then placing a device that really has three biomechanical fixations: one is the BowTie that creates an interlocking fixation, two is the iliac screw, and three is the transfixation screw that crosses the ilium and into the sacrum,” Dr. Nunley told the press. “This is the best combination to ensure an extremely high fusion rate. There’s nothing else like it.”

This first domestic surgery marks a limited commercial release in the U.S. The company plans to expand BowTie’s release in the coming months.
 
“We are extremely excited to begin our limited commercial release of BowTie here in the United States,” added David Jansen, president and CEO of SAIL. “This is an important milestone in recognizing surgeons’ desire to bring AO principles to SI fusion procedures. Dr. Nunley’s procedure today is the first major step in disrupting an SI fusion industry that has been far too reliant on lateral devices that are more appropriate for stabilization than true joint fusion.”