FDA Clears SAIL Fusion’s BowTie Sacroiliac Fusion System

SAIL Fusion has received U.S. Food and Drug Administration (FDA) clearance for its BowTie Sacroiliac Fusion System. Touted as the first SI fusion technology based on long-standing, validated joint fusion principles established by the AO foundation, BowTie is reportedly the sole commercially available device that incorporates both intra‑articular and transfixing components.
 
The MIS BowTie technology and its posterior-inferior surgical technique minimize tissue disruption, thoroughly prepare the joint, and provide rigid fixation to enable arthrodesis. The device features a bowtie shape as well as integrated transfixation and iliac screws to maximize rigidity. It also utilizes a proprietary porous structure and roughened surface technology to facilitate osteointegration.
  
“There hasn’t been meaningful differentiation in the SI fusion market for many years,” SAIL Fusion President/CEO David Jansen said. “By interviewing hundreds of surgeons, we were able to identify an unmet need for robust fixation built on proven AO 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.”

The system will be launched to a select group of initial surgeons in preparation for a greater expansion in the coming months.
 
“I had the pleasure of assisting with the first implantations of the BowTie device as part of an international pilot study last October. It became abundantly clear that the only way to simultaneously accomplish two of the AO’s main joint fusion principles—minimal tissue disruption and thorough joint preparation with grafting—is through a posterior-inferior approach that gives full longitudinal access to the joint,” said Dr. Peter Whang, professor of Orthopaedics and Rehabilitation at the Yale University School of Medicine. “We were able to thoroughly decorticate the joint through a small shallow incision that completely avoided all major neurovascular structures. It’s not surprising to me that the early clinical results have been very encouraging.”
 
“The BowTie device, with its trademark bowtie shape, was designed to help achieve the AO’s other significant joint fusion principle of rigidly fixating the joint to provide a biologic environment favorable for bone growth,” Jansen added. “We reinforced its rigidity by adding both integrated iliac and transfixation screws to address the complex biomechanics of the pelvis. We are pleased that BowTie’s multiplanar approach to fixating the joint also closely aligns with both the Transfixation and the recently established Intra-Articular CPT codes. This is an exciting time for surgeons, and especially for patients struggling with chronic SI joint pain.”
 
SAIL Fusion is a medical device company advancing sacroiliac joint dysfunction treatment. Co-founded with orthopedic surgeons Dr. Hyun Bae, Dr. Vikas Patel, and Whang, SAIL Fusion is a Cor Medical Ventures portfolio company.