Study
The Catamaran® SI Joint Fusion System offers a novel, less invasive Inferior-Posterior approach to the SI joint using a single, robust titanium implant.
The System features the Catamaran® Fixation Device, which passes through both the axial and sagittal planes of the ilium and sacrum, transfixing the SI joint along its longitudinal axis.
Catamaran SI Joint Fusion System MAINSAIL™ Study:
The MAINSAIL Study is a prospective, single-arm, multi-center, post-market study that assesses the safety and efficacy of the inferior-posterior approach using the Catamaran SI Joint Fusion system for up to 24 months. This interim analysis presents clinical outcomes of the first 33 consecutive patients at the primary endpoint of 6 months, with initial radiographic CT fusion assessment, at 12 months, performed by an independent radiologist.
RATE
REDUCTION (VAS) (p<0.001)
IMPROVEMENT (ODI) (p<0.01)
SATISFACTION
- No Serious Device Related Adverse Events
- No Reoperation
- No Reintervention
Davies M, Dreischarf M, Yusufbekov R. Catamaran SI Joint Fusion System(R) MAINSAILTM Study: a prospective, single-arm, multi-center, post-market study of six-month clinical outcomes and twelve-month radiographic findings. Expert Rev Med Devices. 2024 Sep;21(9):851-858. doi: 10.1080/17434440.2024.2394168. Epub 2024 Aug 29. PMID: 39161110.
Primary Composite Endpoint/Success Rate:
At 6 months, 80% of patients met the criteria for success, defined as a ≥ 20mm reduction in SIJ pain, no serious device-related adverse events, no neurological worsening, and no surgical re-intervention.
Pain Reduction (VAS):
Visual Analog Scores (VAS) SIJ pain intensity scores (0-100) significantly decreased from baseline to 6 months, 80.9mm to 31.1mm resulting in a relative improvement of 61.6% (p<0.001).
Functional Improvement (ODI):
Oswestry Disability Index (ODI) scores signicantly improved from baseline to 6 months, 51.9% to 29.6% resulting in a relative improvement of 43% (p<0.01).
Safety:
No serious adverse events, no reoperations, and no reinterventions reported. No vascular or nerve injuries associated with the use of the inferior-posterior surgical approach used to deliver the Catamaran implant.
Patient Satisfaction:
93.3% of patients reported high satisfaction with their treatment at 6 months.
Fusion Radiographic Outcomes:
12-month follow-up with CT radiographic imaging, 4 of the 6 patients demonstrated fusion with bridging bone as performed by an independent radiologist.
read the full articleA Better Option for SI Joint Fusion
Favorable Entry
Direct access to the SI joint provides optimal entry point to facilitate arthrodesis
Inferior-Posterior Approach
Trajectory is angled away from critical neural and vascular structures
Optimized Placement
Designed for maximum fixation in the dense cortical bone of the SI joint, inferior to the dorsal recess
Single, Robust
Titanium Implant
A single implant that transfixes the SI joint
The Catamaran SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis
Utilizing a 2D fluoroimaging sequence, the Catamaran Fixation Device is implanted with one pontoon fixated into the ilium and the other into the sacrum, transfixing the SI joint along its longitudinal axis.
MODIFIED OUTLET VIEW
Implant Trajectory
MODIFIED INLET VIEW
Implant Entry
LATERAL
VIEW
Implant Depth
Catamaran SI Joint Fixation
Device:
Design & Specifications
Joined by a patented transfixing osteotome bridge, the implant consists of two hollow fenestrated pontoons with an open framework designed for packing with autologous bone to facilitate bony in-growth through the SI joint.
The transfixing osteotome is designed to disrupt the articular portion of the joint to help facilitate a fusion response.
Catamaran Biomechanical Characterization and Testing
In mechanical testing, the Catamaran Fixation Device performed favorably as a reliable sacroiliac joint fixation/stabilization system that greatly exceeded the biomechanical thresholds of the sacroiliac joint.
Ferrara, Lisa A. Performance Integrity of the Catamaran® SI Joint Fixation Device in a Novel, Inferior-Posterior Approach for Sacroiliac Joint Fusion. Rev. 1, Tenon Medical, Inc., 2022.
If you would prefer a printed copy of any of these documents sent to you, please contact Tenon Customer Service at 1-844-211-2540.
A Single Center Experience with the
Catamaran SI Joint Fusion System
Early clinical experience has shown that the Catamaran® SI Joint Fixation Device via an inferior-posterior approach has the potential to deliver significant & sustained reduction in SI joint pain, as well as:
Chaparro, Michael J. Sacroiliac Joint Fusion: Improving Surgical Outcomes Through an Inferior-Posterior Approach with the Tenon Medical Catamaran® SI Joint Fusion System. Rev. 1, Tenon Medical, Inc., 2022
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