Tenon Medical announces publication of Catamaran SI Joint Fusion System study

Tenon Medical announced the first publication of the Catamaran SI Joint Fusion System MAINSAIL study. This study is an ongoing prospective, single-arm, multi-center, post-market study evaluating clinical and radiographic outcomes of adult patients with sacroiliac joint disruptions or degenerative sacroiliitis treated with the Catamaran SI Joint Fusion System. The target enrollment for this study is up to 50 patients with up to 24-month follow-up. This interim analysis presents early experiences of the first 33 consecutive patients treated with the Catamaran SI Joint Fusion System across six US clinical sites, with primary and secondary clinical endpoint analysis at 6 months and radiographic CT fusion assessment, performed by an independent radiologist. Notable outcomes from this interim analysis include the following: Statistically Significant Reduction in SIJ Pain and Disability Scoring at 6 months: Mean VAS SIJ pain intensity scores significantly decreased from pre-operative levels of 80.9mm to 31.1mm; ODI scores, measuring a patient’s perceived disability, showed a significant improvement from pre-operative values of 51.9% to 29.6%; 66.6% of subjects demonstrated an improvement in ODI by more than 15%. Robust Safety Profile: 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. High Patient Satisfaction Throughout All Follow-Up Timepoints: 93.3% of patients reported high satisfaction with their treatment at 6 months. Definitive Evidence of Fusion Response at 12 months: 6 patients have reached 12 months follow-up with CT radiographic imaging. 4 of the 6 patients showed unequivocal evidence of fusion with bridging bone as identified by an independent radiology reviewer. Efficient Surgical Technique and Procedural Workflow: 55% of procedures were completed in under 45 minutes, with the shortest procedural time recorded as 24 minutes. 50% of procedures utilized less than 1 minute of fluoroscopy time. All procedures were performed in an outpatient setting. The Catamaran SI Joint Fixation device is a single robust titanium implant comprised of two pontoons, connected by an osteotome bridge, which is designed to transfix the SI joint along its longitudinal axis providing immediate fixation and stabilization of the joint, with the aim of achieving a successful long-term fusion. The Catamaran implant was developed with respect to AO principles of arthrodesis including adequate joint preparation, rigid fixation and stabilization, and 3) adequate bone graft augmentation. Via a minimally invasive inferior-posterior approach the Catamaran implant is delivered within the dense cortical bone of the sacrum and ilium, to transfix and stabilize the SI joint for the treatment of SIJ dysfunction. To date, there have been 700 Catamaran fixation devices implanted to treat primary SI Joint dysfunction and sacroiliitis, as well as revise previously treated SI joints with failed alterative SI joint implants. These interim outcomes from the MAINSAIL study provide early evidence of the clinical safety and efficacy of the Catamaran SI Joint Fusion System as a promising minimally invasive treatment option for patients suffering from painful SI joint dysfunction. The Catamaran MAINSAIL study is on-going and further analysis will be performed upon study completion up to 24-month follow-up.