Tenon Medical has announced the initial publication of the MAINSAIL study on the Catamaran SI Joint Fusion System. This ongoing prospective, single-arm, multi-center, post-market investigation is assessing the clinical and radiographic outcomes in adult patients experiencing sacroiliac joint disruptions or degenerative sacroiliitis who are treated with the Catamaran SI Joint Fusion System. The study aims to enroll up to 50 patients, with a follow-up period extending to 24 months. This interim analysis details early findings from the first 33 consecutive patients treated using the Catamaran SI Joint Fusion System at six clinical sites across the US, focusing on primary and secondary clinical endpoints at the 6-month marker, along with radiographic CT fusion assessments conducted by an independent radiologist. Significant findings from this interim analysis include: Statistically Significant Decrease in SI Joint Pain and Disability Scores at 6 months: Mean VAS SIJ pain intensity scores fell markedly from pre-operative levels of 80.9mm to 31.1mm; ODI scores, which assess perceived disability, improved significantly from pre-operative rates of 51.9% to 29.6%; 66.6% of participants experienced an ODI improvement exceeding 15%. Strong Safety Profile: There were no serious adverse events, no reoperations, and no reinterventions reported. No vascular or nerve injuries were linked to the inferior-posterior surgical approach utilized for the Catamaran implant. High Levels of Patient Satisfaction Across Follow-Up Points: 93.3% of patients reported high satisfaction with their treatment by the 6-month mark. Conclusive Evidence of Fusion Response at 12 months: Six patients reached the 12-month follow-up with CT imaging, where four of them exhibited clear evidence of fusion with bridging bone, as confirmed by an independent radiology reviewer. Efficient Surgical Technique and Procedure Workflow: 55% of procedures were completed in under 45 minutes, with the fastest recorded at just 24 minutes. Furthermore, 50% of procedures used less than 1 minute of fluoroscopy time. All procedures were conducted in an outpatient setting. The Catamaran SI Joint Fixation device features a single, robust titanium implant composed of two pontoons linked by an osteotome bridge, designed to transfix the SI joint along its longitudinal axis, providing immediate fixation and stabilization to achieve long-term fusion. The Catamaran implant was developed following AO arthrodesis principles including adequate joint preparation, rigid fixation and stabilization, and sufficient bone graft augmentation. Using a minimally invasive inferior-posterior approach, the Catamaran implant is introduced into the dense cortical bone of the sacrum and ilium to stabilize the SI joint, addressing SIJ dysfunction. To date, 700 Catamaran fixation devices have been implanted to address primary SI joint dysfunction and sacroiliitis, as well as to revise previously treated SI joints with failed alternative implants. These interim results from the MAINSAIL study provide early evidence of the clinical safety and efficacy of the Catamaran SI Joint Fusion System, showcasing it as a promising minimally invasive treatment option for those with painful SI joint dysfunction. The Catamaran MAINSAIL study is still active, with further analyses planned upon completion of the 24-month follow-up.
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