Tenon Medical shared preliminary data for its Catamaran sacroiliac joint fusion system.
The Catamaran Mainsail study is ongoing across six clinical sites in the U.S. The implant is designed to transfix the SI joint along its longitudinal axis and provides immediate fixation and stabilization.
Seven things to know:
1. Preliminary data focused on 33 patients treated with the device and follow-up after six months, according to a Sept. 16 news release.
2. The data shows significant dips in the mean visual analogue scale pain intensity scores from pre-operative levels of 80.9mm to 31.1mm after having surgery with Catamaran.
3. Oswestry Disability Index scores also saw improvement from pre-operative values of 51.9% to 29.6%. Two-thirds of the patients had an improvement of more than 15%.
4. None of the patients had serious adverse events or reoperations, and there were not any vascular or nerve injuries associated with the inferior-posterior surgical approach for the Catamaran implant.
5. Nearly all patients (99.3%) reported high satisfaction with their treatment after six months.
6. More than half of the cases were completed in less than 45 minutes, and the shortest procedure was 24 minutes long. All of the patients had the procedure done in the outpatient setting.
7. "This clinical data continues to validate our ongoing conviction that the Catamaran's novel transfixing design, less invasive inferior-posterior approach and utilization of AO principles to promote true fusion position it as one of the most innovative implants available to safely and effectively reduce pain and disability in patients suffering with SI joint disease," Tenon Medical CEO Steven Foster said in the release.