30 Day Trial

Study Results: Rotation Medical Bioinductive Implant in Rotator Cuff Tears

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Study results indicate that Rotation Medical's collagen-based Bioinductive Implant induced new tissue formation in all study participants with large and massive rotator cuff tears.

The study enrolled 23 patients, breaking down to 11 with large (two tendon) and 12 with massive (three tendon) rotator cuff tears, 16 of whom had undergone previous rotator cuff repair. All patients received the Rotation Medical Bioinductive Implant arthroscopically. New tissue formation was observed in all patients, with 22 successfully-healed rotator cuffs. Rotator cuff thickness ranged from 5mm to 9 mm at most recent follow-up, and all clinical scores improved significantly over time.

The Bioinductive Implant received FDA 510(k) clearance in 1Q14. Additional studies have shown the implant's ability to induce new tissue formation in partial thickness rotator cuff tears as well as its ability to promote new connective tissue with the appearance of tendon.

Earlier this year, OrthoSpace shared long-term follow-up study results indicating that a cohort of 20 patients with massive rotator cuff tears that were treated with the InSpace™ system showed improvements in function and pain at 6 weeks, with effects maintained for up to 5 years. 

Rotation Medical is exhibiting at the 2017 AAOS meeting in Booth #5916. OrthoSpace can be found in Booth #311.

Sources: Rotation Medical, Inc.; ORTHOWORLD Inc.