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RTI Surgical Enrolls 1st Patient in FORTE Clinical Study of Fortilink Interbody -

RTI Surgical enrolled the first patient in a clinical evaluation of the Fortilink® interbody fusion device in the treatment of degenerative disc disease. The study, named FORTE, is a prospective, postmarket evaluation of the safety and performance of the Fortilink-C, -TS, and -L Interbody Fusion systems made with TETRAfuse® 3D printed polymer material. Its primary objective is to assess radiographic evidence of fusion at three months (Fortilink-C IBF) or six months post-op (Fortilink-TS and Fortilink-L IBF). The FORTE study will collect and evaluate real world data on adult subjects, exploring pain reduction and procedural and long-term performance. The multicenter study will include 150 patients at up to 20 sites in the U.S. over the next 3.5 years, with post-procedure evaluations post-procedurally at intervals throughout 24 months for study data collection. All subjects are expected to be enrolled in 1Q20. (RTI Surgical, 3/20/19)