RTI SurgicalĀ enrolled the first patient in a clinical evaluation of the FortilinkĀ® 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 TETRAfuseĀ® 3D printed polymer material. Its primary objectiveĀ is to assess radiographic evidence ofĀ fusionĀ at three monthsĀ (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, exploringĀ 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 forĀ study data collection. All subjects are expected to be enrolled in 1Q20.
RTI launched the cervical device in 2017; lumbar versions were released in 2018.
Sources: RTI Surgical, Inc.; ORTHOWORLD Inc.
RTI SurgicalĀ enrolled the first patient in a clinical evaluation of the FortilinkĀ® 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 TETRAfuseĀ® 3D printed polymer...
RTI SurgicalĀ enrolled the first patient in a clinical evaluation of the FortilinkĀ® 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 TETRAfuseĀ® 3D printed polymer material. Its primary objectiveĀ is to assess radiographic evidence ofĀ fusionĀ at three monthsĀ (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, exploringĀ 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 forĀ study data collection. All subjects are expected to be enrolled in 1Q20.
RTI launched the cervical device in 2017; lumbar versions were released in 2018.
Sources: RTI Surgical, Inc.; ORTHOWORLD Inc.
You are out of free articles for this month
Subscribe as a Guest for $0 and unlock a total of 5 articles per month.
You are out of five articles for this month
Subscribe as an Executive Member for access to unlimited articles, THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT and more.
JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.