First Patient Enrolled in RTI Surgical’s FORTE Clinical Study

RTI Surgical Holdings Inc., a global surgical implant company, announced it enrolled the first patient in its Clinical Evaluation of Fortilink Interbody Fusion Device with TETRAfuse3D Technology in Subjects with Degenerative Disc Disease (FORTE) study. FORTE is a prospective, multicenter post-market evaluation of the safety and performance of the Fortilink-C, -TS, and -L Interbody Fusion (IBF) Systems with TETRAfuse 3D Technology, which recently won a 2018 Orthopedics This Week Spine Technology Award. The primary objective of the study is to assess radiographic evidence of cervical and lumbar fusion evaluated by an independent core laboratory at 3-months post-surgery (Fortilink-C IBF System) or 6-months post-surgery (Fortilink-TS and Fortilink-L IBF Systems).
 
“I’ve really been impressed with the TETRAfuse implants so far,” said Dr. K. Brandon Strenge, at The Orthopaedic Institute. “I’m excited to see the bone growth showing on the CT scans, unlike the titanium implants out there. The lateral implants have a great variety of lordotic options and sizes to accommodate any situation a surgeon may encounter.”
 
“While PEEK implants are widely used, data suggest PEEK has minimal characteristics to enhance implant osseointegration,” said Dr. Christopher Kepler, MBA, at The Rothman Orthopaedic Institute. “The porous Fortilink cages with TETRAfuse 3D Technology have the potential to create a favorable environment for bone growth and are radiolucent. I look for the ongoing FORTE study to introduce surgeons to this product and demonstrate the advantages of Fortilink cages over other cage materials.”
 
The FORTE study will collect and evaluate real world data on adult subjects with degenerative disc disease (DDD) to explore pain reduction and procedural and long-term performance. The scope of the study is to evaluate 150 patients at up to 20 sites in the U.S. over the next 3.5 years, with evaluations post-procedurally at intervals of 1,3, 6, 12 and 24 months for the purposes of study data collection. All subjects are anticipated to be enrolled in Q1 2020.
 
“RTI is committed to providing innovative, safe and effective spine solutions that are supported by clinical research,” said Camille Farhat, President and CEO, RTI Surgical. “The FORTE study aims to reinforce physician confidence and expand access for patients by showing improved outcomes for appropriate DDD patients based on the unique properties of TETRAfuse 3D Technology. We believe TETRAfuse represents a new frontier in spine surgery with its design to participate in fusion, and its bone-like mechanical properties, radiolucency and antibacterial characteristics. Our Fortilink series remains a key platform within our increasingly differentiated spine portfolio, poised to drive growth for RTI in 2019 and beyond.”
 
TETRAfuse 3D Technology is an IBF device material that is manufactured under an exclusive license agreement with Oxford Performance Materials Inc. (OPM), which grants RTI Surgical an exclusive license to OPM’s technology for spinal applications in the U.S. TETRAfuse 3D Technology is designed to help drive optimal outcomes for patients undergoing spinal fusion procedures.