Demonstrates Rapid Growth of Family of Devices Designed to Participate in Fusion Without Compromising Mechanical Integrity or Radiographic Visibility
DEERFIELD, Ill., June 06, 2019 (GLOBE NEWSWIRE) — RTI Surgical Holdings, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced a milestone of 5,000 implants of Fortilink®-C, -TS and -L Interbody Fusion (IBF) Systems with TETRAfuse® 3D Technology in the United States.
“In my over 500 implantations, I have been extremely satisfied with the Fortilink-TS and -C IBF devices”, said Dr. Mario Brkaric, co-founder of the Indiana Spine Center. “I have had no intra-operative or post-operative issues and have seen no issues with cage migration. Visualization in the office on postoperative X-rays has also been great.”
RTI Surgical commercially launched the Fortilink-C IBF System for use in anterior cervical discectomy and fusion (ACDF) surgeries in October 2017. It was the first in a family of devices to incorporate RTI Surgical’s TETRAfuse 3D Technology intended for use in patients with degenerative disc disease. Following the successful launch of the Fortilink-C IBF System, the company commercially launched both the Fortilink-TS and -L IBF Systems with TETRAfuse 3D Technology to be used in lateral lumbar interbody fusion (LLIF) and transforaminal lumbar interbody fusion (TLIF) or bilateral posterior lumbar interbody fusion (PLIF) surgeries, respectively. Since launch, the Fortilink family of devices has experienced significant growth in the total number of implants from Q1 2018 to Q1 2019.
“This milestone of 5,000 implants for the Fortilink family of devices with TETRAfuse 3D Technology reinforces surgeon confidence in this award-winning technology,” said Camille Farhat, President and CEO, RTI Surgical. “Adding to this confidence, we are investing in our commitment to clinical data through our FORTE study to show definitive outcomes for patients for pain reduction and procedural and long-term performance. Our Fortilink series remains a key platform within our increasingly differentiated spine portfolio poised to drive growth in Spine for RTI in 2019 and beyond. We are looking forward to the next milestone as we continue to treat more patients.”
TETRAfuse 3D Technology is featured in the growing family of Fortilink IBF devices to help drive optimal outcomes for patients undergoing spinal fusion procedures. It features a nano-roughi surface with antibacterial characteristics†iii designed to participate in fusionii without compromising mechanical integrityi or radiographic visibilityi. TETRAfuse 3D Technology recently won a 2019 MedTech Breakthrough Award for “Best New Technology Solution – Orthopedics” and a 2018 Spine Technology Award from Orthopedics This Week. For more information, please visit www.tetrafuse3D.com.
About RTI Surgical Holdings, Inc.
RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in spine, sports medicine, general surgery, orthopedic and trauma procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, visit www.rtix.com. Connect with us on LinkedIn and Twitter.
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i Data on file at RTI Surgical, Inc.
ii Data on file at RTI Surgical, Inc. Performance data from animal studies may not be representative of performance in humans.
iii Wang M, Bhardwaj B, Webster T; Antibacterial properties of PEKK for orthopedic applications. Int’l Journal of Nanomedicine. 2017: 12 6471-6476.
† Lab data may not be representative of the effects with all bacteria or performance when implanted in humans. Staphyloccocus epidermidis and Pseudomonas aeruginosa were subject bacterial strains in this study.
Please refer to the labeling for clinical applications, warnings, precautions and other instructions for use.
SOURCE: Globe Newswire, 6th June 2019