AUSTIN, Texas, Oct. 20, 2015 (GLOBE NEWSWIRE) — LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, today announced that the U.S. Food and Drug Administration (FDA) has cleared the ROI-C® Cervical Cage for use with allograft. Previously the device was cleared only for use with autogenous bone graft.
The Indications for Use of the LDR ROI-C Cervical Cage have been expanded to permit use with allograft. LDR presented comprehensive, clinical literature review data to the FDA to investigate the risks and benefits associated with using allogenic bone graft with ROI-C. The published clinical outcomes demonstrated that the use of allograft (i.e., cancellous and/or corticocancellous bone graft) in cervical interbody fusion devices to treat patients diagnosed with cervical degenerative disc disease poses no new risks to patients.
Dr. Darrell C. Brett, a neurosurgeon at Northwest Spine and Laser Surgery in Portland, Oregon shared, “The addition of on-label clearance for the use of allogenic bone graft in the ROI-C is a positive step in the FDA acknowledging how the cage can best be used to treat well-indicated patients. I am pleased that use of allograft is now a cleared application.”
The ROI-C Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. The cage is to be used with autogenous or allogenic bone graft. Supplemental internal fixation is required to properly utilize this system. As specifically stated in the device description in the cleared 510(k) Summary, VerteBRIDGE® Plating can be inserted to “obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct.”
“It is a positive step forward that this expanded indication for the stand-alone ROI-C Cervical Cage reflects the common surgical practice of using allograft bone in cervical cages to promote fusion,” said LDR President and CEO Christophe Lavigne. “For patients who may not be good candidates for disc replacement with the Mobi-C® Cervical Disc and therefore may turn to cervical fusion as an alternative, the ROI-C is designed to be inserted via a minimally invasive, direct access approach to the disc while avoiding the need for the traditional cervical plate with four screws. In keeping with our Minimal Implant Volume (MIVo™) surgery philosophy, we believe that there is inherent benefit in performing the least amount of surgery necessary and minimizing the implanted materials required to achieve the desired outcome. This is very attractive to both surgeons and patients.”
Indications for Use: ROI-C Cervical Cage System
The LDR Spine ROI-C Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine ROI-C Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.
Device Description: ROI-C VerteBRIDGE Anchoring Plate
The ROI-C VerteBRIDGE anchoring plate, made of titanium alloy (Ti6Al4V) can be inserted to obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct. The anchoring plate locks securely in place to the PEEK implant via locking tabs on either side of the anchoring plate.
About LDR Holding Corporation
LDR Holding Corporation is a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders. LDR’s primary products are based on its exclusive Mobi® non-fusion and VerteBRIDGE fusion technology platforms and are designed for applications in the cervical and lumbar spine. These technologies are designed to enable products that are less invasive, provide greater intra-operative flexibility, offer simplified surgical techniques and promote improved clinical outcomes for patients as compared to existing alternatives. In August 2013, LDR received approval from the FDA for the Mobi-C cervical disc replacement device, the first and only cervical disc replacement device to receive FDA approval to treat both one-level and two-level cervical disc disease. For more information regarding LDR Holding and the Mobi-C Cervical Disc, visit www.ldr.com or www.cervicaldisc.com.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include the intent, belief or current expectations of LDR and members of its management team with respect to LDR’s future business operations as well as the assumptions upon which such statements are based. Factors that could cause actual results to differ materially from those contemplated within this press release can also be found in LDR’s Risk Factors disclosure in its Annual Report on Form 10-K, filed on February 20, 2015, and in LDR’s other filings with the SEC. LDR disclaims any responsibility to update any forward-looking statements.
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