AUSTIN, Texas, June 02, 2016 (GLOBE NEWSWIRE) — LDR Holding Corporation (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 the initial implantations of the ROI-C® Titanium-Coated Cervical Cage. The first surgeries were performed by Dr. Mark Giovanini, a board-certified neurosurgeon specializing in minimally invasive spine surgery in Pensacola, Florida, and Dr. Neil Romero, a board-certified orthopedic surgeon specializing in minimally invasive spine surgery and arthroplasty in Lafayette, Louisiana.
Dr. Giovanini shared, “The addition of ROI-C Titanium-Coated implants is a big step forward. ROI-C’s VerteBRIDGE®plating system makes for procedural simplicity, and I could feel the additional friction provided by the titanium coating.” Dr. Romero added, “ROI-C already requires fewer steps than most other systems on the market, and the addition of titanium coating is a great enhancement. Having the radiolucency of PEEK combined with the roughness of the plasma sprayed titanium all in one implant is beneficial.”
The ROI-C Titanium-Coated Implant System offers a porous plasma-sprayed titanium coating on both the superior and inferior surfaces of the radiolucent PEEK-OPTIMA® cage. Like all ROI-C Cervical Cage implants, the titanium-coated version is available in four footprints, five heights, and in both an anatomic dome and flat lordotic implant design. With ROI-C’s inline implantation method, an angled approach is not necessary to deploy the VerteBRIDGE plating. This allows for a small incision and a streamlined approach, which may be especially beneficial at the superior and inferior levels of the cervical spine.
Christophe Lavigne, President and CEO of LDR, commented, “We are pleased to offer surgeons a new option for our already best-in-class ROI-C Cervical Cage system, which accounts for a majority of the over 100,000 implantations of VerteBRIDGE plating worldwide. The patented in-line plating technology makes optimal use of a minimally-invasive surgical technique and, consistent with LDR’s Minimal Implant Volume (MIVo™) surgery philosophy, gains stability while leaving less hardware in the patient than would a conventional discectomy and fusion with an anterior cervical plate and screws. As a global cervical spine solution provider, LDR continues to introduce innovative products to accommodate the needs of a quickly changing market, and we are excited to add ROI-C Titanium-Coated Cages to our growing list of products. In support of our strategic focus on cervical motion preservation with the Mobi-C® Cervical Disc, the ROI-C Cervical Cage represents an attractive option for patients not indicated for cervical disc who may benefit from cervical fusion instead.”
ROI-C Cervical Cage
The ROI-C Implant System & ROI-C Titanium-Coated Implant System are 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 ROI-C Implant System & ROI-C Titanium-Coated Implant System implants are to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system. The ROI-C Implant System & ROI-C Titanium-Coated Implant System have been designed to be compatible with optional supplemental fixation specific for the system. The two-piece VerteBRIDGE Anchoring Plate is available and may be used to affix the ROI-C Implant System & ROI-C Titanium-Coated Implant System implants to the underlying vertebral bone allowing for the option of a stand-alone construct. Additional or other supplemental fixation may be used, as patient needs dictate.
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.
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 can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. 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, sales of its ROI-C Implant System & ROI-C Titanium-Coated Implant System, 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 23, 2016, and in LDR’s other filings with the SEC. LDR disclaims any responsibility to update any forward-looking statements.
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