LDR Announces First Surgeries Using ROI-C Cervical Cage With Titanium Coating

LDR Holding Corporation has announced the initial implantations of its 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, Fla., and Dr. Neil Romero, a board-certified orthopedic surgeon specializing in minimally invasive spine surgery and arthroplasty in Lafayette, La.
 
“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,” Giovanini said.
 
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, according to LDR Holding Corporation. 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.
 
“We are pleased to offer surgeons a new option for our ROI-C Cervical Cage system, which accounts for a majority of the over 100,000 implantations of VerteBRIDGE plating worldwide,” said Christophe Lavigne, president and CEO of LDR. “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.  We are excited to add ROI-C Titanium-Coated Cages to our 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.”
 
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.
 
“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,” Romero said.
 
LDR Holding Corporation designs and commercializes proprietary surgical spinal treatment technologies. The company’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 U.S. Food and Drug Administration (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.