A little more than two months after LDR (Austin, Texas) received FDA 510(k) approval for its ROI-A partial vertebral body replacement tool, the company reported last week that it would put the device out on the market immediately.
"Up until [last week] the device was in exclusive use with our designing team," James Burrows, VP of product commercialization, told Medical Device Daily.
The stand-alone implant, known as ROI-A, is a partial vertebral (front of spine) replacement device used to stabilize the spine. It is made of PEEK-Optima, a high-density plastic, and has an upper and lower metal clip, which deploys through the cage of the device and affixes to the vertebral body above and below, acting like a molly screw that secures both sides of a wall.
The surgical technique is a direct anterior approach, with the curved anchoring plates inserted along the sagittal plane, thus requiring no additional exposure to the vertebral bodies. It also includes Tantalum markers for verification of implant positioning.
The system is comprised of multiple footprint sizes, lordotic angles and heights for optimized fit per anatomical requirements. An inserter holds the implant, protecting vascular structures and guiding the anchoring plates during insertion.
"The ROI-A has an advantage over most devices that treat lumbar spine," Burrows said. "With other devices — more specifically, with lumbar plating — erosion of vessels is at risk, because there is a higher risk in exposure. But because of the unique positioning of ROI-A you can place those anchors in at an angle without extended exposure to the vessels."
In addition, the ROI-A leaves no hardware protruding in the front of the spine, making mobility safer for patients and optimizing stability.
Since launching the ROI-A, more than 75 procedures have been performed, with extremely positive feedback from the surgeons.
Charles Gordon, MD, of Gordon Spine Associates (Tyler, Texas), said, "Overall, the innovative anchoring technology combined with well-designed instrumentation and the straight anterior approach provides a very effective solution for lumbar partial vertebral body replacement."
Burrows told MDD, "This is by far the easiest and best product release I've ever been involved with. We've had nothing but overwhelming positive response."
He again touted the device's ability to carefully reduce exposure, limiting the possibility of vessel damage.
LDR's discs are not the only ones likely to be in competition with fusion procedures.
Medtronic (Minneapolis) has its Prestige artificial cervical disc — made by the company's Medtronic Spinal and Biologics (Memphis, Tennessee) business unit which is poised for approval and roll-out, along with the company's Bryan Cervical Device, which has received an FDA panel's recommendation for approval.
And SpinalMotion (Mountain View, California) reported "significant progress" in U.S.-based investigational device exemption clinical trials of its Kineflex lumbar disc and Kineflex|C cervical disc implants (MDD; Sept. 28, 2006).
LDR is a private company that most recently went through a Series C financing of $25 million. Telegraph Hill Partners led the investment, along with original investors Austin Ventures, Rothschild Private Equity and PTV Sciences (MDD, Sept. 14, 2007).
The company's products include Mobi-L (MobiDisc) for Lumbar Artificial Spine, Mobia-C Cervical Artificial Disc, Easyspine Posterior Pedicle Screw System, Mc+ PEEK Modular Cervical Fusion System, ROI PEEK Posterior Lumbar Fusion Device, ROI-T PEEK Transforaminal Lumbar Fusion Device, ROI-C Apeek Cervical Fusion Device, BF+ and BF+ (Ph) Synthetic Bone Substitute.
The company combined two separate organizations: French-based LDR Medical and U.S.-based LDR Spine, to create LDR Holding Corp. Privately held LDR said it is an innovator in both non-fusion and fusion spinal implants.
The new structure was created to better align company strategies and to heighten LDR's visibility as a global, integrated company within the spine industry.
LDR was founded in 2000 by eperienced spine executives based in Troyes, France, and now has sales in more than 26 countries worldwide.