SOURCE: Aesculap

November 03, 2016 11:48 ET

Inaugural Lumbar Total Disc Replacement Summit Yields Surgeon Consensus on Lumbar TDR as a Standard of Care for Lumbar DDD

Lumbar TDR is a Well-Documented Surgical Treatment Alternative to Spinal Fusion

CENTER VALLEY, PA--(Marketwired - November 03, 2016) - Prior to the 31st Annual North American Spine Society (NASS) meeting in Boston, MA last week, a group of leading spine surgeons came together at the inaugural Lumbar Total Disc Replacement Summit. The goal of the Summit was to drive consensus on Lumbar Total Disc Replacement (TDR) as a standard of care for lumbar DDD in the active patient subpopulation and to ultimately influence payers to expand coverage of the procedure. The surgeons recognized motion-preserving TDR as a well-studied surgical treatment alternative to spinal fusion and collaborated on a review of the long-term evidence in support of lumbar TDR.

The 19-surgeon panel developed a general consensus on the patient groups who, based on the published long-term evidence, should have access to this procedure through their insurance companies. The panel cited lumbar TDR as the most studied spinal procedure with outcomes exceeding those of fusion, which is currently treated as the standard of care for this patient population.

Despite significant evidence available on the procedure, many insurance carriers have shown reluctance to adding lumbar TDR to their covered benefits. "There is a general lack of understanding by the payers of how well lumbar TDR has been studied and how positive the outcomes have been," said Lynn Miller, MD, a neurosurgeon whose practice is focused on motion preservation in the Twin Cities. "Our panel group agreed that lumbar TDR does not add cost to the payer. We don't understand why they are so reluctant to cover something where the patient benefit has been thoroughly demonstrated."

The surgeon panel plans to publish the outcome of their discussion and share with payers in their regions to demonstrate how surgeons would responsibly utilize TDR as a treatment alternative to fusion.

Plans for the second Lumbar TDR Summit are underway for Spring 2017. The panel is looking for additional surgeons to join the movement and increase momentum of this procedure aimed at improving quality of life for chronic low back pain patients. The inaugural Lumbar TDR Summit was funded in part by Aesculap Implant Systems, LLC. The company is currently closing out a seven-year IDE study on its lumbar TDR device, activL® Artificial Disc.

Cornerstone Research Group was commissioned to employ a modified-Delphi process to reach consensus on the responsible use of TDR. The firm is currently pooling the existing five-year evidence on lumbar TDR from six randomized controlled trials into a meta-analysis.

Patients suffering from debilitating low back pain who have exhausted their non-surgical treatment options without finding relief for their pain often seek surgical procedures to stabilize their low back, thereby reducing pain and getting them back to a favorable quality of life. While the vast majority of spine surgeons first offer a spinal fusion to address this problem, long-term evidence demonstrates that for some patients, TDR is a better option because it comes closer to maintaining the natural physiologic movement of the healthy human back. In five-year studies, total disc replacement has demonstrated a threefold reduction from fusion in the rate of further degenerative disease at other motion segments in the spine.

About Aesculap Implant Systems, LLC

Aesculap Implant Systems, LLC, part of the B. Braun group of companies, is part of a 175-year-old global organization focused on meeting the needs of the changing healthcare environment. Through close collaboration with its customers, Aesculap Implant Systems develops advanced spine and orthopaedic implant technologies to treat complex disorders of the spine, hip and knee. Aesculap Implant Systems strives to deliver products and services that improve the quality of patients' lives. For more information, call 800-234-9179 or visit aesculapimplantsystems.com.

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    Aesculap Implant Systems, LLC
    office: 610-984-9242
    email: judy.marushak@aesculap.com