AUDUBON, Pa., Aug. 21, 2024 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, today announced the commercial launch of the ADIRA™ XLIF™ Plate System, the Company’s first product launch compatible across its expanded lateral interbody portfolio.
“This launch represents an important milestone in our integration roadmap,” said David Hole, president of Spine at Globus Medical. “Through the system’s ability to be paired with our industry-leading Globus and NuVasive interbody spacers, ADIRA™ demonstrates our continued commitment to accelerated procedural innovation in lateral spine surgery.”
The ADIRA™ XLIF™ Plate System refines lateral plating by offering simplified insertion workflows and a rigid coupling mechanism to confidently align plates over interbody spacers to enhance construct stability. Compatible with bone screws and lateral MIS anchors, the ADIRA™ XLIF™ Plate System offers procedural versatility for bone fixation options as well as interbody spacer types.
“This system provides both efficiency and confidence in cases that require stand-alone or supplemental lateral plating,” said Dr. Anthony Bozzio, MD, Bay Street Orthopaedics & Spine. “Whether attaching the plate in situ or on the back table for static single-construct insertion, the system provides me with streamlined, rigid plate-interbody connection.”
Procedurally integrated throughout the Globus Medical lateral portfolio, ADIRA™ plates are designed to rigidly thread into RISE-L™, Modulus™ XLIF™, Hedron L™, Cohere™ XLIF™, TransContinental™, and CoRoent™ XLIF™ interbody spacers, to help reduce the risk of spacer migration while accommodating varied patient anatomy and surgeon preferences.
ADIRA™ Plate-Spacer Assemblies and FDA Cleared Indications
ADIRA™ plates may be assembled to lateral lumbar interbody fusion devices (HEDRON L™, TransContinental™, RISE-L™, Modulus™ XLIF™, Cohere™ XLIF™, or CoRoent™) with an alignment screw to create an ADIRA™ Plate-Spacer assembly, to provide structural stability in skeletally mature individuals following discectomy. The plate-spacer assembly is used with bone screws and/or lateral anchors.
ADIRA™ Lateral Plate System
The ADIRA™ 2-Hole and 4-Hole Plates, when used with screws only, are intended for use in the treatment of thoracolumbar (T1-L5) spinal instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spinal surgery.
The ADIRA™ 1-Hole Plate is intended to stabilize allograft or autograft at one level (T1-L5), aiding in spinal fusion and to provide temporary stabilization and augment development of a spinal fusion. It may be used alone or with other anterior, lateral, anterolateral, or posterior spinal systems. The device is not intended for load bearing applications.
ADIRA™ Plate-Spacer Assemblies
ADIRA™ Plates may be assembled to a lateral lumbar interbody fusion device (HEDRON L™, TransContinental™, RISE-L™, Modulus™ XLIF™, CoRoent™, or Cohere™ XLIF Spacers) to create a plate-spacer assembly. When assembled to HEDRON L™, TransContinental™, or RISE-L™ Spacers, the plate-spacer assembly is indicated for use at one or more levels of the lumbosacral spine (L1-L5), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. When ADIRA™ Plates are assembled to Modulus™ XLIF™, CoRoent™, or Cohere™ XLIF™ Spacers, the plate-spacer assembly takes on the indications of the interbody device.
ADIRA™ Plate-Spacers are intended to be used with screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, the 2-Hole or 4-Hole Plate-Spacers are intended for stand-alone use in patients with DDD at one or two levels only when <20° lordotic implants are used with two or four screws, respectively.
ADIRA™ Plate-Spacers are to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
About Globus Medical, Inc.
Globus Medical is a leading musculoskeletal company based in Audubon, PA, relentlessly focused on developing technologies, procedures and products that solve unmet clinical needs, promote healing in patients, and change lives around the globe. Additional information can be accessed at www.globusmedical.com.
Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, the risks and costs associated with the integration of, and the ability of Globus Medical and NuVasive to integrate, their businesses successfully and to achieve anticipated synergies, health epidemics, pandemics and similar outbreaks, including the COVID-19 pandemic, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.
Investor contact:
Brian Kearns
610-930-1800
investors@globusmedical.com
Media contact:
Moran Chavez
media@globusmedical.com
