AUDUBON, Pa., Aug. 21, 2024 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE: GMED), a number one musculoskeletal options firm, at the moment introduced the business launch of the ADIRA™ XLIF™ Plate System, the Firm’s first product launch appropriate throughout its expanded lateral interbody portfolio.
“This launch represents an necessary milestone in our integration roadmap,” mentioned David Gap, president of Backbone at Globus Medical. “By way of the system’s capacity to be paired with our industry-leading Globus and NuVasive interbody spacers, ADIRA™ demonstrates our continued dedication to accelerated procedural innovation in lateral spine surgical procedure.”
The ADIRA™ XLIF™ Plate System refines lateral plating by providing simplified insertion workflows and a inflexible coupling mechanism to confidently align plates over interbody spacers to boost assemble stability. Appropriate with bone screws and lateral MIS anchors, the ADIRA™ XLIF™ Plate System affords procedural versatility for bone fixation choices in addition to interbody spacer sorts.
“This method supplies each effectivity and confidence in instances that require stand-alone or supplemental lateral plating,” mentioned Dr. Anthony Bozzio, MD, Bay Road Orthopaedics & Backbone. “Whether or not attaching the plate in situ or on the again desk for static single-construct insertion, the system supplies me with streamlined, inflexible plate-interbody connection.”
Procedurally built-in all through 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 assist cut back the chance of spacer migration whereas accommodating different affected person anatomy and surgeon preferences.
ADIRA™ Plate-Spacer Assemblies and FDA Cleared Indications
ADIRA™ plates could also be assembled to lateral lumbar interbody fusion units (HEDRON L™, TransContinental™, RISE-L™, Modulus™ XLIF™, Cohere™ XLIF™, or CoRoent™) with an alignment screw to create an ADIRA™ Plate-Spacer meeting, to offer structural stability in skeletally mature people following discectomy. The plate-spacer meeting is used with bone screws and/or lateral anchors.
ADIRA™ Lateral Plate System
The ADIRA™ 2-Gap and 4-Gap Plates, when used with screws solely, are meant to be used within the remedy of thoracolumbar (T1-L5) spinal instability because of fracture (together with dislocation and subluxation), tumor, degenerative disc illness (DDD, outlined as again ache of discogenic origin with degeneration of the disc confirmed by affected person historical past and radiographic research), scoliosis, kyphosis, lordosis, spinal stenosis, or failed earlier spinal surgical procedure.
The ADIRA™ 1-Gap Plate is meant to stabilize allograft or autograft at one stage (T1-L5), aiding in spinal fusion and to offer short-term stabilization and increase improvement of a spinal fusion. It might be used alone or with different anterior, lateral, anterolateral, or posterior spinal methods. The machine will not be meant for load bearing functions.
ADIRA™ Plate-Spacer Assemblies
ADIRA™ Plates could also be assembled to a lateral lumbar interbody fusion machine (HEDRON L™, TransContinental™, RISE-L™, Modulus™ XLIF™, CoRoent™, or Cohere™ XLIF Spacers) to create a plate-spacer meeting. When assembled to HEDRON L™, TransContinental™, or RISE-L™ Spacers, the plate-spacer meeting is indicated to be used at a number of ranges of the lumbosacral spine (L1-L5), as an adjunct to fusion in sufferers with the next indications: degenerative disc illness (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed earlier fusion (pseudarthrosis). DDD is outlined as discogenic again ache with degeneration of the disc confirmed by historical past and radiographic research. These sufferers ought to be skeletally mature and have had not less than six (6) months of non-operative remedy. When ADIRA™ Plates are assembled to Modulus™ XLIF™, CoRoent™, or Cohere™ XLIF™ Spacers, the plate-spacer meeting takes on the indications of the interbody machine.
ADIRA™ Plate-Spacers are meant for use with screws and/or anchors which accompany the implants. These units are meant to be used with supplemental fixation (e.g. aspect screws or posterior fixation). As well as, the 2-Gap or 4-Gap Plate-Spacers are meant for stand-alone use in sufferers with DDD at one or two ranges solely when <20° lordotic implants are used with two or 4 screws, respectively.
ADIRA™ Plate-Spacers are to be full of autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
About Globus Medical, Inc.
Globus Medical is a number one musculoskeletal firm primarily based in Audubon, PA, relentlessly targeted on growing applied sciences, procedures and merchandise that remedy unmet scientific wants, promote therapeutic in sufferers, and alter lives across the globe. Extra info will be accessed at www.globusmedical.com.
Protected Harbor Statements
All statements included on this press launch aside from statements of historic reality are forward-looking statements and could also be recognized by their use of phrases comparable to “imagine,” “could,” “would possibly,” “may,” “will,” “purpose,” “estimate,” “proceed,” “anticipate,” “intend,” “anticipate,” “plan” and different comparable phrases. These forward-looking statements are primarily based on our present assumptions, expectations and estimates of future occasions and traits. Ahead-looking statements are solely predictions and are topic to many dangers, uncertainties and different elements that will have an effect on our companies and operations and will trigger precise outcomes to vary materially from these predicted. These dangers and uncertainties embrace, however are usually not restricted to, the dangers and prices related to the mixing of, and the flexibility of Globus Medical and NuVasive to combine, their companies efficiently and to attain anticipated synergies, well being epidemics, pandemics and comparable outbreaks, together with the COVID-19 pandemic, elements affecting our quarterly outcomes, our capacity to handle our development, our capacity to maintain our profitability, demand for our merchandise, our capacity to compete efficiently (together with with out limitation our capacity to persuade surgeons to make use of our merchandise and our capacity to draw and retain gross sales and different personnel), our capacity to quickly develop and introduce new merchandise, our capacity to develop and execute on profitable enterprise methods, our capacity to adjust to legal guidelines and laws which can be or could grow to be relevant to our companies, our capacity to safeguard our mental property, our success in defending authorized proceedings introduced towards us, traits within the medical machine {industry}, common financial situations, and different dangers. For a dialogue of those and different dangers, uncertainties and different elements that would have an effect on our outcomes, it’s best to seek advice from the disclosure contained in our most up-to-date annual report on Kind 10-Ok filed with the Securities and Alternate Fee, together with the sections labeled “Danger Elements” and “Cautionary Observe Regarding Ahead-Trying Statements,” and in our Kinds 10-Q, Kinds 8-Ok and different filings with the Securities and Alternate Fee. These paperwork can be found at www.sec.gov. Furthermore, we function in an evolving surroundings. New danger elements and uncertainties emerge now and again and it isn’t attainable for us to foretell all danger elements and uncertainties, nor can we assess the impression of all elements on our enterprise or the extent to which any issue, or mixture of things, could trigger precise outcomes to vary materially from these contained in any forward-looking statements. Given these dangers and uncertainties, readers are cautioned to not place undue reliance on any forward-looking statements. Ahead-looking statements contained on this press launch converse solely as of the date of this press launch. We undertake no obligation to replace any forward-looking statements because of new info, occasions or circumstances or different elements arising or coming to our consideration after the date hereof.
Investor contact:
Brian Kearns
610-930-1800
buyers@globusmedical.com
Media contact:
Moran Chavez
media@globusmedical.com
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