Globus Medical Launches ADIRA™ XLIF™ Plate System
Globus Medical (NYSE: GMED) has launched the ADIRA™ XLIF™ Plate System, marking a significant milestone in its integration roadmap. This system, compatible with Globus and NuVasive interbody spacers, aims to enhance lateral spine surgery procedures. Key features include:
1. Simplified insertion workflows
2. Rigid coupling mechanism for plate-spacer alignment
3. Compatibility with bone screws and lateral MIS anchors
4. Versatility in bone fixation options and interbody spacer types
The ADIRA™ system is designed to work with various interbody spacers, including RISE-L™, Modulus™ XLIF™, Hedron L™, Cohere™ XLIF™, TransContinental™, and CoRoent™ XLIF™. It's indicated for use in treating thoracolumbar spinal instability and as an adjunct to fusion in specific conditions.
Globus Medical (NYSE: GMED) ha lanciato il Sistema di Piastra ADIRA™ XLIF™, un traguardo significativo nella sua roadmap di integrazione. Questo sistema, compatibile con gli spaziatori intersomatici di Globus e NuVasive, mira a migliorare le procedure chirurgiche per la colonna vertebrale laterale. Le caratteristiche principali includono:
1. Workflow di inserimento semplificati
2. Meccanismo di accoppiamento rigido per l'allineamento piastra-spazatore
3. Compatibilità con viti ossee e ancoraggi MIS laterali
4. Versatilità nelle opzioni di fissazione ossea e nei tipi di spaziatori intersomatici
Il sistema ADIRA™ è progettato per funzionare con vari spaziatori intersomatici, tra cui RISE-L™, Modulus™ XLIF™, Hedron L™, Cohere™ XLIF™, TransContinental™, e CoRoent™ XLIF™. È indicato per il trattamento dell'instabilità spinale toracolombare e come complemento alla fusione in specifiche condizioni.
Globus Medical (NYSE: GMED) ha lanzado el Sistema de Placa ADIRA™ XLIF™, marcando un hito significativo en su hoja de ruta de integración. Este sistema, compatible con los espaciadores intersomáticos de Globus y NuVasive, tiene como objetivo mejorar los procedimientos quirúrgicos de la columna vertebral lateral. Las características clave incluyen:
1. Flujos de trabajo de inserción simplificados
2. Mecanismo de acoplamiento rígido para la alineación pletina-espaciador
3. Compatibilidad con tornillos óseos y anclajes MIS laterales
4. Versatilidad en opciones de fijación ósea y tipos de espaciadores intersomáticos
El sistema ADIRA™ está diseñado para trabajar con varios espaciadores intersomáticos, incluidos RISE-L™, Modulus™ XLIF™, Hedron L™, Cohere™ XLIF™, TransContinental™ y CoRoent™ XLIF™. Está indicado para el tratamiento de la inestabilidad toracolumbar de la columna y como un adjunto a la fusión en condiciones específicas.
글로부스 메디컬 (NYSE: GMED)는 ADIRA™ XLIF™ 플레이트 시스템을 출시하여 통합 로드맵의 중요한 이정표를 세웠습니다. 이 시스템은 글로부스와 누바세이브 인터바디 스페이서와 호환되어 측면 척추 수술 절차를 향상시키는 것을 목표로 합니다. 주요 특징은 다음과 같습니다:
1. 간소화된 삽입 작업 흐름
2. 플레이트-스페이서 정렬을 위한 강체 연결 메커니즘
3. 뼈 나사 및 측면 미니 침습적 앵커와의 호환성
4. 뼈 고정 옵션 및 인터바디 스페이서 유형의 다용성
ADIRA™ 시스템은 RISE-L™, Modulus™ XLIF™, Hedron L™, Cohere™ XLIF™, TransContinental™, CoRoent™ XLIF™ 등 다양한 인터바디 스페이서와 함께 작업하도록 설계되었습니다. 흉요추 척추 불안정성 치료와 특정 조건에서의 융합 보조로 사용이 권장됩니다.
Globus Medical (NYSE: GMED) a lancé le Système de Plaque ADIRA™ XLIF™, marquant une étape importante dans sa feuille de route d'intégration. Ce système, compatible avec les espaçateurs intersomatiques de Globus et NuVasive, vise à améliorer les procédures de chirurgie de la colonne vertébrale latérale. Les caractéristiques clés comprennent :
1. Flux de travail d'insertion simplifiés
2. Mécanisme de couplage rigide pour l'alignement plaque-espaçateur
3. Compatibilité avec des vis osseuses et des ancres MIS latérales
4. Polyvalence dans les options de fixation osseuse et les types d'espacateurs intersomatiques
Le système ADIRA™ est conçu pour fonctionner avec divers espaçateurs intersomatiques, notamment RISE-L™, Modulus™ XLIF™, Hedron L™, Cohere™ XLIF™, TransContinental™ et CoRoent™ XLIF™. Il est indiqué pour le traitement de l'instabilité thoraco-lombaire de la colonne vertébrale et comme complément à la fusion dans des conditions spécifiques.
Globus Medical (NYSE: GMED) hat das ADIRA™ XLIF™ Plattensystem auf den Markt gebracht, was einen bedeutenden Meilenstein in seiner Integrationsroadmap darstellt. Dieses System, das mit Globus- und NuVasive-Seltenkörperspacer kompatibel ist, zielt darauf ab, die seitlich invasive Wirbelsäulenchirurgie zu verbessern. Zu den wichtigsten Merkmalen gehören:
1. Vereinfachte Einführungsabläufe
2. Rigid-Kopplungsmechanismus für die Platten-Spacer-Ausrichtung
3. Kompatibilität mit Knochenschrauben und seitlichen MIS-Ankern
4. Vielseitigkeit bei den Optionen zur Knochenfixierung und den Typen der zwischenliegenden Spacer
Das ADIRA™-System wurde entwickelt, um mit verschiedenen zwischenliegenden Spacern zu arbeiten, darunter RISE-L™, Modulus™ XLIF™, Hedron L™, Cohere™ XLIF™, TransContinental™ und CoRoent™ XLIF™. Es wird zur Behandlung von thorakolumbaler Wirbelsäuleninstabilität und als Zusatz zur Fusion bei bestimmten Bedingungen angezeigt.
- Launch of ADIRA™ XLIF™ Plate System, expanding lateral interbody portfolio
- Compatibility with both Globus and NuVasive interbody spacers, enhancing product integration
- Versatile system offering procedural options for bone fixation and interbody spacer types
- Potential to improve construct stability in lateral spine surgery procedures
- None.
The launch of Globus Medical's ADIRA™ XLIF™ Plate System represents a significant advancement in lateral spine surgery. This system's compatibility across the company's expanded lateral interbody portfolio demonstrates strategic product integration following recent acquisitions. The system's key features, including simplified insertion workflows and a rigid coupling mechanism, address critical needs in spinal fusion procedures.
From a market perspective, this launch could strengthen Globus Medical's position in the competitive spine surgery device market. The system's versatility in bone fixation options and interbody spacer types may appeal to a broader range of surgeons, potentially driving adoption and market share growth. However, the impact on revenue will depend on pricing strategy and market acceptance, which are not disclosed in the announcement.
The ADIRA™ XLIF™ Plate System introduces notable clinical benefits for lateral spine surgery. The rigid coupling mechanism enhances construct stability, which is important for successful spinal fusion outcomes. The system's compatibility with both bone screws and lateral MIS anchors offers valuable procedural flexibility, allowing surgeons to tailor the approach to individual patient needs.
The ability to attach plates in situ or on the back table for static single-construct insertion is a significant workflow improvement. This feature could potentially reduce operating time and improve efficiency in the OR. However, long-term clinical data will be necessary to fully evaluate the system's impact on patient outcomes and fusion rates compared to existing solutions.
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
FAQ
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