Shoulder Innovations Announces Full Commercial Launch of the InSet™ 70 Humeral Stem
Shoulder Innovations (NYSE:SI) has announced the full commercial launch of its InSet™ 70 Humeral Stem across the United States, expanding its I-Series humeral stem product line. The new implant, complementing the InSet™ 95 launched in 2024, is designed for both anatomic and reverse shoulder arthroplasty procedures.
The InSet™ 70 is indicated for various clinical applications, including non-inflammatory degenerative joint disease, rheumatoid and traumatic arthritis, and functional deformity correction. For reverse procedures, it's also indicated for irreparable cuff tears with or without arthritis and device revisions with sufficient bone stock. The device offers bone-sparing utility while maintaining excellent initial fixation and simple workflow.
Shoulder Innovations (NYSE:SI) ha annunciato il lancio commerciale completo del suo InSet™ 70 Humeral Stem su tutto il territorio degli Stati Uniti, ampliando la linea di sterni omerali della serie I. Il nuovo impianto, che completa l’InSet™ 95 introdotto nel 2024, è progettato sia per procedure di artroplastica della spalla anatomica sia per l’arthroplastica inversa.
L’InSet™ 70 è indicato per molteplici applicazioni cliniche, tra cui malattia degenerativa non infiammatoria delle articolazioni, artrite reumatoide e artrite traumatica, e correzione di deformità funzionale. Per le procedure inverse, è indicato anche per lacrime irreparabili della cuffia dei rotatori con o senza artrite e revisioni dell’impianto con sufficiente stock osseo. Il dispositivo offre una conservazione ossea abbinata a una eccellente fissazione iniziale e a un flusso di lavoro semplice.
Shoulder Innovations (NYSE:SI) ha anunciado el lanzamiento comercial completo de su InSet™ 70 Humeral Stem en todos los Estados Unidos, ampliando su línea de tallos humerales de la serie I. El nuevo implante, que complementa al InSet™ 95 lanzado en 2024, está diseñado para procedimientos de artroplastia de hombro anatómica y reversa.
El InSet™ 70 está indicado para diversas aplicaciones clínicas, incluyendo enfermedad articular degenerativa no inflamatoria, artritis reumatoide y artritis traumática, y corrección de deformidades funcionales. Para procedimientos reversos, también está indicado para desgarros irreparables de la manguito rotador con o sin artritis y revisiones del dispositivo con suficiente stock óseo. El dispositivo ofrece conservación ósea manteniendo una excelente fijación inicial y un flujo de trabajo sencillo.
Shoulder Innovations (NYSE:SI)가 미국 전역에서 InSet™ 70 Humeral Stem의 전면 상용화를 발표하여 I-시리즈 어깨 줄기 제품군을 확장했습니다. 2024년에 출시된 InSet™ 95를 보완하는 새로운 임플란트로, 해부학적 및 역방향 어깨관절 성형술 모두에 설계되었습니다.
InSet™ 70은 다양한 임상 적용에 적합하며, 비염증성 퇴행성 관절질환, 류마티스 및 외상성 관절염, 기능적 기형 교정을 포함합니다. 역방향 절차의 경우, 아르트로시스가 있는지 여부와 무관하게 견갑근 힘줄 파열이 회복 불가능한 경우 및 충분한 뼈 재고를 가진 부위의 디바이스 재수술에 대해서도 적응증이 있습니다. 이 기기는 뼈를 보존하면서도 탁월한 초기 고정과 간단한 워크플로우를 제공합니다.
Shoulder Innovations (NYSE:SI) a annoncé le lancement commercial complet de son InSet™ 70 Humeral Stem à travers les États-Unis, élargissant sa gamme de tiges humérales de la série I. Le nouvel implant, complétant l’InSet™ 95 lancé en 2024, est conçu pour les procédures d’arthroplastie de l’épaule anatomique et inverse.
L’InSet™ 70 est indiqué pour diverses applications cliniques, notamment les maladies articulaires dégénératives non inflammatoires, l’arthrite rhumatoïde et l’arthrite traumatique, et la correction des déformations fonctionnelles. Pour les procédures inverses, il est également indiqué pour les déchirures irréparables de la coiffe des rotateurs avec ou sans arthrite et les révisions d’appareils avec un stock osseux suffisant. Le dispositif offre une conservation de l’os tout en assurant une excellente fixation initiale et une procédure de travail simple.
Shoulder Innovations (NYSE:SI) hat die vollständige kommerzielle Markteinführung seines InSet™ 70 Humeral Stem in den gesamten Vereinigten Staaten angekündigt und damit die I-Series-Humerus-Stämme erweitert. Das neue Implantat ergänzt den im Jahr 2024 eingeführten InSet™ 95 und ist sowohl für anatomische als auch für reverse Schultergelenk-Operationen konzipiert.
Der InSet™ 70 ist für verschiedene klinische Anwendungen vorgesehen, darunter nicht-entzündliche degenerative Gelenkerkrankungen, rheumatoide und traumatische Arthritis sowie funktionelle Deformitätskorrekturen. Für Reverse-Verfahren gilt es auch bei irreparablen Rotatorenmanschettenrissen mit oder ohne Arthritis sowie Revisionen des Geräts bei ausreichendem Knochenvorrat. Das Gerät bietet knochenersparende Eigenschaften bei gleichzeitig guter initialer Fixierung und einem einfachen Arbeitsablauf.
Shoulder Innovations (NYSE:SI) أعلنت عن الإطلاق التجاري الكامل لـ InSet™ 70 Humeral Stem في جميع أنحاء الولايات المتحدة، موسعة خط جذوع الوضع الكتفي من سلسلة I. يتميز الزرعة الجديدة، التي تكمل InSet™ 95 الذي أُطلق في 2024، بتصميم لإجراءات تركيب الكتف بمسارات تشريحية ومقلوبة.
يُشير InSet™ 70 إلى عدة تطبيقات سريرية، بما في ذلك الأمراض المفصلية التنكسية غير الالتهابية، الروماتيزم والتهاب المفاصل الناتج عن الإصابات، وتصحيح تشوه وظيفي. وبالنسبة للإجراءات العكسية، فهو مُشير أيضًا للتمزقات غير القابلة للإصلاح في الحافظة الجراحية مع وجود أو بدون التهاب مفاصل، ولإعادة تثبيت الجهاز مع وجود مخزون عظمي كافٍ. يوفر الجهاز حفاظًا على العظم مع تثبيت ابتدائي ممتاز وسير عمل بسيط.
Shoulder Innovations (NYSE:SI)宣布在全美范围内全面商业发布其InSet™ 70 Humeral Stem,扩展了I-Series肱骨干 stem 产品线。该新植入物与2024年推出的InSet™ 95相辅相成,设计用于解剖肩关节置换和反向肩关节置换手术。
InSet™ 70适用于多种临床应用,包括非炎性退行性关节疾病、风湿性以及创伤性关节炎及功能畸形矫正。在反向置换手术中,若肩袖撕裂不可修复(有无关节炎)以及在具有足够骨量时的器械置换均适用。该器械在保留骨量的同时,提供出色的初期固定和简便的工作流程。
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Insights
SI's new InSet™ 70 Humeral Stem strengthens portfolio with bone-sparing alternative, addressing broad clinical applications while maintaining workflow benefits.
Shoulder Innovations' full commercial launch of the InSet™ 70 Humeral Stem represents a strategic expansion of their I-Series product line. This launch comes ahead of schedule nationwide, demonstrating operational efficiency in bringing new technology to market. The InSet™ 70 complements the longer InSet™ 95 stem launched in 2024, offering similar fixation capabilities but in a bone-preserving form factor.
The product's clinical versatility is particularly noteworthy, with indications covering both anatomic and reverse shoulder arthroplasty procedures. This dual-functionality addresses multiple conditions including osteoarthritis, avascular necrosis, rheumatoid arthritis, traumatic arthritis, and functional deformity correction. For reverse procedures, it extends to irreparable rotator cuff tears and revision surgeries where sufficient bone stock remains.
From a market positioning perspective, the InSet™ 70's bone-sparing utility while maintaining the workflow and fixation benefits of the larger stem creates a compelling value proposition. The endorsements from orthopedic surgeons Dr. Galen Kam and Dr. Matthew Pifer highlight the product's fixation capabilities and potential for improved biomechanics - critical selling points for surgeon adoption. This launch strengthens SI's shoulder arthroplasty portfolio at a time when demographic trends continue to drive growth in the shoulder replacement market.
Expansion of the I-Series Humeral Stem Product Line Further Strengthens Robust Shoulder Arthroplasty Portfolio
"The InSet™ 70 complements our broad portfolio of advanced shoulder implant solutions, and we are excited to bring it to market across
Indicated for use in both anatomic and reverse shoulder arthroplasty, the InSet™ 70 addresses a broad range of clinical needs, including non-inflammatory degenerative joint disease such as osteoarthritis and avascular necrosis, rheumatoid and traumatic arthritis, and correction of functional deformity. In reverse procedures, it is further indicated for irreparable cuff tears with or without arthritis, as well as for revision of other devices when sufficient bone stock remains.
"Featuring the same excellent initial fixation and simple workflow as the longer InSet™ 95, the InSet™ 70 offers the added benefit of bone-sparing utility, making it a compelling offering in the shoulder care space," said Galen Kam, MD. "Essentially, this product affords all the advantages of a larger stem in a smaller, bone-preserving form factor."
"The InSet™ 70 provides my patients with superb humeral fixation within the reverse total shoulder platform, delivering optimized biomechanics and supporting improved shoulder function," said Matthew Pifer, MD.
About Shoulder Innovations
Shoulder Innovations is a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market, with a current offering of advanced implant systems for shoulder arthroplasty. These systems are a core element of Shoulder Innovations' ecosystem, which is designed to improve core components of shoulder surgical care – preoperative planning, implant design and procedural efficiency – to benefit each stakeholder in the care chain. Shoulder Innovations' ecosystem is also comprised of enabling technologies, efficient instrument systems, specialized support and surgeon-to-surgeon collaboration. Together, these elements seek to address the long-standing clinical and operational challenges in the shoulder surgical care market by delivering predictable outcomes, procedural simplicity, and efficiency across all sites of care.
Contact
Brian Johnston or Sam Bentzinger
Gilmartin Group LLC
ir@shoulderinnovations.com
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SOURCE Shoulder Innovations