SI-BONE, Inc. Receives 510(k) Clearance and FDA Breakthrough Device Designation for Pelvic Fracture Fixation System
SI-BONE, Inc. (Nasdaq: SIBN) has received FDA 510(k) clearance and Breakthrough Device Designation for its iFuse TORQ TNT™ Implant System (TNT). This next-generation technology is designed for pelvic fragility fracture fixation and sacroiliac joint fusion. The TNT system features a porous threaded implant capable of spanning the posterior pelvis, addressing the specific needs of the sacrum and ilium.
The FDA recognized TNT's potential to provide more effective treatment than the current standard of care, cannulated screws. TNT aims to improve early fixation and reduce screw backout, potentially allowing for earlier patient weight-bearing and mobilization. This innovation is particularly significant for the growing elderly population affected by pelvic fragility fractures.
SI-BONE, Inc. (Nasdaq: SIBN) ha ricevuto l'approvazione 510(k) della FDA e la Designazione di Dispositivo Innovativo per il suo Sistema di Impianto iFuse TORQ TNT™ (TNT). Questa tecnologia di nuova generazione è progettata per la fissazione delle fratture da fragilità pelvica e la fusione dell'articolazione sacroiliaca. Il sistema TNT presenta un impianto a comportamento poroso e filettato in grado di attraversare la pelvi posteriore, rispondendo alle esigenze specifiche del sacro e dell'ileo.
La FDA ha riconosciuto il potenziale di TNT di fornire un trattamento più efficace rispetto allo standard attuale delle cure, che prevede l'uso di viti cannulate. TNT mira a migliorare la fissazione precoce e ridurre il distacco delle viti, potenzialmente consentendo un caricamento e una mobilizzazione più precoci dei pazienti. Questa innovazione è particolarmente significativa per la crescente popolazione di anziani colpiti da fratture da fragilità pelvica.
SI-BONE, Inc. (Nasdaq: SIBN) ha recibido la autorización 510(k) de la FDA y la designación de Dispositivo Innovador para su Sistema de Implante iFuse TORQ TNT™ (TNT). Esta tecnología de nueva generación está diseñada para la fijación de fracturas de fragilidad pelvica y la fusión de la articulación sacroilíaca. El sistema TNT cuenta con un implante poroso y roscado capaz de abarcar la pelvis posterior, abordando las necesidades específicas del sacro y del íleon.
La FDA reconoció el potencial de TNT para proporcionar un tratamiento más efectivo que el estándar actual de atención, tornillos canulados. TNT busca mejorar la fijación temprana y reducir el retroceso de los tornillos, lo que podría permitir un apoyo y una movilización más tempranas del paciente. Esta innovación es particularmente significativa para la creciente población anciana afectada por fracturas de fragilidad pélvica.
SI-BONE, Inc. (Nasdaq: SIBN)는 iFuse TORQ TNT™ 임플란트 시스템(TNT)에 대해 FDA 510(k) 승인을 받았고, 혁신 의료기기 지정도 받았습니다. 이 차세대 기술은 골반 취약성 골절 고정 및 천장 관절 융합을 위해 설계되었습니다. TNT 시스템은 다공성 나사형 임플란트를 특징으로 하며, 후방 골반을 가로지를 수 있어 천골 및 엉덩뼈의 특정 요구를 충족합니다.
FDA는 TNT가 현재 치료 기준인 관통 나사보다 더 효과적인 치료를 제공할 수 있는 잠재력을 인식했습니다. TNT는 조기 고정 개선 및 나사 이탈 방지를 목표로 하여 잠재적으로 더 이른 환자 체중 지지와 이동을 가능하게 합니다. 이 혁신은 특히 골반 취약성 골절에 영향을 받는 노인 인구가 증가하는 것과 관련하여 중요합니다.
SI-BONE, Inc. (Nasdaq: SIBN) a reçu l'approbation 510(k) de la FDA et la désignation de Dispositif Innovant pour son Système d'Implant iFuse TORQ TNT™ (TNT). Cette technologie de nouvelle génération est conçue pour la fixation des fractures de fragilité pelvique et la fusion de l'articulation sacro-iliaque. Le système TNT présente un implant à vis poro-threadé capable de traverser l'arrière du bassin, répondant ainsi aux besoins spécifiques du sacrum et de l'iliaque.
La FDA a reconnu le potentiel de TNT à fournir un traitement plus efficace que le standard actuel des soins, les vis canulées. TNT vise à améliorer la fixation précoce et à réduire le dévissage des vis, ce qui permettrait une mise en charge et une mobilisation plus précoces des patients. Cette innovation est particulièrement significative pour la population vieillissante de personnes affectées par des fractures de fragilité pelvique.
SI-BONE, Inc. (Nasdaq: SIBN) hat die FDA 510(k) Genehmigung und die Auszeichnung als Durchbruchgerät für sein iFuse TORQ TNT™ Implantatsystem (TNT) erhalten. Diese Technologie der nächsten Generation ist für die Fixierung von Beckenfragilitätsfrakturen und die Versteifung des Sakroiliakalgelenks konzipiert. Das TNT-System verfügt über ein poröses, gewindeprofileiertes Implantat, das die hintere Beckenhälfte durchdringt und somit den spezifischen Bedürfnissen von Kreuzbein und Ileum gerecht wird.
Die FDA erkannte das Potenzial von TNT, eine wirksamere Behandlung im Vergleich zum aktuellen Standard der Versorgung mit Kanüle-Schrauben anzubieten. TNT hat zum Ziel, die frühe Fixierung zu verbessern und das Herausdrehen der Schrauben zu reduzieren, was möglicherweise eine frühere Gewichtsentlastung und Mobilisierung des Patienten ermöglicht. Diese Innovation ist besonders bedeutend für die wachsende ältere Bevölkerung, die von Beckenfragilitätsfrakturen betroffen ist.
- FDA 510(k) clearance received for iFuse TORQ TNT™ Implant System
- Breakthrough Device Designation awarded by FDA
- Potential for more effective treatment than current standard of care
- Designed to improve early fixation and reduce screw backout
- May allow for earlier patient weight-bearing and mobilization
- None.
Insights
The FDA's 510(k) clearance and Breakthrough Device Designation for SI-BONE's iFuse TORQ TNT™ Implant System marks a significant advancement in pelvic fracture treatment. This system addresses the limitations of current cannulated screws, which were not originally designed for pelvic use. The TNT's porous threaded design and ability to span the entire posterior pelvis could potentially improve fixation and reduce screw backout, critical issues in geriatric patients.
The potential for early patient weight-bearing and mobilization is particularly noteworthy. In elderly patients, prolonged immobility can lead to numerous complications. If the TNT system delivers on its promise, it could significantly reduce morbidity and healthcare costs associated with pelvic fragility fractures. However, long-term clinical data will be important to confirm these benefits and establish the system's safety profile.
This FDA clearance and Breakthrough Device Designation could be a game-changer for SI-BONE (NASDAQ: SIBN). The pelvic fragility fracture market is substantial and growing due to an aging population. If the TNT system proves superior to current methods, SI-BONE could capture a significant market share, potentially boosting revenues and profit margins.
Investors should note that this is SI-BONE's second Breakthrough Device Designation, following iFuse Bedrock Granite. This demonstrates the company's innovation capabilities and strategic focus on high-need areas in sacropelvic disorders. While the news is positive, it's important to monitor the product's commercial rollout, adoption rates among surgeons and any post-market surveillance data to fully gauge its impact on SI-BONE's financial performance.
The iFuse TORQ TNT™ system represents a paradigm shift in pelvic fracture fixation. Current cannulated screws, originally designed for hip fractures, are suboptimal for pelvic use, especially in patients with poor bone quality. The TNT's design, specifically tailored to sacropelvic anatomy, addresses a critical need in orthopedic trauma surgery.
The potential for reduced screw backout is particularly exciting. This could lead to fewer revision surgeries, a significant benefit given the high risks associated with multiple operations in elderly patients. However, surgeons will need to adapt to new techniques and instrumentation. The learning curve and long-term outcomes will be important factors in determining the system's ultimate success and adoption rate in clinical practice.
SANTA CLARA, Calif., Aug. 20, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, announces FDA 510(k) clearance of the iFuse TORQ TNT™ Implant System (TNT). The TNT implant system is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium and will serve as the next generation technology for pelvic fragility fracture fixation and sacroiliac joint fusion.
TNT includes a porous threaded implant with lengths capable of spanning the posterior pelvis, passing through the ipsilateral ilium, sacrum, and into the contralateral ilium (through and through, “TNT”). TNT was awarded Breakthrough Device Designation (BDD) by the FDA. In designating TNT as a Breakthrough Device, the FDA determined that it has the potential to provide more effective treatment of pelvic fragility fractures than the current standard of care, cannulated screws. TNT is designed to improve early fixation and reduce the rate of screw backout, which may allow for early patient weight-bearing and mobilization.
According to Charles Moon, MD, Director of Orthopedic Trauma at Cedars-Sinai, “The current smooth stainless steel cannulated screws we are using in the pelvis were designed decades ago for fixing hip fractures. When trauma surgeons began modernizing their techniques for pelvic fracture fixation, they simply started using longer screws. Numerous clinical studies have shown significant issues with this strategy, especially in the geriatric population. Screw loosening can cause pain, which can slow a patient’s progress postoperatively and may require a second surgery. As surgeons we really want to avoid second surgeries in the elderly. With TNT, there is now a system designed specifically for the sacropelvic anatomy that may reduce the rate of screw backout in this patient population. The implant is accompanied by instrumentation to match modern surgical techniques. I am very excited for the many patients who will benefit from this new technology.”
“We are pleased the FDA recognized TNT as a Breakthrough Device. The number of people bedbound from pain related to pelvic fragility fractures is large and growing,” said Laura Francis, CEO of SI-BONE. “As the leader in the sacropelvic space we’re honored to be able to help surgeons get their frail and elderly patients back to mobility sooner, by providing the first anatomy-specific system designed to meet the biomechanical challenges presented by pelvic fragility fractures. After iFuse Bedrock Granite, which also was a Breakthrough Device, this is our second device to receive the designation. This highlights our ability to develop a platform of unique solutions that target large unmet clinical needs.”
About SI-BONE, Inc.
SI-BONE (NASDAQ: SIBN) is a global leader in technology for surgical treatment of sacropelvic disorders. Since pioneering minimally invasive surgery of the SI joint in 2009, SI-BONE has supported over 3,900 surgeons in performing a total of more than 100,000 sacropelvic procedures. A unique body of clinical evidence supports the use of SI-BONE’s technologies, including two randomized controlled trials and over 135 peer reviewed publications. SI-BONE has leveraged its leadership in minimally invasive SI joint fusion to commercialize novel solutions for adjacent markets, including adult deformity, spinopelvic fixation, and pelvic trauma.
For additional information on the company or the products including risks and benefits, please visit www.si-bone.com.
iFuse TORQ, iFuse Bedrock Granite, and SI-BONE are registered trademarks, iFuse TORQ TNT is a trademark of SI-BONE, Inc. ©2024 SI-BONE, Inc. All Rights Reserved.
Investor Contact: Saqib Iqbal investors@si-bone.com
FAQ
What is the iFuse TORQ TNT™ Implant System designed for?
How does the TNT system differ from current pelvic fracture fixation methods?
What advantages does the TNT system offer for patients with pelvic fragility fractures?
When did SI-BONE (SIBN) receive FDA clearance for the iFuse TORQ TNT™ Implant System?
