SI-BONE, Inc. Announces First-In-Patient Procedures With FDA Breakthrough Device For Pelvic Fracture Fixation, The IFuse TORQ TNT Implant System
SI-BONE, Inc. Announces First-In-Patient Procedures With FDA Breakthrough Device For Pelvic Fracture Fixation, The IFuse TORQ TNT Implant System
SI-BONE, Inc. (NASDAQ:SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, today announced first-in-patient procedures with the FDA-designated breakthrough device, iFuse TORQ TNT Implant System (TNT). Designed to address the anatomic and biomechanical challenges of pelvic fragility fractures, particularly in patients with poor bone quality, TNT offers a significant advancement over traditional cannulated screws.
SI-BONE，Inc.（纳斯达克：SIBN）是一家总部位于硅谷的医疗器械公司，致力于为骶骨骨盆疾病提供外科手术解决方案。今天宣布与FDA指定的突破性器械iFuse TORQ TNt植入系统（TNT）进行了首例患者手术。TNt旨在解决盆骨易碎性骨折在解剖和生物力学挑战方面，特别是对于骨质欠佳的患者来说，TNt相较传统导管螺钉具有重大进展。
TNT, which received 510(k) clearance in August 2024 and was awarded Breakthrough Device Designation by the FDA, is the first 3D-printed transiliac-transsacral screw cleared for market use in the U.S. It features a pelvis-specific design to improve initial fixation and reduce the risk of screw backout. Among the first surgeons to perform procedures with TNT were Edward Westrick, MD, at Allegheny General Hospital in Pittsburgh, PA, Reza Firoozabadi, MD, at Harborview Medical Center in Seattle, WA, J.D. Black, MD, at Kadlec Regional Medical Center in Richland, WA, and Brian Cunningham, MD, at Methodist Hospital – HealthPartners in St. Louis Park, MN.
TNt于2024年8月获得510(k)清关，并获得FDA颁发的突破性设备认定，是美国市场上首款获准使用的3D打印横骼横骶螺钉。它具有针对骨盆的特定设计，以改善初始固定并减少螺钉脱出的风险。首批使用TNt进行手术的外科医生包括爱尔利综合医院(Allegheny General Hospital)的Edward Westrick医生(PA匹兹堡)，哈伯维医疗中心(Harborview Medical Center)的Reza Firoozabadi医生(WA西雅图)，卡德莱克区域医疗中心(Kadlec Regional Medical Center)的J.D. Black医生(WA里奇兰)，以及圣路易斯帕克(MN明尼苏达州)的卫理医院 - HealthPartners的Brian Cunningham医生。
