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.（納斯達克：SIBN）是一家總部位於硅谷的醫療器械公司，致力於爲骶骨骨盆疾病提供外科手術解決方案。今天宣佈與FDA指定的突破性器械iFuse TORQ TNt植入系統（TNT）進行了首例患者手術。TNt旨在解決盆骨易碎性骨折在解剖和生物力學挑戰方面，特別是對於骨質欠佳的患者來說，TNt相較傳統導管螺釘具有重大進展。
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於2024年8月獲得510(k)清關，並獲得FDA頒發的突破性設備認定，是美國市場上首款獲准使用的3D打印橫骼橫骶螺釘。它具有針對骨盆的特定設計，以改善初始固定並減少螺釘脫出的風險。首批使用TNt進行手術的外科醫生包括愛爾利綜合醫院(Allegheny General Hospital)的Edward Westrick醫生(PA匹茲堡)，哈伯維醫療中心(Harborview Medical Center)的Reza Firoozabadi醫生(WA西雅圖)，卡德萊克區域醫療中心(Kadlec Regional Medical Center)的J.D. Black醫生(WA裏奇蘭)，以及聖路易斯帕克(MN明尼蘇達州)的衛理醫院 - HealthPartners的Brian Cunningham醫生。
