一个新的脊椎盘装置比美国试验期间的聚变手术更能缓解疼痛和发挥功能,48个月没有安全问题。
A new spinal disc device showed better pain relief and function than fusion surgery in a U.S. trial, with no safety issues through 48 months.
在2025年11月7日的DOCS健康脊柱关节塑造峰会上,Todd H. Lanman博士分享了美国Synergy Disc® 1-Level IDE试验的初步结果,显示在24个月后,该设备导致与传统融合手术相比,部和手臂疼痛和残疾得分明显改善.
At the DOCS Health Spine Arthroplasty Summit on November 7, 2025, Dr. Todd H. Lanman shared initial results from the U.S. Synergy Disc® 1-Level IDE trial, showing at 24 months that the device led to significantly better outcomes in neck and arm pain, and disability scores compared to traditional fusion surgery.
该试验涉及20个中心的175名病人,发现 " 协同磁盘 " 在48个月的时间里保持了运动和脊椎调整的范围,没有安全问题。
The trial, involving 175 patients across 20 centers, found the Synergy Disc® maintained range of motion and spinal alignment with no safety issues through 48 months.
该装置是为以前有核聚变的病人设计的,使用与磁共振成像相容的材料,并可在2026年初之前支持林业发展局的市场前批准。
The device, designed for patients with prior fusions, uses MRI-compatible materials and may support FDA pre-market approval by early 2026.