美敦力新一代Prestige LP颈椎间盘系统获FDA预批准

2014年8月1日讯 /生物谷BIOON/ --美敦力（Medtronic）7月28日宣布，新一代Prestige LP颈椎间盘系统获FDA预批准（premarket approval，PMA），用于单节段颈椎间盘疾病（神经根型和/或脊髓型）的治疗。

Prestige LP颈椎间盘是美敦力产品组合中第三个获临床证明的人工颈椎间盘，与2007年上市的Prestige颈椎间盘具有相同的设计原理，均采用球-槽设计，允许各种运动，包括弯曲和旋转。2者的不同之处在于，Prestige需要利用骨螺钉将颈椎间盘附着至椎骨，而Prestige LP则采用了简单的滑动设计理念，通过2条轨道压配到手术过程中创造的2个预钻孔将颈椎间盘附着至椎骨。

Prestige LP由钛合金-陶瓷材料制成，已被证明比不锈钢组合物磨损更慢，且对核磁共振成像（MRI）的干扰更少。

Prestige LP的预批准，是基于一项大型前瞻性多中心临床试验，涉及545例患者，其中280例接受Prestige LP系统，265例接受标准治疗——颈椎前路椎间盘切除及融合术（ACDF）。在24个月时的数据显示，在单节段颈椎间盘疾病患者中，Prestige LP可作为ACDF的一种安全有效的替代方案。（生物谷Bioon.com）

英文原文：FDA Green Lights Medtronic’s Next-Generation Cervical Disc System

Medtronic said Monday it has received FDA premarket approval to launch the Prestige LP Cervical Disc system. The device, which is indicated for the treatment of single-level cervical disc radiculopathy and/or myelopathy, is the third clinically proven artificial disc in the company’s spinal portfolio.

The Prestige LP incorporates the same ball-and-trough design as the original Prestige Cervical Disc, which allows for a range of motions, including bending and rotating, Medtronic said. However, instead of requiring bone screws to attach the disc to the vertebrae, the LP attaches via two rails that press-fit into two predrilled holes created during surgery.

The LP also is made from a titanium-ceramic material that has been shown to wear more slowly and cause less MRI-interference than the previous stainless steel composition, the devicemaker said.

The U.S. launch of the Prestige LP is projected for mid-October, Medtronic spokesman Victor Rocha told Device Daily Bulletin. The LP version has been available outside the U.S. since 2004, with over 30,000 implants in 40 countries.

The PMA was based on a large prospective multicenter clinical trial of 545 patients, 280 of whom received the Prestige LP system and 265 who underwent anterior cervical discectomy and fusion, the standard care. Results at 24 months showed the Prestige LP to be a safe and effective alternative to ACDF in patients with single-level cervical disc disease.

To qualify for the Prestige LP system, patients must have failed at least six weeks of nonoperative treatment or shown signs of nerve root/spinal cord compression during treatment. — Kellen Owings