Spineart Gains IDE Approval for BAGUERA C Trial ... | 合法醫療器材資訊網

2020年8月6日—BAGUERACisanMRIcompatibledisc.Anatomicallyshapedendplatesaccommodatepatientanatomyandminimizevertebralendplate ...

Spineart received Investigational Device Exemption (IDE) approval from FDA to initiate a clinical trial of the BAGUERA® C Cervical Disc Prosthesis. The single-level trial compares BAGUERA C to another FDA approved arthroplasty device at up to 30 centers across the U.S.

BAGUERA C[1] is an MRI compatible disc. Anatomically shaped endplates accommodate patient anatomy and minimize vertebral endplate manipulation. The inner layers of the endplates feature a diamond-like-coating to minimize wear. A load sharing design and the guided mobile nucleus are intended to prevent excessive constraints on the facet joints and adjacent levels.

In 2016, two-year study results[2] indicated that patients treated with the BAGUERA C cervical disc in 1- or 2-level arthroplasty exhibited good mobility at treated and adjacent levels, disc height restoration and evidence of adjacent level preservation. ...