Study Results | 合法醫療器材資訊網

FlareHawkfeaturesaPEEKshellthatisinsertedinacompressedformthatcanbeeffectivelypassedthroughsmallneuralpathwaysand,oncewithinthe ...

Integrity Implants announced study results that demonstrate fusion efficacy of the FlareHawk® expandable interbody device[1], without the use of processed biologics. Further, there were no observed reports of device subsidence, and the study set provides confirmation of the cage’s ability to conform to patients’ endplate geometry.

A lumbar Interbody fusion study followed strict inclusion criteria, including the allowance of only allograft and/or autograft to facilitate fusion. Participants represented patients with noteworthy comorbidities. Among subjects with radiographs at 12 ± 3 months, nearly all achieved fusion based on Bridwell-Lenke grading. There were no observations of cage subsidence, and only one case (1.7%) of observed device migration, and the patient went on to fuse.

Surgeon participants noted that FlareHawk allowed for a transition of cases to an outpatient, and an abilit...