SpineJack FDA Trial Completes Patient Enrollment

By Julie A. Vetalice

Vexim completed enrollment in its FDA clinical trial comparing SpineJack® to balloon kyphoplasty on 152 patients with osteoporotic vertebral compression fractures.

The 12-site prospective, randomized study is underway in France, Germany, Italy, Spain and Switzerland to support a planned FDA 510(k) submission by the end of 2017. Researchers seek to show non-inferiority to balloon kyphoplasty at a primary endpoint comprising a composite measure of pain reduction, maintenance or improvement in function and absence of device-related serious adverse events.

Sources: Vexim; ORTHOWORLD Inc.

 

Product Labels: Vertebroplasty/Kyphoplasty

Tags: Trial/Study