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.
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...
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.
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