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Vexim receives CE Mark approval for extended SpineJack system indications

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Vexim, a medical device company based in Balma, France, has received European approval for extended indications for the SpineJack system.

The company announced in a press release its plans to the expand indications for the SpineJack system — a minimally invasive treatment for vertebral compression fractures (VCFs) — to all types of VCFs.

“We are pleased with this extension of the SpineJack’s indications to all vertebral compression fractures. It will allow us to treat a greater number of patients, and notably those who were thus far unable to benefit from our minimally-invasive approach. This strengthens our strategic positioning on the minimally-invasive back surgery market and provides us with new growth prospects for our activity,” Vincent Gardès, CEO of Vexim, stated in the press release.

The European approval was based the performance of the SpineJack system in two recent retrospective studies, according to the press release, that included 255 patients with osteoporotic, traumatic or tumor-related vertebral fractures who were followed up over a 5-year period. The system also performed will in an international clinical study that included 103 patients with traumatic vertebral fractures.