04.14.14
European Union authorities have extended the CE mark indications for Vexim’s Spinejack system to include all types of vertebral compression fractures. The expanded approval was based on favorable results from three studies: two retrospective studies on a total of 255 patients with osteoporotic, traumatic or tumor-related vertebral fractures, who were followed over a 5-year period; and an international clinical study on 103 patients suffering from traumatic vertebral fractures.
This nod from the EU strengthens Vexim’s positioning in the treatment of unstable complex fractures that are often the result of trauma, which account for more than 42 percent of vertebral compression fractures. The approval broadens Vexim’s potential market and enables a minimally-invasive solution to be provided to patients suffering from highly-debilitating fractures by easing their pain and improving their autonomy.
“We are pleased with this extension of the Spinejack’s indications to all vertebral compression fractures,” said CEO Vincent Gardès. “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.”
Founded in 2006, Vexim is based in Balma, near Toulouse, France. The company focuses on the minimally-invasive treatment of vertebral fractures.
This nod from the EU strengthens Vexim’s positioning in the treatment of unstable complex fractures that are often the result of trauma, which account for more than 42 percent of vertebral compression fractures. The approval broadens Vexim’s potential market and enables a minimally-invasive solution to be provided to patients suffering from highly-debilitating fractures by easing their pain and improving their autonomy.
“We are pleased with this extension of the Spinejack’s indications to all vertebral compression fractures,” said CEO Vincent Gardès. “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.”
Founded in 2006, Vexim is based in Balma, near Toulouse, France. The company focuses on the minimally-invasive treatment of vertebral fractures.