Vexim Initiates A New Clinical Study To Support Safety, Efficacy And Cost-Effectiveness Of Spinejack Compared To Conservative Treatment
The study will assess the safety and effectiveness of SpineJack® compared with conservative orthopedic management in 100 patients in France
Toulouse, January 12th, 2016 - VEXIM (FR0011072602 - ALVXM / PEA-PME eligible), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announced the initiation of a new clinical study in France.
The Company developped a new comparative study protocol with the Coordinators Pr Jean-Marc Vital and Pr Olivier Gille (Bordeaux, France).
This prospective, multicentric, randomized study will compare the safety, efficacy and cost-effectiveness at 1-year and 2-years follow-up of the SpineJack® device with conservative orthopedic management (bracing) on 100 patients suffering from acute traumatic vertebral compression fractures.
This study takes place at four sites in France and will reinforce the existing clinical data and good results of SpineJack® previously communicated last year in the treatment of both indications, osteoporotic and traumatic vertebral fractures, which have led in 2015 in four accepted major publications in peer scientific journals.
For further information, these two studies are registrered on the US National Institute of Health: ClinicalTrials.gov.
“Vexim confirms its clinical strategy to become the preferred treatment of reference in both osteoporotic and traumatic fields by means of the already ongoing comparative FDA study (SpineJack® vs Balloon Medtronic) and this new cost-effectiveness study in order to collect best in class healtheconomics data for strategic market“, commented Vincent Gardès, CEO of VEXIM.
Toulouse, January 12th, 2016 - VEXIM (FR0011072602 - ALVXM / PEA-PME eligible), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announced the initiation of a new clinical study in France.
The Company developped a new comparative study protocol with the Coordinators Pr Jean-Marc Vital and Pr Olivier Gille (Bordeaux, France).
This prospective, multicentric, randomized study will compare the safety, efficacy and cost-effectiveness at 1-year and 2-years follow-up of the SpineJack® device with conservative orthopedic management (bracing) on 100 patients suffering from acute traumatic vertebral compression fractures.
This study takes place at four sites in France and will reinforce the existing clinical data and good results of SpineJack® previously communicated last year in the treatment of both indications, osteoporotic and traumatic vertebral fractures, which have led in 2015 in four accepted major publications in peer scientific journals.
For further information, these two studies are registrered on the US National Institute of Health: ClinicalTrials.gov.
“Vexim confirms its clinical strategy to become the preferred treatment of reference in both osteoporotic and traumatic fields by means of the already ongoing comparative FDA study (SpineJack® vs Balloon Medtronic) and this new cost-effectiveness study in order to collect best in class healtheconomics data for strategic market“, commented Vincent Gardès, CEO of VEXIM.