Vexim announced FDA certification for its flagship product Cohesion, a bone cement used for injection into the vertebra for its fixation following minimally invasive spine repair with the company’s SpineJack device, or used in conventional vertebroplasty.
“Our Cohesion cement really improves the safety and efficacy of the injection procedure thanks to its exceptional properties, and gives the practitioner full control of the fixation stage,” said Bruce de La Grange, chairman, Vexim. “Together with the SpineJack, Cohesion cement’s very high viscosity significantly reduces the risk of post-surgical leakage, even in complex fracture cases. We are pleased to have been granted FDA approval, a step which gives our product legitimate status on the market for health professionals” he added.
Clinical trials carried out in Europe in combination with the SpineJack device have demonstrated that the Cohesion cement is effective and has a number of advantages for both the patient and the surgeon:
– Optimisation of injection safety thanks to the product’s cohesive properties (made possible by the cement’s viscosity at the time of injection). This considerably reduces the risk of leakage in comparison to standard cements. The product also features mixing and working properties that entail a reduction in the waiting time before it reaches the right viscosity level (around 3 minutes from preparation to waiting) together with a significant injection time window (18 minutes at 18°C) which gives the practitioner enough of a safety margin to inject the cement without having to feel hurried, and enhances the safety of the procedure.
– Considerable opacity thanks to its 45% Zircon oxide content which makes it easier to visualise and inject the cement in low quantities and to optimise the cement interdigitation whilst also enhancing the overall operational security of the procedure.
-This cement does not require a complex injection system and is easily adapted to all operational procedures.