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News

Vexim receives US FDA certification for new bone cement solution

Vexim : 01 April, 2011  (New Product)
Vexim receives US FDA certification for its flagship product Cohesion, a bone cement for injection into the vertebra for its fixation following minimally invasive spine repair with the company’s SpineJack device, or following conventional vertebroplasty.
Cohesion is a next generation high viscosity cement with characteristics ideal for patients and surgeons that combines high performance with safety, reliability and flexibility of use.

Clinical trials carried out in Europe in combination with the SpineJack device have demonstrated that Cohesion cement is effective and has a number of advantages for both the patient and the surgeon, among them :

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 three minutes from preparation to waiting) together with a significant injection time window (18 minutes at 18 degrees 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 percent 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.

Cohesion cement does not require a complex injection system and is easily adapted to all operational procedures.

'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. 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,' said Vexim Chairman Bruce de La Grange.

'Having completed our SpineJack product range and having developped innovative analytical tools that improve the Implant position before, during and after the operation as part of the OSEO-funded ILI project, we can now benefit from a product that is perfectly adapted to restorative anatomical treatments, which is a crucial step for the surgeon and for the patient,' said Vexim Chief Business Officer Vincent Lefauconnier.
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