FDA clears Vexim's COHESION bone cement to treat vertebral compression fractures

Vexim, the specialist in medical instruments designed for the minimally invasive, anatomical treatment of vertebral compression fractures, today announced that it had been awarded FDA clearance for its new product COHESION™, a bone cement for injection into the vertebra following minimally invasive spinal fracture anatomical restoration with the company's SpineJack® device or used in performing a conventional vertebroplasty.

Clinical trials carried out in Europe have demonstrated that in combination with the SpineJack®, COHESION™ cement is safe and effective and has a number of advantages for both the patient and the surgeon, including:

• Safer injection, thanks to the product's cohesive properties and viscosity at the time of injection. This considerably reduces the risk of leakage, in comparison with standard PMMA cements.
• The product also features mixing and working properties that reduce the time needed to reach the right viscosity level (around 3 minutes from preparation to injection).
• A wide injection time window (18 minutes at 18°C) gives the practitioner enough of a safety margin to inject the cement without having to hurry and thus enhances the procedure's safety.
• High opacity, thanks to a 45% zirconium oxide content - making it easier to visualize the cement (even when injected in small amounts) and optimize interdigitation throughout the vertebra, while also enhancing the procedure's overall safety.

Moreover, COHESION™ cement does not require a complex injection system and can be easily adapted for use in all types of operating theaters.

"Thanks to its exceptional properties, our COHESION™ cement really improves the safety and efficacy of the injection procedure and gives the practitioner full control of the stabilization step. When combined with the SpineJack®, the COHESION™ cement's very high viscosity translates into excellent outcomes - even in complex fractures. We are delighted to have been granted FDA clearance - a milestone which legitimatizes our product in the US surgical market", commented Vexim chairman and CEO, Bruce de la Grange.

"After having completed our product range around the SpineJack® by developing innovative analytical tools that improve the SpineJack procedure and gives a reproducible way of analyzing anatomical restoration (as part of the ILI project part-funded by Oséo, the French state innovation agency), we now can offer a product that is perfectly suited to stabilizing vertebral fractures after restoration is achieved - a crucial step for both the surgeon and the patient" added Vincent Lefauconnier, Vexim's Chief Commercial Officer.