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.