Soteira has developed a broad portfolio of products to allow physicians to tailor treatment in order to obtain the best clinical outcomes for each patient.
Shield Kyphoplasty System
The Shield Kyphoplasty System is advancing procedural control during vertebral augmentation. With the unipedicular, curving cavity creation system, and a one of its kind cement directing implant, the Shield Kyphoplasty System is designed to give the physician control of cement placement. With engineered strategic flow openings, the Shield Implant provides bilateral cement placement in the anterior 2/3 of the vertebral body, while reducing the amount of cement flow to the posterior. The Shield Kyphoplasty System marks a New Level of Control in the Vertebral Body Augmentation market.
The Shield Kyphoplasty system has established an extensive body of data collected during the research and development process. The scientific materials include:
- Extensive laboratory studies confirming designed flow dynamics
- Improved height maintenance under cyclic loading compared to existing vertebral augmentation techniques
- Long term animal studies assessing the biocompatibility of the implant over time
- Pilot clinical study following patients through two years measuring pain, safety, and cement extravasation
- Randomized, multi-center, clinical trial following patients through one year measuring pain, function, safety and utilizing CT examinations demonstrating a reduction in cement extravasation.