Kalamazoo, Mich.-based Stryker earned FDA clearance for its AVAflex Balloon System.
Here are five highlights:
1. The AVAflex Balloon System features a curved balloon for enhanced minimally invasive vertebral augmentation procedures.
2. The system is intended for use with the company's bone cements and implants as well as the AutoPlex Mixing and Delivery System.
3. Surgeons may use the AVAflex and AutoPlex systems to treat vertebral compression fractures.
4. The balloon system's 11-gauge size allows for just one insertion and smaller needle than previously used.
5. Stryker represents the exclusive provider of automatic mixing and delivery systems as well as 11-gauge curved balloons.