Stryker Cement Mixing System Cleared by FDA

Stryker Corporation now has FDA clearance to use the company’s own cements, implants, and the AutoPlex mixing and delivery system with its AVAflex balloon system to treat vertebral compression fractures (VCF).

The system mixes, transfers, and primes bone cement for delivery in less than 60 seconds through a single incision.

Stryker bought the technology from Becton, Dickinson and Company (BD) for an undisclosed amount in a deal that was finalized last year. The deal included BD’s CareFusion VCF portfolio, which included the AVAmax, AVAflex, AVAtex, and AVAprep products.

The company says surgeons may use either a bipedicular or unipedicular approach and that recent studies show the former produces a more stable vertebrae but the latter is less invasive and allows for quicker surgery and recovery times.

According to Stryker, the AVAflex balloon system provides “bipedicular results with a unipedicular approach” and the system’s 30mm balloon is the longest currently available on the market. The 11-guage size allows surgeons to complete the procedure through one incision with a smaller needle. One insertion, rather than two, reduces risk of complications.

CareFusion Corporation, a subsidiary of BD, first received FDA clearance for AVAflex in 2015, and Michael Verdolin of Verdolin Pain Specialists commented in a statement that “the ability to steer a balloon through unipedicular approach cannot be overstated in its simplicity and efficiency.”

The FDA clearance document to Stryker states the system is intended for the “reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements and Cortoss Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.”