Stryker recently announced FDA 510(k) clearance for the AVAFlex Balloon System. In conjunction with other tools offered by Stryker, the device is touted as a major boon for physicians looking for a complete package in treating vertebral compression fractures (VCF).
To learn more, Surgical Products interviewed Aaron Shearer, senior brand manager with Stryker.
What can you tell us about the Stryker AVAFlex?
The AVAFlex balloon system is a minimally invasive system that allows users to achieve midline and anterior placement of the balloon. With lengths up to 30 mm, the physicians are able to get a bipedicular fill with a unipedicular approach, which is something they were only able to do with two needles before.
How does the AVAflex work with other Stryker offerings to give surgeons a more complete solution?
Previously, if a physician wanted to use a curved balloon technology, they had to use a less viscous cement or wait several minutes for the cement to cure and become thicker. Our new 510(k) clearance enables physicians to use our high-viscosity bone cement, which is called VertaPlex HV. It is ready to inject after 60 seconds of mixing in the AutoPlex. So in conjunction with innovative technology the AVAFlex balloon, these additions really empower physicians to tailor their interventional solution for the varying vertebral body fractures and patient needs they encounter.
The AVAflex uses a smaller needle. How does that impact the procedure?
With a smaller 11 gauge access the AVAFlex curved balloon gives physicians the opportunity to potentially reduce patient trauma with a smaller needle. So physicians have greater room to traverse through the pedicle and away from the medial border of the pedicle, which is where the spinal cord runs, and they can do that with a smaller needle.
It also could enable to physicians to access higher levels of thoracic spine than he or she may have never treated previously due to the smaller pedicle size.
What are the things that surgeons will immediately notice as improvements over other devices when they use the Stryker AVAFlex?
Right away they’re going to see that they can get a more medial and anterior placement of their balloon, as opposed to using a straight balloon technology. The curve really allows them to target the placement of the balloon exactly where they want to place it inside the vertebral body.
Is there anything else you'd like to add?
When Stryker acquired CareFusion’s VCF portfolio from Becton Dickinson and Co. last year, which broadened our commitment to patients and physicians for this treatment we also got access to a 13 gauge straight balloon system, which is even smaller system than what they get today with the 11 gauge. That’s more for deploying a straight balloon using a traditional bipedicular approach.
When we talk about being the most complete and the least invasive VCF portfolio on the market today, what we’re saying to physicians is regardless of who your patient is, regardless of what fracture type they have or the age of the fracture or the age of the patient, we really do offer a solution for them to fit their needs.
We want to have something on the shelf for every situation a physician can encounter.