Stryker's Balloon VCF Treatment Cleared For Use With Delivery, Mixing System
Stryker announced that the FDA has cleared its AVAflex balloon system, indicated for the minimally invasive treatment of vertebral compression fractures (VCF) through a single incision, for use with the AutoPlex mixer and delivery system. Stryker bought the technology from Becton, Dickinson and Company (BD)for an undisclosed amount in a deal that was finalized last year.
Stryker has spent over $4 billion over the past four years on over forty deals, a move that was meant to put the company on even footing with competitors who have done tax inversions, said CEO Kevin Lobo in a recent interview. Stryker completed a series of acquisitions in 2016, most of which were smaller tuck-in deals meant to augment the company’s existing businesses and product offerings.
Stryker’s largest acquisition in 2016 was a deal to purchase Sage Medical and its portfolio of disposable hospital supplies, but a handful of smaller deals were aimed principally at fleshing out Stryker’s spine business. The company acquired SafeWire, a Florida-based startup focused on minimally invasive products for spine surgeries. In another deal, Stryker picked up BD’s CareFusion VCF portfolio, which included theAVAmax, AVAflex, AVAtex, and AVAprep products.
Osteoporotic VCF is a common source of spinal discomfort and deformity in aging patients, and one approach to pain relief is injecting bone cement into the fracture. Kyphoplasty uses an inflatable balloon to create a cavity for the cement and help restore vertebral body height. Surgeons may use either a bipedicular or unipedicular approach. 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 30 mm 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, reported Orthospine News (OSN).
CareFusion, a subsidiary of BD, first received FDA clearance for AVAflex in 2015, and Michal 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.”
With this FDA approval, the system is now — for the first time — approved for use with Stryker’s cements, implants, and the AutoPlex mixing and delivery system, which mixes, transfers, and primes bone cement for delivery in less than 60 seconds.