IZI Medical Products, LLC., an Owings Mills, Maryland interventional radiology device company has announced the completion of its vertebral compression fracture (VCF) treatment line with the introduction of the Osteo-Site Balloon for balloon kyphoplasty procedures.
IZI Medical Expands VCF Portfolio With Balloon Kyphoplasty Option
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Secondary#izimedical#balloonkyphoplasty#kyphoplasty
IZI entered the interventional spine arena with the purchase of Cook Medical’s vertebroplasty platform (Osteo-Site) in 2017. IZI Medical expanded its VCF offerings in 2018 through the acquisition of Benvenue Medical, Inc., which included the innovative kyphoplasty-like device and implant, Kiva, and the Blazer Curved Needle Augmentation to its product line.
CEO of IZI Medical, Greg Groenke believes that the addition of a more traditional balloon kyphoplasty option enables “our physicians to choose the most clinically appropriate solution for their patients when treating vertebral compression fractures. We have created an integrated portfolio of VCF treatment devices with the ability to switch between different treatment options with ease.”
Professor of Radiology at University Health Network Toronto and IZI Board Member, Kieran Murphy, M.D. said, “IZI has completed the VCF toolbox: Kiva for metastatic VCF’s, Blazer Curved Needle for targeted cement deployment in sclerotic bone and blastic metastases, and now Osteo-site Balloon and curved needle for osteoporotic fractures. IZI has made it simple to switch between all of them which gives me intra-operative flexibility.”
The Osteo-site Vertebral Balloon is 15mm and provided with 10G and 11G needle sizing, and uses the existing Duro-Ject Injector for bone cement application. The balloon is rated up to 400psi, which is similar to other devices on the market. The company received US FDA 510(k) clearance only 2 weeks before the launch was announced, suggesting that they expect a rapid demand for the product. A dedicated sales team will support the roll out in the US, followed by expansion into Europe.
In addition to vertebral compression fracture treatments, IZI offers interventional radiography and navigated surgery markers to enable a wide range of interventional procedures.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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