The FDA has cleared Viseon, Inc.’s imaging device which, according to the company, integrates minimally invasive surgical procedures with high-definition imaging technology.
Viseon Spine Imaging System Cleared by FDA
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#fda510kclearanceSecondary#minimallyinvasivesurgery#imagingequipment#viseon
The company explains the novelty of its Voyant System in a September 19, 2019 press release, “as an alternative to surgical microscopes, endoscopes and loupes, designed for use in both posterior and lateral-access minimally invasive spine procedures.”
Indications for Use
The Voyant System, according to the FDA clearance document, “is indicated to provide minimally invasive access, visualization, illumination, and magnification of the surgical area of the spine.
Device Description
The “…system is composed of the Voyant Sheath and Voyant Imager, and Accessories which includes an Image Control Box (ICB) and connecting cables. The Voyant Sheath and Voyant Imager are supplied sterile by ethylene oxide (EtO) while the ICB and connecting cables are supplied non-sterile and are reusable.”
“The Sheaths are available in multiple diameters and lengths to accommodate a variety of patient anatomies and spinal surgical procedures.”
“Likewise, the Voyant Imager is available in corresponding diameters to attach to the Voyant Sheath. The Voyant Imager connects to the Image Control Box (ICB) via an HDMI cable and live video image is displayed to a connected external HD monitor in the operating room. The ICB functions to power the Voyant Imager, process video data from the Voyant Imager to display live video image to the connected third-party HD Monitor.”
Fast Clearance
Based on the predicate, the company’s previously October 2018 cleared Voyant System, the agency took less than a month to grant clearance for the new submission. The company said purpose of the new submission was to implement design changes to the predicate to create a product line extension which includes the Voyant Sheath, Voyant Imager, and Accessories.
For the previous clearance, company President and CEO Jeffrey Valko said, “We believe the primary factor contributing to spine surgeons’ slow adoption of minimally invasive spine surgery has been inconsistent outcomes driven by the limited or lack of direct access to and visibility of the surgical anatomy. Traditional capital-intensive surgical microscopes and loupes have been in use for many years, and Viseon is offering state-of-the-art technology as a simple alternative.”
The Irvine, California-based company is privately-held and was spun out of Rebound Therapeutics in early 2017. Viseon said it raised $5 million last year in a series A financing round, which was led by HBM-MedFocus, Invus Opportunities Fund, and affiliates of Wexford Capital LP.
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Discussion
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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