Empirical Technologies Assists in Breakthrough Device Designation

On July 23, 2021 Dr. Randal Betz and his team, with the assistance of Empirical Technologies, received FDA’s Breakthrough Device Designation for the Vertiwedge spinal implant. The Vertiwedge implant replaces devices that disrupt the natural capabilities of the spine and that usually induce fusion to be successful.

Dr. Betz has been advancing spine surgery techniques and implantables for many years. He partnered with biomechanical engineer Dale Whipple, who has 35 years of spine implant and instrument development, and together they developed the Vertiwedge System.

Vertiwedge is indicated for use in the thoracolumbar spine for partial replacement of a diseased or damaged vertebral body. The system:

  • Removes minimal amount of the actual vertebral body, leaving more of the cortical rim that is primary to anatomical support
  • Does not require or promote fusion, for which VBRs are not indicated but are often used (almost 100% of the time); fusion can often lead to adjacent segment degeneration (ASD)

Note that this device is not yet cleared for sale in the USA or under review by FDA. It is has been accepted into the BDD system; the sponsor and representative are actively working with the FDA toward requesting 510(k) clearance in the near future.

Empirical Technologies is responsible for more than 225 510(k) clearances in the last decade.

”The Breakthrough Device Designation (BDD) program at the FDA was designed to directly benefit the patients’ needs, and this device is a perfect example of why the program exists. The FDA’s efforts to act as a proponent, not impediment, to advancing medical science are well-placed and appreciated by industry and medical professionals,” commented Meredith May, Director of Consulting at Empirical Testing Corp.

Source: Empirical Technologies

JAV

Julie A. Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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