Personalized Implants for Personalized Pain
We are all different. Our spines, like our fingerprints, are unique to each of us.
When we have spine health issues, like disc degeneration or spinal stenosis, our spines can come out of alignment and cause back, leg, and nerve pain.
The solution to this malalignment of our spine is to restore height with a spinal implant and re-align our spines. For decades, surgeons have only had access to mass-produced spinal implants with generic sizing and surfaces.
While these implants may help, they fall short of reaching your alignment goals because they simply don’t match your anatomy, and the alignment you need may not occur. This often results in ongoing pain and future surgeries that may be needed.
This is the problem that the aprevo® personalized spine procedure was designed to overcome. By creating a one-of-a-kind implant using the latest imaging and 3d generation techniques, we are able to create an implant that helps you and your surgeon get closer to those alignment goals and potentially have better outcomes than any mass-produced implant could hope to achieve.
The aprevo® Difference
Spine surgery techniques rely on images (CT scans and X-rays) to see various views of your spine. Surgeons would typically perform complex manual measurements of these films to determine the correction angles needed to restore your spine to an aligned state. The surgeon would then order mass-produced implants that attempt to help them reach those alignment goals. The aprevo® personalized spine procedure delivers breakthrough technology to both the planning and implant solutions, setting a new standard for spine treatment.
The aprevo® Personalized Spine System is the only spine implant that is personalized for you.
Watch our Patient Video to learn how aprevo® can help you Get Your Power Back.
The aprevo® Personalized Spine System Process
Spine surgeons create their approach based on your films and determine implant sizes and angles needed through manual 2D measurements and calculations.
During surgery, your surgeon will “flatten” your endplates with surgical tools to make the implant fit better and achieve fusion. The surgeon may, after flattening your endplates, decide to use a smaller or larger size implant to accommodate a better fit. The resultant mismatch between stock devices and vertebral endplates often creates significant gaps.1
Your aprevo® implants fit your unique anatomy without shaving and “flattening” your endplates to accommodate a generic shape. Your anatomy and its unique features are maintained with much less preparation than conventional implantation.The FDA Breakthrough Device Designation
Unique. Innovative. Breakthrough.
aprevo® is the first spine implant to receive FDA Breakthrough Device designation as well as the Transformative New Technology designation from CMS.
Furthermore, aprevo® is the first spine technology breakthrough device to obtain marketing authorization from FDA.3
Scan
A CT scan is needed for the creation of personalized aprevo® surgical plans and implants.
Design
A 3D model of the spinal malalignment and a proposed correction is presented in the myaprevo™ app. Carlsmed’s secure user interface allows you to easily review, modify, and approve the proposed 3D surgical plan and devices.
Deliver
Once the plan is approved by the surgeon, aprevo@ implants are 3D printed, sterilized, and delivered to the hospital before surgery.
It all begins with YOU.
Talk to your doctor about the aprevo® patient-specific spinal implants, or find a doctor with our surgeon locator.
References:
- Feng Z, Liu Y, Yang G, Battié MC, Wang Y. Lumbar vertebral endplate defects on magnetic resonance images. Spine. 2018;43(13):919-927.
- Smith JS, Elias E, Line B, et al. 51. how good are surgeons at achieving their goal sagittal alignment following adult deformity surgery? The Spine Journal. 2022;22(9).
- Breakthrough devices program. U.S. Food and Drug Administration. November, 2023
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