Longeviti Neuro Solutions, a medtech company based in Maryland, has announced that its ClearFit cranial implant has been cleared by the FDA for post-surgery ultrasound imaging. The clear implants are used for cranial reconstruction after brain surgery, and are custom-made for each patient. The company uses patient CT scans and 3D printing to produce the custom implants, and then sends the sterile constructs directly to surgeons.
Typically, ultrasound imaging of the brain is not possible in adults because of the properties of the skull. The implants allow clinicians to perform this task by being nearly transparent to ultrasound, and avoid other imaging modalities which cause radiation exposure to patients.
The implants aim to restore the natural contours of the skull while maintaining the required functionality of such a device, including the required mechanical properties and ease of visualization of the underlying tissue.
See a video about the technology below:
Medgadget had the opportunity to speak with Jesse Christopher, Co-founder and CEO of Longeviti Neuro Solutions about the technology.
Conn Hastings, Medgadget: Please give us an overview of cranial reconstruction, and the challenges posed by current solutions.
Jesse Christopher, Longeviti Neuro Solutions: Patients that have undergone brain surgery often face complications that result in multiple cranial reconstruction surgeries. Surgeons are seeking cutting-edge technologies that can help them address neurological dysfunction while simultaneously reducing the number of revision surgeries patients are likely to experience.
In a way, brain surgery is 20 years behind breast cancer. Take the 1998 women’s healthcare act. We as a society recognized the humanity of guaranteeing reconstruction after breast tumors were removed. We haven’t caught up to that philosophy in neurosurgery, and therefore many significant cranial deformities are just accepted, and to fix them today would be considered “cosmetic”. Longeviti is aiming to change that, and focuses on a holistic approach to neuro-reconstruction.
Prior to Longeviti, there was no other single solution that enabled the combination of technology within the cranium. Other solutions focus on only one of two primary neurological needs – either the functional requirements of the implant or the reconstructive requirements. Longeviti solutions address both.
Medgadget: Please describe the ClearFit system, and how it is used.
Jesse Christopher: Longeviti ClearFits are neurosurgical implants used for reconstructing patients’ craniums. ClearFits can be ordered patient-specific when a larger reconstruction is required, and they also come in smaller shapes for more immediate use and smaller reconstructions.
ClearFits offer an array of benefits, from post-operative ultrasound imaging of the brain (only implant with FDA clearance to do so) to single-stage cranioplasties (one surgery instead of two surgeries for the same procedure and better outcomes). These implants are primarily intended to correct and restore bony voids and defects of the cranium.
Medgadget: How are the implants customized for each patient?
Jesse Christopher: The ClearFit patient-specific implant uses a patient’s CT scans and a novel 3D-printing process to ensure a precise fit and restorative contour. The Longeviti team works with clinicians to upload a patient’s CT scan, which allows for the creation of a customized implant, which is then delivered to the surgical team sterilized and ready for use.
Medgadget: How do the implants help to restore the natural contours of the skull? Why are they clear?
Jesse Christopher: Patients with neurological conditions that require brain surgery often undergo multiple procedures that can change the contour of the cranium. Using ClearFit, surgeons can reconstruct the cranium while observing neurological anatomy and other functional components. With this new FDA clearance, ClearFit implants now also allow for post-operative imaging using ultrasound.
The ClearFits are both optically clear enabling one to visibly see through them, and sonolucent, allowing one to see through them with ultrasound. Ultrasound has a long history of safety and could prove promising to neurosurgeons as an additional imaging option. Most adult patients, and therefore neurosurgeons, cannot use ultrasound to view the brain because the skull doesn’t allow the images to pass through. ClearFits unlock that safe ultrasound imaging option and offer exciting opportunities for further innovation.
In short, these features help “see” in different ways, from visibly seeing a secure closure, post tumor removal, or clinical follow-up visits for imaging real-time with a cellphone. Safe, mobile, neuroimaging is something the neurosurgical community has been seeking for decades, it may be here now in 2021.
Medgadget: What drove you to develop an implant that allows ultrasound imaging?
Jesse Christopher: The ClearFit implant benefits both surgeons and patients.
ClearFit is the first reconstructive implant that offers both reconstructive properties as well as functional properties to enable imaging.
Ultrasound has been safely used directly on the brain, and with babies, for decades – it’s only the mature skull that doesn’t allow for this safe imaging. Therefore, we pursued this capability in our implants because neurosurgeons demonstrated the remarkable benefits of real-time patient communication and imaging. By using ultrasound, physicians may observe if a patient’s tumor is regrowing, or let them know their bypass is working and not the reason for their headache – all in the comfort of an office setting. ClearFit’s ultrasound properties offer a “peace of mind” that was previously unavailable – locked away by the skull. What patient wouldn’t prefer ultrasound at the bedside, as opposed to a more laborious and potentially radiating imaging modality?
For instance, surgeons at Baylor are using ultrasound to observe vascularity – and have realized they can see the blood flow through the vessels. Other surgeons from Israel are monitoring tumor beds when patients visit clinical for follow up. Today’s neurosurgical patients require imaging post-surgery, sometimes for life, and its most commonly CT scans or MRIs. Both have unique financial and logistical constraints ultrasound does not have.
Therefore, it is exciting to be exploring neuro ultrasound imaging further. Who knows, maybe someday the patient can upload their ultrasound from their home? This and other scenarios are ones that must be explored clinically and ethically.
Medgadget: What are the risks associated with repeated radiation exposure as a result of other imaging modalities?
Jesse Christopher: Research has shown that current post-neurosurgical imaging modalities carry risks due to radiation exposure and that approximately 29,000 future cancers could be related to CT scan use in the U.S. per year.
Medgadget: How did you adapt the ClearFit to allow for ultrasound imaging?
Jesse Christopher: The ClearFit and its properties have not changed since it was created, but with this new clearance from the FDA, we hope that more surgeons will leverage the implant – as there is no other implant on the market that reconstructs a patient’s skull, and has FDA clearance for post-operative imaging using ultrasound.