Longeviti Neuro Solutions has announced the 510(k) clearance by the US Food and Drug Administration (FDA) of its ClearFit cranial implant, which it claims allows for ultrasound imaging post operation.
According to a company press release, the ClearFit implant is a neuro reconstructive implant that surgeons use to reconstruct a patient’s cranium. Longeviti further claims the implants are patient-specific, implantable prosthetics that are intended to correct and restore bony voids and defects of the cranium.
According to Longeviti, 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 computed tomography (CT) scan use in the USA per year.
Christopher Duma (Hoag Memorial Hospital, New Port Beach, USA) commented, “Using ultrasound in post-operative imaging is something we have thought about, but never really had the technology to do previously. With ClearFit we can do it, and we can do it in the doctor’s office. It is really a great concept. The object here would be to be able to follow a tumour or follow a surgical bed in the office and not have to give the patient an MRI or CT scan every time.”
“My colleagues and I are extremely excited about this breakthrough from Longeviti. Published data shows us that approximately one in on thousand adults get cancer in their head because of CT scan radiation, and one in 500 children,” said Chad Gordon (Johns Hopkins, Baltimore, USA). “I see this breakthrough as having two benefits: First, the introduction of safe immediate postoperative live brain video. Second, that we can now image much more frequently, when needed, whether there are areas of concern or to put our patients’ minds at ease.”