Longeviti Neuro Solutions today announced that it received FDA 510(k) clearance or its ClearFit implant for use in ultrasound in post-operative imaging.
ClearFit’s FDA clearance allows the device to be used during ultrasound procedures, which carries the risk of radiation exposure with other current post-neurosurgical imaging modalities.
“It is our hope that with this new clearance from the FDA, more surgeons will leverage the ClearFit implant for the benefits to them and their patients. There is no other implant on the market that both reconstructs a patient’s skull, and has FDA clearance for post-operative imaging using ultrasound,” CEO Jesse Christopher said in a news release.
The ClearFit implant is a near reconstructive implant that reconstructs a patient’s cranium. The implants are patient-specific prosthetics that correct and restore bony voids and defects of the cranium.
“Using ultrasound in post-operative imaging is something we’ve 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 tumor or follow a surgical bed in the office and not have to give the patient an MRI or CT scan every time,” Christopher Duma, a medical director for the brain tumor program at Hoag Memorial Hospital, said.
“My colleagues and I are extremely excited about this breakthrough from Longeviti. Published data shows us that approximately 1 in 1000 adults get cancer in their head because of CT scan radiation, and 1 in 500 children,” Chad Gordon, director of neuroplastic surgery at Johns Hopkins, said. “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.”