FDA Clears Longeviti’s Reconstructive Cranial Implant

The U.S. Food and Drug Administration (FDA) recently cleared a brain implant from Longeviti Neuro Solutions that enables clinicians to capture images of the brain after surgery.

The Longeviti ClearFit implant is a neuro reconstructive implant that surgeons use to reconstruct a patient’s cranium. The implants are patient-specific, implantable prosthetics that are intended to correct and restore bony voids and defects of the cranium.  Longeviti’s focus is to develop innovative solutions for complex brain surgery. The company is advancing neurosurgery through the development of low-profile intracranial devices (LIDs) that address the functional and reconstructive needs of patients with neurological conditions.  

“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,” said Christopher Duma, M.D., medical director, Brain Tumor Program, Hoag Memorial Hospital.
 
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 United States per year.1
 
“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,” said Chad Gordon, M.D., director of Neuroplastic Surgery and professor in the Department of Plastic Surgery and Neurosurgery at Johns Hopkins. “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.”
 
“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,” said Jesse Christopher, co-founder and CEO, Longeviti.
 
Watch a video illustrating how the Longeviti ClearFit Implant works here. 
 
Reference
¹ Biological Effects of Ionizing radiation VII Phase II. National Academics Press 2006; Smith-Bindman R. Arch Int Med 2009