Longeviti Neuro Solutions LLC has received the U.S. FDA’s nod for use of its Clearfit cranial implant with postoperative ultrasound imaging. The expanded 510(k) clearance could help in reducing radiation exposure linked to other post-neurosurgical imaging modalities.

Research has shown that current methods of post-neurosurgical imaging put patients at risk of radiation exposure, and that an estimated 29,000 future cancers could be linked to CT scan used in the U.S. each year.

“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,” said Jesse Christopher, Longeviti’s co-founder and CEO. “There is no other implant on the market that both reconstructs a patient’s skull and has FDA clearance for postoperative imaging using ultrasound.”

Patients often face complications following brain surgery, leading to multiple revision surgeries. Surgeons are looking for technologies that reduce the need for revisions and enhance neurological function.

The Clearfit technology

Comprised of polymethyl-methacrylate (PMMA), Clearfit is a neuro-reconstructive implant that surgeons use to reconstruct a patient’s cranium following brain surgery. The implants are patient-specific, implantable prosthetics intended to correct and restore bony voids and defects of the skull. Clearfit offers an array of benefits from postoperative ultrasound imaging of the brain to single-stage cranioplasties instead of two surgeries for the same procedure with better outcomes, Christopher told BioWorld.

“The Clearfit uses a patient’s CT scans and a novel 3D-printing process to ensure a precise fit and restorative contour,” he said, adding the Longeviti team works with clinicians to upload the patient’s scan and create the customized implant, which is delivered to the surgical team. Originally cleared in 2018, the implant is permanent.

Now with the new sonolucent view of the brain, imaging, stimulation and ablation can occur without patients having to undergo additional procedures, Christopher said.

“Published data shows us that approximately 1 in 1,000 adults get cancer in their head because of CT scan radiation, and 1 in 500 children,” said Chad Gordon, director of neuroplastic surgery and professor in the Department of Plastic Surgery and Neurosurgery at Johns Hopkins University. “I see this breakthrough as having two benefits: first, the introduction of safe, immediate postoperative live brain video; [and] 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.”

Clinical evidence

The FDA based its decision on a study demonstrating the safety and feasibility of elective sonolucent cranioplasty in extracranial-to-intracranial (EC-IC) bypass surgery to monitor bypass patency using ultrasound. According to the results, EC-IC bypass surgery with PMMA cranioplasty was successful in all seven patients with patent bypasses on postoperative angiogram. Direct transcranioplasty ultrasound was possible in all cases, and bypass patency was monitored. There were no procedure- or device-related complications.

Cockeysville, Md-based Longeviti sees a substantial potential market for its cranial implant. “In the next 30 years, one in 10 people in the world will have a neurological disorder, but it has been 30 years since neurotechnology has advanced,” Christopher said, adding the company’s technology will support new innovations in neurosurgery and brain therapies.

Currently, the privately held company is focused on expanding its core business and building awareness among surgeons and patients that Clearfit is an option. That includes ramping up marketing efforts in the coming year to educate patients undergoing brain surgery about additional resources that are available, Christopher said.

Looking ahead, “the underlying technology we built has broad applications, and potential to be used in critical care platforms and in delivery platforms,” he added. “Basically, we are working to develop implants that bridge form, function and power in the brain – that’s where we are headed.”

Longeviti will showcase Clearfit’s capabilities and present the results of the clinical study at the 2021 American Society of Neuroimaging virtual meeting later this week.