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New FDA 510(k) Clearance Highlights Ultrasound Capabilities of Longeviti ClearFit Implant

·3-min read

Cranial Implant Allows for Ultrasound Imaging Post Operation

Longeviti Neuro Solutions today announced a new 510(k) clearance by the U.S Food and Drug Administration (FDA) for the ClearFit® implant that acknowledges the use of ultrasound in post-operative imaging.

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. 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.

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.1

"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, MD, Medical Director, Brain Tumor Program, Hoag Memorial Hospital.

"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, MD, 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.

The capabilities of the ClearFit implant will be showcased and discussed at the 2021 Annual Meeting of the American Society of Neuroimaging. On Jan. 28 at 2:30 pm EST, Jan-Karl Burkhardt, MD, will present the results of a clinical study, which sought to analyze the safety and feasibility of the ClearFit implant using ultrasound imaging after a neurovascular procedure. Christopher Duma, MD, will be speaking on ClearFit implants Register to attend the upcoming event.

Watch a video illustrating how the Longeviti ClearFit Implant works. https://youtu.be/AsTn5EkS-ss

About Longeviti

Longeviti is advancing neurosurgery through the development of low-profile intracranial implants that address the functional and reconstructive needs of patients with neurological conditions. Since 2018, the company has brought several FDA-cleared implants to market. Longeviti’s focus is to develop innovative solutions for complex brain surgery that return patients to anatomical normalcy. For more information, visit www.longeviti.com and follow Longeviti on Twitter or LinkedIn.

1Biological Effects of Ionizing radiation VII Phase II. National Academics Press 2006; Smith-Bindman R. Arch Int Med 2009

View source version on businesswire.com: https://www.businesswire.com/news/home/20210126005394/en/

Contacts

Shay Smith
Health+Commerce
shay@healthandcommerce.com