The ClearFit implant solution will enable surgeons to reconstruct the cranium while simultaneously observing neurological anatomy and critical components.
The patient specific implant allows neurosurgeons to view neuroanatomy and critical functional components under the ClearFit, once it is implanted.
In March this year, Longeviti secured 510(k) clearance from the US Food and Drug Administration for the ClearFit implant, which is made by using biocompatible material known as polymethyl-methacrylate (PMMA).
The implant uses patient’s CT scans and novel 3D-printing process for precise fit and restorative contour.
ClearFit is a radiopaque and sonolucent implant, which provides surgeons with newfound ability to view significant neuroanatomy through the system, enabling to enhance ultrasound visibility for post-operative monitoring.
The introduction of ClearFit implant is following the recent launch of the InvisiShunt system.
Longeviti co-founder and CEO Jesse Christopher said: “For patients who require a cranioplasty as a result of trauma and/or restorative surgery, there is no one-size-fits-all treatment option.
“Building on the recent launch of the InvisiShunt and our ‘first-in-human’ experiences published in several journals such as Operative Neurosurgery, Longeviti is proud to be able to offer patients innovative, customizable solutions for various neurological procedures.”
The company is providing the new implant in three different designs, including standard ClearFit, complex ClearFit and single-stage ClearFit.
Cranioplasty procedures will be conducted to correct skull defect, as well as to provide enhanced cerebral protection, improve one’s appearance with reconstructive symmetry and reverse the under-diagnosed sunken flap or Trephined syndrome.
Longeviti is a neuro-innovation company engaged in the development of platforms for novel medical devices by using the latest in advanced technology.
In June this year, Longeviti introduced its InvisiShunt surgical implant solution in the US. InvisiShunt is a neurosurgical implant that is surgically placed in the cranium to restore its natural contour while maintaining its proper position.
The implant has been designed to alleviate cranial contour complications commonly associated with certain neurosurgical procedures.
