NeuraMedica, Inc., a medical device maker based in Oregon City, has received a key clearance from the U.S. Food and Drug Administration.
“It’s a huge deal,” said Rachel Dreilinger, NeuraMedica co-founder and CEO. “FDA clearance is major and something we’ve been working toward for years and years and years, and a lot of the funding we’ve received has gone toward this.”
The 510(k) clearance means NeuraMedica can now market and sell its DuraFuse Dural Clip. The device allows neurosurgeons and orthopedic spine surgeons to close incidental and planned spinal durotomy, or tear in the dura mater covering the spinal cord. Dural tears occur frequently during spinal surgery.
NeuraMedica’s clip allows the tears to be closed in a fraction of the time it would take to suture the dura. Time is of the essence, as dura matter must be repaired as quickly as possible to prevent cerebrospinal fluid leakage.
NeuraMedica has raised $3.6 million from investors and in grants from OHSU, the NIH and other entities.
Dreilinger said she will first focus on selling the clips to local hospitals before doing a fully commercial launch later this year. The first surgeon to use it will be Dr. Neil Roundy, a neurosurgeon at Oregon Neurosurgery in Springfield and co-founder and chief medical officer of NeuraMedica, Dreilinger said.
