NuVasive Gets IDE Approval for NeoDisc
BY JOHN MCCORMICK, JUNE 28, 2006
This morning NuVasive announced that it has received conditional approval of an Investigational Device Exemption (IDE) from the FDA to begin clinical trial enrollment of its NeoDisc cervical disc replacement device. The NeoDisc outcomes will be compared to the traditional anterior cervical discectomy and fusion procedure. NuVasive indicated that it expects to be enrolling patients 4Q:06 with a follow-up of two years.
NuVasive filed for the IDE in October of last year after only having bought the NeoDisc from Pearsalls last summer for consideration of up to $31.5 million.
