A Medical Device Daily
Spine Wave (Shelton, Connecticut) reported that it has begun patient enrollment in a feasibility investigational device exemption clinical trial studying the company's NuCore Injectable Nucleus. The company said the NuCore Injectable Nucleus is the first injectable spinal nucleus device to be implanted into patients within an FDA-approved study.
In the study, the NuCore Injectable Nucleus will be implanted following a standard microdiscectomy procedure in order to fill the void created when herniated nuclear material is surgically removed from the disc. The NuCore material is injected in liquid form, then rapidly cures to a gel that has physical properties similar to those of the natural nucleus. The goal of the procedure is to supplement the remaining natural nucleus and in so doing, restore the normal biomechanics of the disc.
“Unlike many other spinal implants, the injectable nature of the NuCore material allows it to be used in a minimally invasive fashion, therefore minimizing damage to the surrounding tissues,“ said prinicipal investigator Scott Kitchel, MD, assistant clinical professor of orthopedic surgery at Oregon Health Sciences University (Portland). “The NuCore Injectable Nucleus has the potential to help thousands of patients who suffer from back and associated leg pain.“
The NuCore Injectable Nucleus was developed in conjunction with Spine Wave's technology partner, Protein Polymer Technologies (PPTI; San Diego). PPTI will manufacture the NuCore material for Spine Wave's clinical trials.
Spine Wave has now enrolled patients in microdiscectomy studies of NuCore in Switzerland, Australia, Germany and the U.S., and expects to expand enrollment of these and other studies in the first half of 2006. The company said it also expects to initiate enrollment in European clinical studies to assess the potential of the NuCore to help treat patients suffering from degenerative disc disease.