WOBURN, Mass., Feb. 17, 2011 /PRNewswire/ — Intrinsic
Therapeutics, Inc., a developer of novel lumbar spine anulus
closure devices, announced today that it has enrolled the first
patient, December 17, 2010, in a Randomized Clinical Trial of its
Barricaid® device. Barricaid is designed to prevent
reherniations following lumbar discectomy, while allowing the
surgeon to retain as much of the native nucleus as possible
preserving normal disc height and biomechanics. Barricaid
accomplishes this by providing the added security of a
bone-anchored device that can be used to close larger anular
defects or in cases where anular integrity is in question.
The procedure was performed by Guido Dua, M.D., Chief of
Neurosurgery, Middelheim Hospital in Antwerp, Belgium. Robert Hes,
MD, Principal Investigator at Middelheim, stated, “What I like
about the Barricaid device is that it provides an elegant solution
to possible reherniation. Barricaid allows for a limited discectomy
while offering the potential for secure closure of the anular
defect and a reduction in both the risk of recurrent disc
herniation and disc height loss. I was very satisfied with
the simplicity and ease of the procedure. I anticipate that we will
be able to recreate the outstanding results seen in prior Barricaid
studies.”
“We are pleased to have begun our randomized study in Europe,”
said Noel Rolon, Intrinsic Vice President, Regulatory and Clinical
Affairs. “The fact that we have started enrolling patients so
quickly indicates the level of enthusiasm among our investigators.
It is clear that the positive clinical and commercial results
recently presented at the DWG meeting in Bremen and published in
the November 2010 issue of the European Spine Journal, provide a
strong foundation for this post-marketing study.”
Intrinsic is enrolling up to 800 patients in a prospective,
randomized, superiority study comparing Barricaid to traditional
limited discectomy. “We are exc
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