SpineVision Receives FDA Clearance for PediGuard surgical drill
22 February 2005
SpineVision(R) announced today that it has received from the U.S. Food
and Drug Administration (FDA) clearance to market the Company's
PediGuard(TM) instrument as an FDA Class II device. This is the first and
only FDA-cleared device for real-time detection of possible penetration
outside the vertebral pedicle.
PediGuard is a drilling instrument that constantly monitors the
electrical conductivity of the tissue at its tip throughout the drilling
process. PediGuard measures and translates the electrical conductivity into
an audio and visual feedback. Its sensitivity allows the surgeon to know
whether the tip is in contact with cortical bone, cancellous bone, soft
tissues or blood. The surgeon is immediately informed through variations of
sound cadence, sound pitch and LED flashes, when and if the electrical
conductivity at the distal part of the instrument changes--thus helping the
surgeon to better control the surgical procedure.
Accuracy of pedicle screw placement is still an issue in spine surgery.
Indeed, published rates of intraoperatively 'misplaced' pedicle screws range
from 10 to 40 percent. Of that number, 2 to 10 percent have resulted in
pathological consequences such as spinal cord damage, including paraplegia
or quadriplegia. Consequently, liability risks for spine surgeons are high.
PediGuard is the first patented, wireless, handheld instrument capable of
accurately detecting changes in tissue type, thus alerting surgeons to
potential pedicular or vertebral breaches during pedicle screw site
preparation. Real-time feedback is provided to surgeons via audio and visual
signals, giving them new additional information. The use of PediGuard
requires no change in surgical technique.
As part of the FDA clearance process, a successful multi-center study
involving PediGuard was completed. The results of this study were published
in European Spine Journal, 12(1), 2003.
"Perforation of the vertebral pedicle wall is a well-known complication
related to pedicle screw insertion. Very serious clinical consequences
--from paresthesia, partial leg paralysis to complete paraplegia -- may
result," said Randal R. Betz, M.D., Chief of Staff at Shriners Hospitals for
Children, and Medical Director of Shriners' Spinal Cord Unit. "Clinical
studies have demonstrated that the PediGuard technology allows real-time
detection of possible perforation through electrical conductivity
variation," added Dr. Betz. "In short, this device offers spine surgeons a
means to detect possible vertebral cortex perforation--prior to insertion of
pedicle screws," concluded Dr. Betz.
"The patented technology that makes PediGuard unique is very
straightforward, and the amount of time spine surgeons need in order to feel
confident in using PediGuard as a navigational tool is quite brief," said
Professor Ciaran Bolger, an internationally renowned expert in image-guided
surgery and Head of the Clinical Neuroscience Department at the Royal
College of Surgeons in Ireland. "With PediGuard, the spine surgeon remains
in control at all times during drilling and, unlike traditional methods,
there is no requirement for preoperative scans for navigational aids or
continuous screening when advancing into the pedicle. Reducing the required
amount of X-rays is both beneficial to the patient and the OR staff," said
Professor Bolger, who developed PediGuard in collaboration with
SpineVision's R&D team.
"We are extremely pleased with this FDA clearance for PediGuard," added
Gerard Vanacker, chief executive officer of SpineVision(R). "Because our
PediGuard device overcomes the great challenge of pedicle screw placement,
we strongly believe that PediGuard can become a key tool to assist surgeons.
The clinical experience exceeded our expectations in terms of product
performance and acceptance by the surgeons. This is the first of many
innovative products that we expect to bring to market in the United States."
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