Benefits of Asleep Deep Brain Stimulation (DBS) Lead Placement With ClearPoint
Neuro Intervention System Indicated in Study of Pediatric
Primary Dystonia Patients
IRVINE, CA -- (Marketwired) -- 07/15/13 -- MRI Interventions, Inc.
(OTCQB: MRIC) today announced the presentation of data and results
indicating the benefits of its ClearPoint(R) Neuro Intervention
System as a platform for iMRI-guided deep brain stimulation (DBS)
lead placement in pediatric patients. A research team led by Dr.
Philip Starr (neurosurgeon) and Dr. Jill Ostrem (neurologist) from
the University of California, San Francisco (UCSF) presented an
abstract at the 2013 International Congress of Parkinson's Disease
and Movement Disorders in Sydney, Australia outlining data collected
from the treatment and post-operative follow up of six children with
pediatric primary dystonia who underwent iMRI-guided DBS procedures
with the ClearPoint system. Leslie Markun, MSc, lead author on the
abstract, showed that iMRI-guided DBS surgery, which allows patients
to sleep through the procedure, is a technically simple and accurate
option for a patient population that traditionally exhibits a low
tolerance for conventional awake DBS surgery. The UCSF team plans to
submit its findings for publication in a peer-reviewed journal.
Highlights of the presentation included:
-- Only a single brain penetration was used for placement of the DBS
-- The average accuracy of the lead placement was under one millimeter;
-- The average surgical time for lead placement was just over three
-- At 12 months follow up, the patients' movement scores improved an
average of 88% on the Burke-Fahn-Marsden Dystonia Rating Scale
-- Clinical outcomes were comparable to the best reported outcomes that
have been achieved using traditional methods.
"The data from this study suggest that 'asleep DBS' can be performed
extremely accurately when guided by ClearPoint," said Philip A.
Starr, MD, PhD, at UCSF, who collaborated with MRI Interventions in
developing the iMRI procedure, but holds no intellectual property
rights to it. "The clinical outcomes indicate that this is an
excellent surgical method in children, and on a MRI system providing
high resolution imaging, the procedure is straightforward to
Deep brain stimulation surgery for children has long presented a
challenge to stereotactic neurosurgeons because the procedure
traditionally has required patients to remain awake and provide
feedback to help confirm accurate placement of the DBS leads.
Children often have not been considered good candidates for DBS
surgery due to this requirement.
IMRI-guided surgery with the ClearPoint system opens up the
possibility of DBS as a treatment option for these children by
allowing patients to undergo an "asleep DBS" procedure. Using the
ClearPoint system, a surgeon can see, in real time, the inside of a
patient's brain and the location of surgical tools and devices, which
can eliminate the need for a patient's conscious feedback. The
ClearPoint system easily integrates with a hospital's existing MRI
scanner, which is ideal for real-time imaging throughout surgery
because it provides high-quality visualization of the soft tissue of
the brain and does not expose patients to ionizing radiation, unlike
other imaging methods such as computed tomography (CT) and X-ray. In
addition to DBS lead placement, the ClearPoint system can be used as
a delivery platform for neurological therapies and interventions such
as focal laser ablation, brain biopsy, and drug delivery.
The UCSF study included six patients, aged 7 to 15, with primary
dystonia. Patients were candidates for surgery if they had marked
disability and other medical therapy was ineffective. Patients
received bilateral globus pallidus or subthalamic nucleus DBS.
Funding for the study was provided by Medtronic, Inc. and MRI
Interventions, as well as a grant from the NIH.
About MRI Interventions, Inc.
Founded in 1998, MRI Interventions
(OTCQB: MRIC) is a publicly traded company creating innovative
platforms for performing the next generation of minimally-invasive
surgical procedures in the brain and heart. Utilizing a hospital's
existing MRI suite, the company's FDA-cleared and CE-marked
ClearPoint(R) system is designed to enable a range of
minimally-invasive procedures in the brain. MRI Interventions has a
co-development and co-distribution agreement with Brainlab, a leader
in software-driven medical technology, relating to the ClearPoint
system. In partnership with Siemens Healthcare, MRI Interventions is
developing the ClearTrace(R) system to enable MRI-guided catheter
ablations to treat cardiac arrhythmias, including atrial
fibrillation. Building on the imaging power of MRI, the company's
interventional platforms strive to improve patient care while
reducing procedure costs and times. MRI Interventions is also working
with Boston Scientific Corporation to incorporate its MRI-safety
technologies into Boston Scientific's implantable leads for cardiac
and neurological applications. For more information, please visit
About the ClearPoint(R) Neuro Intervention System
system is designed to allow real-time, direct visualization during
neurosurgery by utilizing the powerful imaging capabilities of MRI.
The ClearPoint system is intended to be used as an integral part of
procedures, such as biopsies and catheter and electrode insertions,
which have traditionally been performed using stereotactic methods.
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