Sapiens reports positive preliminary results from intra-operative deep brain stimulation study
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Sapiens Steering Brain Stimulation BV /
Sapiens reports positive preliminary results from intra-operative deep brain
stimulation study
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First proof for steering brain stimulation in patients using Sapiens' SureStim-
1 lead
Munich, Germany, and Eindhoven, the Netherlands, May 29, 2013 - Sapiens Steering
Brain Stimulation B.V. (Sapiens), an emerging medical device company developing
brain stimulation products, today announced positive preliminary results from
the intra-operative "FAME" clinical study of its SureStim-1 deep brain
stimulation lead. The preliminary data were presented today by neurosurgeon Dr.
P.R. Schuurman at the 16(th) international meeting of the World Society for
Stereotactic and Functional Neurosurgery in Tokyo.
Deep brain stimulation (DBS) is approved worldwide for the treatment of
Parkinson's disease (PD), essential tremor, dystonia, obsessive-compulsive
disorder (OCD) and more recently for the treatment of epilepsy. It is a therapy
that relies on the delivery of mild electrical pulses to specific areas in the
brain via an implanted lead that is connected to a battery-powered implantable
pulse generator. Several clinical groups are currently investigating the
application of DBS for other neurological and psychiatric disorders.
Sapiens is developing an innovative high-resolution DBS implant with the
capacity to steer electrical pulses away from areas of the brain that can
produce undesirable side-effects. The SureStim-1 system will provide the
clinician with more flexibility in adjusting and fine-tuning, which is expected
to result in uncompromised therapeutic benefits for patients. In addition,
supporting products are being developed to allow for faster implantation
procedures and more effective programming of the system in patients. Together,
these innovations allow more patients to benefit from DBS while minimizing side-
effects, and reducing time and resources for the complex procedure.
The intra-operative FAME (First-Acute-Man-Evaluation) study is the first
clinical investigation into the safety and efficacy of stimulation with Sapiens'
new high-resolution SureStim-1 lead. During a conventional DBS implantation
surgery, the Sapiens' lead was temporarily inserted for stimulation and
recording tests in 8 Parkinson's disease patients. This pilot study was recently
concluded at the Department of Neurosurgery, Academic Medical Center (AMC),
Amsterdam, The Netherlands.
In his presentation at the aforementioned conference, Dr. Schuurman, lead
investigator of the study and a member of Sapiens' Medical Advisory Board,
summarized the data, noting that within the limitations of an intra-operative
setting, the initial observations demonstrated the ability of Sapiens' lead to
steer stimulation. In addition, he explained the interesting option to
simultaneously record multiple brain signals that was demonstrated in the trial.
Hubert Martens, Co-Founder and Director of Clinical Science at Sapiens
commented: "We are very pleased with these preliminary results from the first
clinical investigation with our novel Steering DBS lead. This is a major
milestone for our company and moves us another step closer to market
introduction."
About Sapiens Steering Brain Stimulation
Sapiens Steering Brain Stimulation is an emerging medical device company with a
mission to bring the innovative concept of Steering Deep Brain Stimulation (DBS)
to more patients who can benefit from this advanced treatment of degenerative or
functional brain disorders, such as Parkinson's disease, dystonia and other
currently emerging indications.
Sapiens' ambition is to improve the therapeutic efficacy of DBS, to shorten and
simplify the clinical procedure, and to improve patient comfort. Sapiens' high-
resolution probe enables the reduction of stimulation-induced side-effects by
precisely shaping the stimulation field to the intended target area. The
SureSuite® products, SurePlan®, SurePlace® and SureTune®, provide an integrated,
image-based solution for planning and programming an optimal DBS treatment.
SureStim-1®, the Sapiens implant, is MRI-conditionally safe, and controls the
steering.
With offices in Eindhoven, the Netherlands and Munich, Germany, Sapiens was
founded in 2011. The company is a spin-out of Royal Philips, and is backed by
Wellington Partners, Edmond de Rothschild Investment Partners, Life Sciences
Partners (LSP), the Wellcome Trust and INKEF Capital. Additional support is
provided by the Michael J Fox Foundation and the European Union Framework
Program VII. Sapiens' Steering Brain Stimulation probe, implant and image-guided
programming are all based on patented technologies.
For more information please visit www.sapiensneuro.com.
Contact:
Sjaak Deckers, Co-Founder and CEO
Sapiens Steering Brain Stimulation,
High Tech Campus 41,
5656 AE Eindhoven, the Netherlands
Tel. +31 40 8002100
info(at)sapiensneuro.com
Press release PDF:
http://hugin.info/147880/R/1705336/564110.pdf
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Source: Sapiens Steering Brain Stimulation BV via Thomson Reuters ONE
[HUG#1705336]
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Datum: 29.05.2013 - 08:00 Uhr
Sprache: Deutsch
News-ID 264193
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