Boston Scientific Neuromodulation Corporation PSC5210W ユーザーズマニュアル
2
Physician Implant Manual
Indications for Use
The Advanced Bionics PRECISION
TM
Spinal Cord Stimulator Sys-
tem (PRECISION System) is indicated as an aid in the management
of chronic intractable pain of the trunk and/or limbs, including unilat-
eral or bilateral pain associated with the following: failed back sur-
gery syndrome, intractable low back pain and leg pain.
of chronic intractable pain of the trunk and/or limbs, including unilat-
eral or bilateral pain associated with the following: failed back sur-
gery syndrome, intractable low back pain and leg pain.
Precision System Clinical Summary
Determination of the safety and effectiveness of the PRECISION Sys-
tem was based on available published clinical studies for similar
implanted spinal cord stimulation systems. The PRECISION System
is similar to the SCS systems reported in published literature in
intended use, target patient population, technology, device design, and
output characteristics. Therefore, the clinical data from the published
literature described below represents evidence supporting the safety
and effectiveness of the PRECISION System for the treatment
chronic intractable pain of the trunk and/or limbs, including unilateral
or bilateral pain associated with the following: failed back surgery
syndrome, intractable low back and leg pain.
tem was based on available published clinical studies for similar
implanted spinal cord stimulation systems. The PRECISION System
is similar to the SCS systems reported in published literature in
intended use, target patient population, technology, device design, and
output characteristics. Therefore, the clinical data from the published
literature described below represents evidence supporting the safety
and effectiveness of the PRECISION System for the treatment
chronic intractable pain of the trunk and/or limbs, including unilateral
or bilateral pain associated with the following: failed back surgery
syndrome, intractable low back and leg pain.
Efficacy Evaluation
Three (3) clinical literature studies were used to support the effective-
ness of the PRECISION System (Ohnmeiss et al. 1996, Villavincen-
cio et al. 2000, Hassenbach SJ et al. 1995). The studies included a
total of 116 patients that were implanted with an SCS system. A total
of approximately 3166 device months of experience was depicted
from the retrospective clinical evaluation. All three studies examined
the effectiveness of SCS on patients with chronic pain of the trunk
and/or limbs including unilateral or bilateral pain associated with the
following: failed back surgery syndrome or intractable low back and
leg pain. In all studies, a totally implantable spinal cord stimulator
was used in association with a percutaneous and/or surgical lead.
These studies provide the same diagnostic or therapeutic intervention
Three (3) clinical literature studies were used to support the effective-
ness of the PRECISION System (Ohnmeiss et al. 1996, Villavincen-
cio et al. 2000, Hassenbach SJ et al. 1995). The studies included a
total of 116 patients that were implanted with an SCS system. A total
of approximately 3166 device months of experience was depicted
from the retrospective clinical evaluation. All three studies examined
the effectiveness of SCS on patients with chronic pain of the trunk
and/or limbs including unilateral or bilateral pain associated with the
following: failed back surgery syndrome or intractable low back and
leg pain. In all studies, a totally implantable spinal cord stimulator
was used in association with a percutaneous and/or surgical lead.
These studies provide the same diagnostic or therapeutic intervention