Boston Scientific Precision - Indications for Use

Precision™ Spinal Cord Stimulator System Clinician Manual
Clinician Manual
97035873-01 4 of 75
Indications for Use
The Boston Scientic Precision Spinal Cord Stimulator (SCS) System is indicated as an aid in the
management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain
associated with the following:
• failed back surgery syndrome,
• Complex Regional Pain Syndrome (CRPS) Types I and II,
• intractable low back pain and leg pain,
• Diabetic Peripheral Neuropathy of the lower extremities,
• Radicular pain syndrome,
• Radiculopathies resulting in pain secondary to failed back syndrome or herniated disc,
• Epidural brosis,
• Degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions),
• Arachnoiditis,
• Multiple back surgeries.
Note: CRPS I was previously referred to as Reex Sympathetic Dystrophy (RSD) and CRPS II was
previously referred to as causalgia.
Precision System Clinical Summary
Determination of the safety and effectiveness of the PRECISION System 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.
Efcacy Evaluation
Three (3) clinical literature studies were used to support the effectiveness of the PRECISION System
(Ohnmeiss et al. 1996, Villavicencio et al. 2000, Hassenbusch 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 for the same disease/
conditions and patient population as the PRECISION System.
The prospective study by Ohnmeiss et al. 1996, examined the long-term effectiveness of SCS in patients
with intractable leg pain. Forty patients were implanted with SCS systems and evaluated at 6 weeks,
12 months, and 24 months follow-up. Outcome measures included the VAS, pain drawings, medication use,
SIP (Sickness Impact Prole), isometric lower extremity testing, and patient questionnaires. An intent-to-treat
analysis was performed. After patients had SCS for 24 months, leg pain, pain when walking, standing pain,
pain’s effect on overall lifestyle, and the total analog scale scores were signicantly improved from baseline.
In this study, 25% of the implanted patients had greater than 50% improvement in pain rating.