User Manual

Physician Lead Manual

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

for the same disease/conditions and patient population as the PRECI-

SION 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 Profile),

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 significantly

improved from baseline. In this study, 25% of the implanted patients

had greater than 50% improvement in pain rating.

In addition, 3 patients from this study had their stimulators reposi-

tioned due to pain at the original location. Three patients had reopera-

tions to adjust lead position; 1 patient required 2 reoperations, 1

patient had the device removed due to infection and later to have a

new device implanted. A diabetic patient had skin problems which