VELOCITY: A Study to Characterize Real-World Outcomes of Spinal Cord Stimulation

The purpose of this study is to characterize the real-world outcomes of spinal cord
stimulation (SCS) therapy as an aid in the management of chronic intractable pain of the
trunk, including unilateral or bilateral pain associated with the following: failed back
surgery syndrome, intractable low back pain using the Boston Scientific (BSC) PRECISION
Spinal Cord Stimulator System with MultiWave Technology.

Key Inclusion Criteria:

- Complaint of persistent or recurrent low back pain for at least 180 days prior to
Screening

- Willing and able to comply with all protocol-required procedures and
assessments/evaluations

- Subject signed a valid, ethics committee (EC)-approved informed consent form (ICF)
provided in local language

Key Exclusion Criteria:

- High surgical risk

- Previous spinal cord stimulation trial or is already implanted with an active
implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

- A female who is pregnant, is breastfeeding, or is of childbearing potential and
planning to get pregnant during the course of the study or not using adequate
contraception.

- Participating (or intends to participate) in another drug or device clinical trial
that may influence the data that will be collected for this study

- Any diagnosis or condition that, in the clinician's best judgment, might confound
reporting of study outcomes