boston scientific dorsal column stimulator

#BOSTON SCIENTIFIC DORSAL COLUMN STIMULATOR MANUAL#
#BOSTON SCIENTIFIC DORSAL COLUMN STIMULATOR FULL#
#BOSTON SCIENTIFIC DORSAL COLUMN STIMULATOR TRIAL#

Patients implanted with Boston Scientific Deep Brain Stimulation Systems without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). The Boston Scientific Vercise Deep Brain Stimulation System is indicated for use in:Ĭontraindications, warnings, precautions, side effects: The Deep Brain Stimulation Systems or any of its components, is contraindicated for: Diathermy as either a treatment for a medical condition or as part of a surgical procedure, Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS) as the safety of these therapies in patients implanted with the Vercise™ DBS System has not been established, patients who are unable to operate the system, patients who are poor surgical candidates or who experience unsuccessful test stimulation. The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) is indicated for the suppression of tremor in the upper extremity. Bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy in reducing some of the symptoms of advanced levodopa responsive Parkinson’s disease (PD) that are not adequately controlled with medication. Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa responsive Parkinson’s disease (PD) that are not adequately controlled with medication.

The Boston Scientific Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimulation Systems are indicated for use in:

#BOSTON SCIENTIFIC DORSAL COLUMN STIMULATOR MANUAL#

The Vercise Genus™ DBS System, Vercise Gevia™ DBS System, and Vercise™ DBS Lead-only system (before Stimulator is implanted) provide safe access to full-body MRI scans when used with specific components and the patient is exposed to the MRI environment under specific conditions defined in the supplemental manual ImageReady™ MRI Guidelines for Boston Scientific DBS Systems. Federal law restricts this device to sale by or on the order of a physician. Refer to the Instructions for Use provided with the SCS System or for potential adverse effects, warnings, and precautions prior to using this product.Ĭaution: U.S.

#BOSTON SCIENTIFIC DORSAL COLUMN STIMULATOR TRIAL#

The SCS Systems are contraindicated for patients who: are unable to operate the SCS System, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant. Contraindications, warnings, precautions, side effects. Associated conditions and etiologies may be: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, multiple back surgeries. The Boston Scientific Spinal Cord Stimulator Systems are 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.

Gilbert et al., Computational modeling predicts dorsal columns are involved in fast-acting sub-perception spinal cord stimulation (SCS). FAST MOA based on computational modeling from Dr.

#BOSTON SCIENTIFIC DORSAL COLUMN STIMULATOR FULL#

Full stimulation parameter ranges and options for both paresthesia-based and subperception therapy are available for clinician’s use throughout the patient’s experience and treatment with SCS.ġ. Subperception stimulation has been demonstrated to be safe and effective in patients who have been treated successfully with conventional, paresthesia-inducing stimulation for at least six months. *The WaveWriter Alpha™ SCS System provides safe access to full-body MRI scans when used with specific components and the patient is exposed to the MRI environment under the defined conditions in the ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator System.

Boston scientific dorsal column stimulator