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§The physician locator tool identifies pain management specialists in your area who have met certain qualifying criteria and are experienced with one or more of Boston Scientific pain management therapies. All treatment options should be discussed thoroughly with a pain management specialist.
Indications for Use: The Boston Scientific Spinal Cord Stimulator (SCS) 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, Diabetic Peripheral Neuropathy of the lower extremities, 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 Spectra WaveWriter™, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems are also indicated as an aid in the management of chronic intractable unilateral or bilateral low back and leg pain without prior back surgery.
*The Boston Scientific Spinal Cord Stimulator (SCS) Systems include the following: Precision™ System, Precision Spectra™ System, Precision Novi™ System, Precision Montage™ MRI System, Spectra WaveWriter™ System, WaveWriter Alpha™ System, WaveWriter Alpha™ Prime System.
Note: CRPS I was previously referred to as Reflex Sympathetic Dystrophy (RSD) and CRPS II was previously referred to as causalgia.
The mySCS™ Go Therapy Controller is intended to communicate with and control the compatible Boston Scientific Stimulator.
Contraindications: The Boston Scientific Spinal Cord Stimulator systems are not for patients who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant.
Warnings: With all medical procedures, there are risks associated with the procedure and the use of the device. Patients implanted with Boston Scientific Spinal Cord Stimulator systems without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Exposure to MRI may result in dislodgement of the stimulator or leads, heating of the stimulator, severe damage to the stimulator electronics and an uncomfortable or jolting sensation. As a Spinal Cord Stimulation patient, you should not have diathermy as either a treatment for a medical condition or as part of a surgical procedure. Strong electromagnetic fields, such as power generators or theft detection systems, can potentially turn the stimulator off, or cause uncomfortable jolting stimulation. The system should not be charged while sleeping. The Boston Scientific Spinal Cord Stimulator system may interfere with the operation of implanted sensing stimulators such as pacemakers or implanted cardiac defibrillators. Advise your physician that you have a Spinal Cord Stimulator before going through with other implantable device therapies so that medical decisions can be made and appropriate safety measures taken. Patients using therapy that generates paresthesia should not operate motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the stimulation on. Stimulation must be turned off first in such cases. For therapy that does not generate paresthesia (i.e. subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicles, machinery, and equipment.
Be sure to talk with your doctor so that you thoroughly understand all of the risks, precautions, and benefits associated with the use of the device and what indicates, and contraindicates, certain patients– as well as the risks and precautions for the procedure. For complete indications for use, contraindications, warnings, precautions, and side effects, call 866.360.4747 or visit Pain.com. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
Indications for use: The Intracept™ Intraosseous Nerve Ablation System is indicated for patients who have had chronic low back pain for at least six months, who have tried conservative care for at least six months, and whose MRI shows features consistent with Modic changes – indicating damage at the vertebral endplates has led to inflammation. Not every patient who meets these criteria is a candidate for the Intracept Procedure, however – in fact, there are specific characteristics indicating a patient should not be considered for the procedure.
Contraindications: Patients who are pregnant. Patients with weakened cardiac or pulmonary function, having an active implanted electronic medical device in the body (such as a pacemaker or defibrillator), being diagnosed with a systemic or local infection, or having an anatomy that could be damaged unintentionally while ablating the basivertebral nerve (based on your physicians’ clinical review). Patients who are skeletally immature – which generally means individuals under the age of 18 are not candidates.
Warnings: There are also certain risks and precautions regarding the procedure which you should be aware of before proceeding. With all medical procedures, there are risks and precautions associated with the procedure and the use of the device, talk with your doctor about what indicates, and contraindicates, certain patients for the Intracept Intraosseous Nerve Ablation System. For complete indications for use, contraindications, warnings, precautions, and side effects visit www.relievant.com/intracept/. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
Indications for Use: The Boston Scientific Radiofrequency Generators, associated Radiofrequency Lesion Probes and RF Cannula are indicated for use in procedures to create radiofrequency lesions for the treatment of pain or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution for radiofrequency lesioning of peripheral nerve tissue only. The Boston Scientific LCED and Stereotactic TCD Electrodes are indicated for use in radiofrequency (RF) heat lesioning of nervous tissue including the Central Nervous System.
Warnings: With all medical procedures, there are risks associated with the procedure and the use of the device. The Boston Scientific RF devices may cause interference with active devices such as neurostimulators, cardiac pacemakers, and defibrillators. Interference may affect the action of these active devices or may damage them. Talk with your doctor so that you thoroughly understand all of the risks, precautions, and benefits associated with the use of the Boston Scientific Radiofrequency Generators, associated Radiofrequency Lesion Probes and RF Cannula and what indicates, and contraindicates, certain patients– as well as the risks and precautions for the procedure. For appropriate guidance, consult the instructions for use for these active devices.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
NM-2200613-AC