The ReActiv8-B is a medical device specifically designed for the treatment of chronic low back pain (CLBP) associated with muscular dysfunction, particularly involving the multifidus muscle, which plays a crucial role in stabilizing the lumbar spine. This device uses neuromuscular electrical stimulation (NMES) to restore neuromuscular control and alleviate pain.
### Key Features of ReActiv8-B:
1. Clinical Indications:
- For patients with chronic low back pain.
- Especially effective in cases where conservative treatments (e.g., physical therapy, medications, or injections) have not provided sufficient relief.
- Targeted for pain linked to multifidus muscle dysfunction.
2. Mechanism of Action:
- The device delivers electrical stimulation to the nerves that activate the multifidus muscle, encouraging contraction and strengthening.
- This helps improve spinal stability and reduces pain caused by muscular dysfunction.
3. Implantation:
- ReActiv8-B is an implantable system that requires a minimally invasive surgical procedure.
- Electrodes are positioned near the dorsal nerves controlling the multifidus muscle, and a generator is implanted subcutaneously.
4. ReActiv8-B Clinical Trial:
- The name “ReActiv8-B” is also associated with the pivotal clinical trial evaluating the device’s safety and efficacy.
- Results demonstrated significant improvements in pain, function, and quality of life in appropriately selected patients.
5. Expected Benefits:
- Reduction in chronic low back pain.
- Improvement in physical function and overall quality of life.
- Decreased long-term reliance on pain medications.
6. Limitations and Contraindications:
- Not indicated for all types of chronic low back pain, especially those of inflammatory or neuropathic origin unrelated to multifidus dysfunction.
- Contraindicated in patients with active infections, severe systemic diseases, or those unable to undergo surgical procedures.
### Clinical Relevance for a Neurosurgeon For a neurosurgeon involved in chronic pain management, the ReActiv8-B offers an innovative option within the multidisciplinary treatment approach for chronic low back pain. Proper patient selection and collaboration with pain management specialists are critical for the success of this therapy.
If you need more technical or detailed information about this device, feel free to ask!