Which Company Had the First FDA Indication for Painful Diabetic Neuropathy via Spinal Cord Stimulation?
Direct Answer
The evidence provided does not specify which company received the first FDA indication for painful diabetic neuropathy via spinal cord stimulation, though recent literature confirms that several SCS devices have been FDA-approved for refractory painful DPN 1.
Historical Context of SCS Regulation
- The FDA asserted authority over implantable medical devices in 1976, and in the 1980s reviewed neurostimulation devices 2
- Spinal cord and peripheral nerve stimulation devices were allowed to continue marketing in the US without formal clinical trials of efficacy, based on available publications and expert testimony 2
- Subsequent approvals of newer-generation devices were based on limited safety and usability trials 2
Recent FDA Approvals for Painful DPN
- The FDA has recently approved several spinal cord stimulation devices specifically to treat refractory painful DPN 1
- This represents a significant advancement, as SCS was previously used off-label for this indication 3
- The approval came after decades of evidence showing efficacy, including early studies from 1996 demonstrating significant pain relief 4
Clinical Evidence Supporting SCS for Painful DPN
- A 2014 multicenter randomized controlled trial showed that SCS reduced average pain scores from 73 to 31 (on a 0-100 VAS scale) at 6 months, while control group scores remained unchanged at 67 5
- At 1 year, SCS resulted in ≥50% pain relief in 63% of patients with painful diabetic polyneuropathy 6
- Early studies demonstrated that six of seven patients continued to use the stimulator as sole treatment for neuropathic pain at 14 months follow-up 4
Current Clinical Position
- SCS is recommended for extreme cases of painful DPN unresponsive to pharmacotherapy 2
- The American Academy of Neurology recognizes SCS as an established treatment (Level A evidence) for peripheral neuropathic pain, including diabetic neuropathy, that has failed conventional therapies 7
- Patients should have failed conventional medical management for at least 6 months before consideration 7
Note: While the specific company name is not identified in the provided evidence, the recent FDA approvals represent a milestone in treating this challenging condition that affects 15-25% of diabetic patients 3.