Shots:
- The US FDA has approved the SetPoint System to treat adults with mod. to sev. rheumatoid arthritis (RA) who are inadequately managed by or intolerant to existing advanced therapies, incl. biologics & targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs)
- Approval was based on RESET-RA study evaluating SetPoint System vs sham device in 242 pts, which showed favorable safety & efficacy in above mentioned pts
- SetPoint System is an implantable neurostimulation device that delivers once-daily electrical stimulation to the vagus nerve to activate the body’s natural anti-inflammatory & immune-restorative pathways
Ref: Businesswire | Image: SetPoint Medical| Press Release
Related News:- Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment
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