SetPoint Medical Performs FDA Approved First SetPoint® System Procedure
SetPoint Medical has completed the first procedure in Texas using the FDA-approved SetPoint System®, an implantable neuroimmune modulation device for adults with moderately to severely active rheumatoid arthritis (RA).
The procedure was performed at Ascension Dell Seton Medical Center at The University of Texas by neurosurgeon Dr Daniel Peterson, marking a major step in expanding access to this innovative therapy in the Southwest.
The SetPoint System stimulates the left vagus nerve to activate anti-inflammatory pathways and is the first device-based therapy approved in the U.S. for adults with RA who have not responded adequately to advanced treatments such as biologic or targeted synthetic DMARDs.
It offers a highly targeted, leadless approach that differs from conventional therapies, aiming to improve outcomes through precise neural engagement.
The patient was referred by a board-certified rheumatologist, reflecting collaboration between surgical and rheumatology teams to bring this therapy to Texas.
SetPoint Medical’s commercial rollout continues, supported by results from the RESET-RA study published in Nature Medicine, which demonstrated clinically meaningful improvements and sustained efficacy over 12 months.
Expansion of the SetPoint System network aims to broaden access and provide a differentiated treatment option for patients living with RA.
