SetPoint Medical wins FDA IDE trial nod for rheumatoid arthritis implant trial
SetPoint Medical said today it won FDA investigational device exemption clearance to launch a trial of its proprietary bioelectronic device designed to treat patients with drug refractory rheumatoid arthritis.
The device is designed to be surgically placed on the vagus nerve to activate the body’s natural inflammatory reflex, the Valencia, Calif.-based company said.
“We are ready to build on the published positive data from our earlier first-in-human proof-of-concept study of bioelectronic therapy in RA, which significantly improved measures of RA disease activity in this difficult-to-treat patient population and also inhibited cytokine production. The new trial will evaluate SetPoint’s advanced generation proprietary miniaturized, rechargeable wireless implanted device. This novel device will be used to stimulate the vagus nerve in order to activate the efferent arm of the Inflammatory Reflex known as the Cholinergic Anti-inflammatory Pathway,” SetPoint chief medical officer Dr. David Chernoff said in a press release.
The multi-center study will explore the safety and efficacy of the device in adult patients with rheumatoid arthritis who have failed with multiple biological agents. The study is slated to enroll a total of 15 subjects between 22 and 75 at seven US centers, SetPoint Medical said.
“Gaining IDE approval for the clinical trial with our propriety device is an important milestone in moving our bioelectronic medicine program towards comme...
Source: Mass Device - Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Food & Drug Administration (FDA) Pain Management SetPoint Medical Source Type: news
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