Spark Biomedical, a Texas-based medical device company, announced this week that the FDA has granted 510(k) clearance for its Sparrow Therapy System, a wearable neurostimulation device for the treatment of opioid withdrawal. With FDA clearance obtained, the Sparrow system is now available to U.S. physicians to treat patients for opioid withdrawal.
To complete Level 1 clinical evidence, Spark conducted a 12-month trial for Sparrow in which 26 participants enrolled in a randomized, controlled trial to determine the effectiveness of the system. Effectiveness was measured using the 11-point Clinical Opioid Withdrawal Scale. A reduction in symptoms of more than 15% within 60 minutes of therapy was considered a meaningful reduction on the scale. Participants received the neurostimulation therapy for five days, and on the second through fifth days, all participants showed a sustained, meaningful reduction in symptoms.
The study is scheduled to be completed early this year, with full results to be published at a later date.
In a news release announcing that the Sparrow system has received FDA clearance, Spark co-founder and chief technology officer Alejandro Covalin, PhD, said the clearance “brings us a step closer to a world of non-invasive devices in which medical problems can be solved with targeted neuromodulation as opposed to systemic medicine.”