Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System.
Daniel B RubinAbidemi B AjiboyeLaurie BarefootMarguerite BowkerSyndey S CashDavid ChenJohn P DonoghueEmad N EskandarGerhard FriehsCarol GrantJaimie M HendersonRobert F KirschRose MarujoMaryam MasoodStephen T MernoffJonathan P MillerJon A MukandRichard D PennJeremy M ShefnerKrishna V ShenoyJohn D SimeralJennifer A SweetBenjamin L WalterZiv M WilliamsLeigh R HochbergPublished in: Neurology (2023)
This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs defined as those requiring device explanation, resulting in death, or resulting in permanently increased disability during the one-year post implant period.
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