Presentation on theme: "Martha J. Morrell MD NeuroPace, Inc."— Presentation transcript:
1 Martha J. Morrell MD NeuroPace, Inc. The NeuroPace® RNS System: Clinical Development of Responsive Cortical Stimulation as a Treatment for Medically Refractory EpilepsyMartha J. Morrell MDNeuroPace, Inc.
2 NeuroPace OverviewFounded in 1999 to design, develop, manufacture and market implantable responsive neurostimulation devices for treating epilepsy by direct brain stimulation
3 The RNS™ System Approach Detect abnormal brain electrical activity with electrodes implanted near the area of seizure onsetStimulate at the time of detection and before a seizure developsProgram detection and stimulation for individual patientTransmit device and electrocorticogram data to interactive web-based repositoryView data on-line at any time to assess clinical response
4 The RNS™ SystemCranially implanted battery powered responsive neurostimulatorConnected to 2 leads (depth and/or subdural) with 4 electrode contacts each
5 The RNS™ SystemNeurostimulator detects and stimulates abnormal brain electrical activity with implanted electrodesProgrammer sets detection and stimulation parametersProgrammer and PatientData Transmitter send ECoG data to web-based repository for review
6 Patient Data Management System Caution: Investigational Device. Limited by US Law to Investigational Use Only.Caution: investigational device. Limited by US law to investigational use only.
7 Overview: RNS System Clinical Trials in Epilepsy Feasibility Trial: completedPivotal Trial: on-goingLong-term Treatment Trial: 5 year follow-up all subjects
8 RNS™ System Feasibility Investigation Designed to assess safety of the RNS™ System and to show preliminary evidence for efficacy as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures that are refractory to two or more antiepileptic medicationsMulti-center investigation3
9 RNS™ System Feasibility Investigation: Inclusion Criteria 18 to 65 years of age with disabling simple, complex partial and/or generalized tonic clonic seizuresFailed treatment with 2 or more antiepileptic drugs4 or more simple, complex or secondarily generalized TC seizures/monthOne or two localized epileptogenic zones3
10 RNS™ System Feasibility Investigation: Trial Design ImplantRNS System123424monthsTherapy ON-nTherapy OFFBaseline: > 3 monthsPost-Implant:28 daysEvaluation: 3-28 day periodsFollow-up: 24 months post-implantAfter 2 year Feasibility trial, subjects transition toLong-term Treatment Trial for additional 5 year follow-up
11 Responder Rate During Efficacy Evaluation Period (2-4 Months Post-Implant, N= 50*) Responder Rate: patients with > 50% reduction in seizure frequency over most recent 84 days vs. baselineAll disabling seizures*24% (12/50)Complex partial seizures27% (12/44)Generalized TC seizures65% (11/17)Disabling seizures= SPM, CPS and GTC*5 subjects excluded due to inconsistencies in the data, 1 had no disabling seizures at baseline, 14 subjects randomized to sham stimulation
12 Responder Rate Over Most Recent 84 Days of Data (N = 59 Responder Rate Over Most Recent 84 Days of Data (N = 59*): All Disabling SeizuresAnalysis by seizure onset locationTotal47%Hippocampal74%Neocortical34%* 5 subjects excluded due to inconsistencies in the data, 1 had no disabling seizures at baselineData are current as of 11/2008; not completely verified.
13 Feasibility: Response over Time FS - Data updated as of 6/24/2008 – Note: the OFF patients were shifted by 111 days so the 3MO data represents 3MO after they were turned ON.Data are current as of 02/19/2009; not completely verified.
14 RNS™ System Feasibility Investigation: Summary Experience Safety milestone reachedNo unanticipated device related or surgery related serious adverse eventsPreliminary evidence for efficacyReduction in SP motor, CPS, GTC seizuresSubjects with hippocampal onset had especially good response
15 RNS™ System Pivotal Trial Randomized, double-blinded, multi-center, sham stimulation controlled240 patients enrolled at 29 sitesObjectiveDemonstrate that the RNS System is safe and effective in reducing the frequency of disabling seizures in adults with medically intractable partial onset seizures
16 RNS™ System Clinical Experience All epilepsy trials combined310 subjects enrolled246 subjects implanted> 426 patient years of post-implant experience> 367 patient years of stimulation experienceFS – updated implant years and stim years as of 6/24/2008Data current as of March 3, 2009; not completely verified.
17 RNS™ System Clinical Trials in Epilepsy Technology successfulSafety profile appears favorableNo unanticipated device related serious adverse eventsFeasibility trial shows evidence for durable efficacyFuture plansPivotal trial complete in August 2009Analysis of clinical response as a function ofDetection and stimulation programmingEpileptogenic regionEpilepsy etiology