{
  "schemaVersion": "2.0.0",
  "identity": {
    "slug": "microtransponder-vivistim",
    "manufacturerSlug": "microtransponder",
    "name": {
      "value": "Vivistim Paired VNS System",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.vivistim.com",
          "label": "Vivistim — official site"
        },
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "modelNumber": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "codename": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "aliases": {
      "value": [
        "Vivistim",
        "MicroTransponder Vivistim"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.vivistim.com",
          "label": "Vivistim — official site"
        },
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "generation": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "predecessorSlug": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "successorSlug": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "tagline": {
      "status": "unknown",
      "sources": [
        {
          "label": "editorial copy — not a sourced fact"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "shortDescription": {
      "status": "unknown",
      "sources": [
        {
          "label": "editorial prose — not a sourced fact"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "longDescription": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "countryOfOrigin": {
      "value": "US",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "releaseDate": {
      "value": "2021-08-27",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "announcedDate": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "discontinuedDate": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "status": {
      "value": "shipping",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.vivistim.com",
          "label": "Vivistim — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "classification": {
    "invasiveness": {
      "value": "invasive",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "modalities": {
      "value": [
        "VNS"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "primaryModality": {
      "value": "VNS",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "direction": {
      "value": "write",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "category": {
      "value": [
        "medical-implant",
        "stimulation",
        "therapeutic"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "formFactor": {
      "value": [
        "implant"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "intendedUseCases": {
      "value": [
        "treatment of moderate-to-severe upper-extremity motor deficits in chronic ischemic stroke",
        "vagus nerve stimulation paired with physical / occupational therapy"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        },
        {
          "url": "https://www.neurologylive.com/view/fda-approves-vivistim-vns-system-ischemic-stroke-motor-deficits",
          "label": "NeurologyLive — FDA approves Vivistim VNS for stroke",
          "date": "2021-08-30"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "targetUsers": {
      "value": [
        "neurosurgeon",
        "therapist",
        "patient-stroke"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        },
        {
          "url": "https://www.neurologylive.com/view/fda-approves-vivistim-vns-system-ischemic-stroke-motor-deficits",
          "label": "NeurologyLive — FDA approves Vivistim VNS for stroke",
          "date": "2021-08-30"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "electrodes": {
    "totalChannels": {
      "value": 1,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "recordingChannels": {
      "value": 0,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "referenceChannels": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "electrodeType": {
      "value": [
        "cuff"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "material": {
      "value": [
        "platinum-iridium"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "positions1020": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "channels": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "requiresGel": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "requiresSaline": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "prepTimeMinutes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "reusable": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "disposable": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "stimulation": {
    "capable": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "connectivity": {
    "protocols": {
      "value": [
        "proprietary-rf"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "bluetoothVersion": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "bluetoothProfiles": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "concurrentMode": {
      "value": "single-only",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "encryptionInTransit": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "pairingMethods": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "cloudSync": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "offlineRecording": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "power": {
    "sources": {
      "value": [
        "non-rechargeable"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "batteryLifeActiveHours": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "chargingPort": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "chargingTimeMinutes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "batteryReplaceable": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "notes": {
      "value": "Primary cell; generator replacement surgery at end-of-life.",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "physical": {
    "weightGrams": {
      "status": "unknown",
      "sources": [
        {
          "label": "v0 said 13 g; not pinned in primary sources"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "dimensions": {
      "status": "unknown",
      "sources": [
        {
          "label": "v0 listed 42 × 33 × 6 mm; not pinned in primary sources"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "materials": {
      "value": [
        "titanium"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "sizes": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "headCircumferenceCm": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "operatingTempC": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "compute": {
    "hasOnboardComputer": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "operatingSystems": {
      "value": [
        "custom-firmware"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "primaryOs": {
      "value": "custom-firmware",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "edgeMlAccelerator": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "rootAccessLevel": {
      "value": "none",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "appSandbox": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "thirdPartyAppsAllowed": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "notes": {
      "value": "Stimulation triggered by therapist via paired wireless transmitter during rehab task practice.",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        },
        {
          "url": "https://www.neurologylive.com/view/fda-approves-vivistim-vns-system-ischemic-stroke-motor-deficits",
          "label": "NeurologyLive — FDA approves Vivistim VNS for stroke",
          "date": "2021-08-30"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "software": {
    "apps": {
      "value": [
        {
          "name": "Vivistim Programmer (clinician)",
          "platforms": [
            "windows"
          ],
          "free": false
        },
        {
          "name": "Vivistim Therapist Wireless Transmitter",
          "platforms": [
            "other"
          ],
          "free": false,
          "description": "Therapist triggers paired pulses during rehab task practice."
        }
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "mobileApp": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "cloudPlatform": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "offlineMode": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "subscriptionRequired": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "rawDataAccess": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "exportFormats": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "lslSupport": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "dataOwnership": {
      "value": "manufacturer",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "privacyPolicyUrl": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "sdk": {
    "hasSdk": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "docsUrl": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "openSource": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "languages": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "webBluetooth": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "rawSampleAccess": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "bciParadigms": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "thirdPartyIntegrations": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "capabilities": {
    "attentionFocus": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "meditationCalm": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "neurofeedback": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "meditationCoaching": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "sleepTracking": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "customCapabilities": {
      "value": [
        {
          "name": "Targeted Plasticity Therapy (TPT)",
          "description": "Brief VNS pulses delivered concurrently with rehab task practice drive task-specific cortical reorganisation. VNS-REHAB pivotal trial: ~2× improvement on Fugl-Meyer Assessment vs sham at 90 days.",
          "evidenceLevel": "fda-cleared"
        }
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        },
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007B.pdf",
          "label": "FDA PMA P210007 — Summary of Safety and Effectiveness Data",
          "date": "2021-08-27"
        },
        {
          "url": "https://www.neurologylive.com/view/fda-approves-vivistim-vns-system-ischemic-stroke-motor-deficits",
          "label": "NeurologyLive — FDA approves Vivistim VNS for stroke",
          "date": "2021-08-30"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "regulatory": {
    "fdaStatus": {
      "value": "pma",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        },
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007B.pdf",
          "label": "FDA PMA P210007 — Summary of Safety and Effectiveness Data",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "ceMark": {
      "status": "unknown",
      "sources": [
        {
          "label": "v0 said true; not pinned in primary MicroTransponder sources"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "certifications": {
      "value": [
        "FDA PMA P210007",
        "FDA Breakthrough Device"
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        },
        {
          "url": "https://www.vivistim.com",
          "label": "Vivistim — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "prescriptionRequired": {
      "value": true,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "pediatricApproved": {
      "value": false,
      "status": "verified",
      "sources": [
        {
          "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf",
          "label": "FDA PMA P210007 approval letter — Vivistim Paired VNS System",
          "date": "2021-08-27"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "pricing": {
    "msrp": {
      "status": "unknown",
      "sources": [
        {
          "label": "v0 said ~$35k hardware-only; implant pricing is hospital-negotiated, not publicly listed"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "currentPrice": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "subscription": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "buyUrls": {
      "value": [
        {
          "region": "us",
          "vendor": "Vivistim",
          "url": "https://www.vivistim.com"
        }
      ],
      "status": "verified",
      "sources": [
        {
          "url": "https://www.vivistim.com",
          "label": "Vivistim — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "warranty": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    },
    "returnPolicyDays": {
      "status": "unknown",
      "updatedAt": "2026-05-04"
    }
  },
  "media": {
    "officialUrl": {
      "value": "https://www.vivistim.com",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.vivistim.com",
          "label": "Vivistim — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    },
    "productPageUrl": {
      "value": "https://www.vivistim.com",
      "status": "verified",
      "sources": [
        {
          "url": "https://www.vivistim.com",
          "label": "Vivistim — official site"
        }
      ],
      "updatedAt": "2026-05-04"
    }
  },
  "editorial": {
    "pros": [
      "FDA-approved with randomized-controlled-trial evidence (VNS-REHAB)",
      "Active, intentional pairing with rehab task practice",
      "Strong clinical rollout into US comprehensive stroke centers"
    ],
    "cons": [
      "Requires implant + ongoing therapist-led rehab sessions",
      "Voice alteration is a common side effect",
      "Limited to chronic ischemic stroke arm-motor deficits"
    ],
    "bestFor": [
      "Chronic ischemic stroke arm-motor rehabilitation"
    ],
    "notFor": [
      "Acute stroke",
      "Other rehabilitation indications (off-label)"
    ],
    "comparableDevices": [
      "livanova-sentiva",
      "electrocore-gammacore-sapphire"
    ]
  },
  "provenance": {
    "sources": [
      {
        "label": "Vivistim — official site",
        "url": "https://www.vivistim.com"
      },
      {
        "label": "FDA PMA P210007 approval letter",
        "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007A.pdf"
      },
      {
        "label": "FDA PMA P210007 — Summary of Safety and Effectiveness Data",
        "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/P210007B.pdf"
      },
      {
        "label": "NeurologyLive — FDA approves Vivistim",
        "url": "https://www.neurologylive.com/view/fda-approves-vivistim-vns-system-ischemic-stroke-motor-deficits"
      }
    ],
    "lastReviewedAt": "2026-05-06"
  }
}