FDA-approved Medtronic spinal cord stimulator with closed-loop ECAP sensing, approved April 2024. Values rest on the FDA supplement record and Medtronic's announcement; the SSED was not read.
Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.
Medtronic Inceptiv closed-loop SCS
Inceptiv is Medtronic’s closed-loop rechargeable spinal cord stimulator, approved by PMA supplement S512 on April 24, 2024. This sheet is thinly sourced: the FDA supplement record names the models and features, and a Medtronic announcement adds the sensing rate and MRI statements. Unknown cells stay Unreported.
Identity
Field
Value and source scope
Device
Medtronic Pain RC SCS System: Inceptiv (model 977119), Inceptiv LT (977117) and Intellis Pro (977118) neurostimulators with Neuro Sense closed-loop feature and WR9230 wireless recharger [1]
Manufacturer
Medtronic, Inc. [1][2]
Interface class
Rechargeable spinal cord stimulator with epidural leads and closed-loop sensing of evoked compound action potentials [1][2]
Origin
Commercial FDA-approved device within PMA P840001 [1]
First demonstrated
Unreported
First human implant
Unreported
Species studied
Unreported
Regulatory status
PMA P840001/S512, received March 1, 2022, decision April 24, 2024. Medtronic reports earlier approvals in Europe and Japan [1][2]
Function
Spinal cord stimulation for chronic pain with ECAP sensing, about 50 times per second, to adjust stimulation toward the prescribed setting; Medtronic notes sensing signals may not be measurable in all cases [2]
Target tissue
Spinal cord via epidural leads [1][2]
Geometry and architecture
Field
Value and source scope
Interface type
Closed-loop feature approved for Vectris SureScan MRI 1x8 Compact leads, models 977A260, 977A275 and 977A290 only [1]
Array layout
1x8 lead per the model names [1]
Electrode count
8 contacts per Vectris 1x8 Compact lead (from the lead name) [1]
Pitch
Unreported
Electrode lengths
Unreported
Shank width and thickness
Unreported
Tip and exposed site geometry
Unreported
Contact coating
Unreported
Insulation
Unreported
Insertion method
Unreported
Anchoring and fixation
Unreported
Electrode and channel physics
Field
Value and source scope
Exposed site area
Unreported
Electrode material
Unreported
Impedance (with measurement frequency)
Unreported
Noise floor or SNR
Unreported
Recording modality
ECAP sensing by specialized circuitry and a proprietary algorithm [2]
Sampling rate
Unreported
Stimulation capability
Multiple waveform types including Medtronic Differential Target Multiplexed (DTM) programming; updated DTM user interface with Spine Anatomy View and templating in this approval [1][2]
Charge injection limit
Unreported
Reference and ground
Unreported
Tissue interface and bioresponse
Field
Value and source scope
Target tissue
Unreported
Insertion trauma and BBB disruption
Unreported
Vascular disruption risk
Unreported
Micromotion sensitivity
Unreported
Gliosis and encapsulation
Unreported
Neuron loss near sites
Unreported
Foreign-body response mitigation
Unreported
Typical failure modes
Unreported
System architecture
Field
Value and source scope
Onboard electronics
Closed-loop circuitry in the Inceptiv neurostimulator; the Intellis Pro and Inceptiv LT are named in the same approval [1]
Data path
CareGuidePro mobile application and web portal (Medtronic) [2]
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Rechargeable; new wireless recharger WR9230 [1][2]
Thermal management
Unreported
Packaging and hermeticity
Unreported
MRI compatibility
Medtronic states 1.5T and 3T full-body MRI access with no power or impedance restrictions under labeled conditions [2]
Surgical complexity
Unreported
Output connectors
Unreported
Performance envelope
Field
Value and source scope
Acute yield
Unreported
Chronic yield
Unreported
Stability over time
Unreported
Longevity
Unreported
Revision and explant experience
Unreported
Adverse events
Unreported
Notable demonstrations
Unreported
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
Unreported
Preclinical cohort
Unreported
Follow-up duration
Unreported
Indications
Chronic pain (the Medtronic announcement states treatment of chronic pain); the FDA record read does not list the indication text [2]
Trials and registries
Unreported
Primary outcomes
DTM waveform: 84% responder rate at 12 months in a multicenter open-label randomized trial (Fishman 2021, Pain Practice). This is a waveform result, not a closed-loop result [2]
Key limitations
The PMA SSED and closed-loop clinical data were not read. Statements about size, MRI and market rank are Medtronic announcement claims [2]
Engineering tradeoffs
Field
Value and source scope
Strengths
Closed-loop ECAP sensing with MRI access stated by the manufacturer [2]
Limitations
Unreported
Scaling constraints
Unreported
Version boundary
The approval covers Inceptiv, Inceptiv LT and Intellis Pro neurostimulators. Inceptiv is the closed-loop model named in the announcement. Earlier Medtronic SCS systems in P840001 are not described.