FDA-approved 10 kHz spinal cord stimulation system with a 16-channel rechargeable IPG, approved October 2022. Values rest on the FDA supplement record and Nevro's prescriber information; the SSED and clinical data were 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.
Nevro Senza HFX iQ SCS
Senza HFX iQ is Nevro’s current spinal cord stimulation system, approved by PMA supplement S044 on October 12, 2022. Its IPG has 16 output channels and can deliver 10 kHz therapy. This sheet is thinly sourced from the FDA record and Nevro’s prescriber information; unknown cells stay Unreported.
Identity
Field
Value and source scope
Device
Nevro Senza HFX iQ System: HFX iQ IPG (IPG3000), HFX Trial Stimulator (TSM3500), HFX iQ Remote (PTR3000) and HFX iQ Patient Application [1]
Manufacturer
Nevro Corp. [2]
Interface class
Rechargeable implantable pulse generator for spinal cord stimulation with two lead ports [2]
Origin
Commercial FDA-approved device within PMA P130022 [1]
First demonstrated
Unreported
First human implant
Unreported
Species studied
Unreported
Regulatory status
PMA P130022/S044, received March 2, 2022, decision October 12, 2022: approval of the new Senza HFX iQ IPG system [1]
Function
Delivers 10 kHz therapy that does not produce paresthesia, and can also provide paresthesia-producing stimulation at lower settings [2]
Target tissue
Spinal cord, via leads placed near the spine [2]
Geometry and architecture
Field
Value and source scope
Interface type
Two lead ports on the IPG header; compatible Nevro and competitor leads are listed in the prescriber information, not extracted here [2]
Array layout
Unreported
Electrode count
16 output channels on the IPG; contacts per lead not extracted here [2]
Titanium IPG with a hermetically sealed rechargeable battery and charging coil in the header; Bluetooth enabled; Gaea Cryptofunction software for cybersecurity features [1][2]
Data path
Bluetooth to the patient remote and application; clinician programmer software configures trial stimulators and IPGs [1][2]
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Rechargeable IPG with a charger; the trial stimulator uses 2 AAA batteries [2]
Thermal management
Unreported
Packaging and hermeticity
Hermetic titanium enclosure around a hermetically sealed battery housing [2]
MRI compatibility
MR Conditional; Nevro MRI Guidelines (P/N 10001162) give the conditions. The charger, trial stimulator and remote are not MRI safe [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
Unreported
Trials and registries
Unreported
Primary outcomes
Unreported
Key limitations
The FDA record read is a supplement for the new IPG system; pivotal 10 kHz clinical data and SSED were not read. Lead dimensions, battery life and channel mapping are Unreported here [1][2]
Engineering tradeoffs
Field
Value and source scope
Strengths
Unreported
Limitations
Unreported
Scaling constraints
Unreported
Version boundary
The sheet covers the HFX iQ IPG (IPG3000) and its trial and patient components as named in S044. Earlier Senza IPGs in P130022 and the 10 kHz pivotal trial are not described.