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Post-market review of spinal cord stimulation (SCS) devices
Find out more about the post market review we are undertaking on spinal cord stimulators (SCS).
The TGA continues to progress the post-market review into SCS devices. This page will be updated as regulatory decisions are finalised.
The TGA does not publish stand alone reports on the outcomes of post-market reviews. All information on the outcomes of spinal cord stimulator post-market reviews are published below.
What are Spinal cord stimulators?
SCS are implantable devices that send low levels of electrical stimulation directly to the spinal cord with the aim of relieving pain. These devices are used in complex chronic pain scenarios and are generally used as a last line of treatment. Patients may undergo a trial stimulation period prior to placement of a long-term implantable device to ensure treatment with an SCS is suitable for their condition.
Background of the review
We have received a range of signals related to SCS devices, including increasing reports concerning the safety and performance of these devices.
In 2022, in response to emerging signals, we initiated a post-market review into all SCS devices included in the Australian Register of Therapeutic Goods (ARTG). The review was to assess the safety and performance of the devices, including reviewing real-world evidence available for these devices.
As part of the review, we required all sponsors of SCS devices included in the ARTG to provide us information about their product, including:
- Number of devices supplied within Australia
- Indications and contraindications for use
- Advertising material
- Labelling information including the Instructions for Use (IFU), Patient Information Leaflets (PILs) and Patient implant Cards (PICs)
- All domestic and international incidents, adverse events, complaints, and any investigations undertaken, and corrective actions made as a result of these investigations
- Clinical data supporting the intended use of their device, and
- Evidence supporting the long-term safety of their device.
Post-market review: overview
As part of ARTG inclusion sponsors and manufacturers have a range of post-market obligations. This includes maintaining evidence that devices continue to be safe and perform as intended throughout their lifecycle and provide this evidence to us when requested.
Throughout the review, the TGA has considered a range of information to ensure all regulatory decisions are evidence-based, including seeking expert advice on risks and benefits relating to these devices, including both published literature and data held by sponsors and manufacturers for their device.
Expert opinion was sought from the Advisory Committee for Medical Devices (ACMD) about patient selection, long-term safety and performance studies, patient information materials (including instructions for use), and the importance of treating the underlying cause of the pain. The ACMD advised:
- Several million people are attempting rehabilitation for their chronic back pain daily and only a small percentage proceed to surgery or SCS.
- Clinicians should carefully consider patient selection for SCS devices to ensure effective rehabilitation.
- Back pain rehabilitation guidelines should be amended for clarity and should follow a valid cause-based paradigm of care and be applied in conjunction with the SCS surgery.
The adequacy of device manufacturer documentation and IFU in relation to these devices have been key considerations of the review.
Following review of evidence provided by sponsors and manufacturers, we have decided to take regulatory action in relation to a number of SCS sold in Australia.
Post-market review: outcomes and actions
Throughout the review, we have taken a range of actions, such as requiring amendments to labelling and IFUs, if deficiencies were identified. Additional information now includes:
- Improving information regarding the risks associated with the SCS devices including further clarification on indications and contraindications for use, and
- Providing further information about the expected lifespan of the devices.
As the review is near completion, we have also made final regulatory decisions on numerous entries, including:
- Cancellation (removal) from the ARTG; or
- Imposed Conditions of Inclusion (COI) on SCS devices in the ARTG.
Where a SCS device has been cancelled from the ARTG, they are not being recalled from the market and do not need to be removed from patients if already implanted. The cancellation means no new patients will receive these implants.
To ensure the highest level of patient safety possible, the TGA has imposed 'conditions' on a number of SCS that remain available in Australia. This means that for a sponsor to continue supplying a SCS device in Australia, they must meet a range of requirements.
A condition can impose further requirements as seen appropriate to support the safe ongoing use. The conditions enable us to closely monitor the devices overtime and take action promptly if any issues are identified.
The conditions imposed are different for each sponsor and may require:
- The sponsor to provide additional information, such as post-market clinical follow up studies to the TGA annually.
- Restrictions or alteration of the intended purpose of the device to specify use in particular patient populations that is supported by the evidence which allows more appropriate use of the device and patient selection.
Where changes are made to the intended purpose, we will work closely with the sponsor to ensure this information is clearly reflected in relevant labelling.
The conditions imposed on each entry can be found by searching the ARTG public summary with the ARTG number.
Information for consumers and healthcare professionals
Health care professionals
The Australian Commission on Safety and Quality in Health Care (ACSQHC) has published a number of documents relating to clinical practice, diagnosis, investigation and management of lower back pain. Appropriate patient selection for use of spinal cord stimulation and device suitability for individual conditions remain of utmost importance in the consideration of use of these devices.
As part of the review, we have provided feedback to the sponsors and manufacturers of these devices relating to information that is provided to healthcare professionals about the safe use of these devices and more effective patient selection.
Healthcare professionals should ensure they provide sufficient information about these devices to enable informed educated consent by their patients. The ACSQHC has published a range of resources related to informed consent and shared decision-making.
For healthcare professionals/hospitals who want to use a device that has been cancelled from the ARTG:
- For stock already on hand (on shelves), the device can be used for the purpose it was supplied when the ARTG entry was still valid, if considered appropriate by the healthcare professional. If the device is being used for private patients and being reimbursed by private health insurers, you will need to confirm whether the private health insurer will reimburse a device no longer included in the ARTG.
- You can import or supply cancelled devices or accessories by applying under the Special Access Scheme (SAS) or Authorized Prescriber (AP) scheme if you feel your patient requires a device that is no longer included on the ARTG. To supply an unapproved device under the SAS or AP scheme there must be no suitable devices in the ARTG for the relevant condition(s) and patient(s).
If you have questions or concerns regarding ongoing maintenance of these devices, please contact the sponsor of the device directly. This includes queries on the possible need for eventual replacement of parts for already implanted devices. As mentioned above, reimbursement of any potential replacement parts for a cancelled device should also be confirmed with private health insurers.
Healthcare professionals should continue to report all adverse events associated with a SCS implant to the TGA when they occur. Healthcare professionals should further ensure their patients are aware of how to report device concerns to the sponsor and the TGA.
Consumers
Although some devices have been cancelled from the ARTG, they are not being recalled from the market and do not need to be removed if already implanted.
Following our review, advice for all implants is as follows:
- Even if your implanted device is being cancelled from the ARTG, medical experts do not recommend removing them.
- If you have a spinal cord stimulator, you should monitor your own health, get regular clinical check-ups and follow your health care professional’s advice as per the usual process for these kinds of procedures.
- If you have any concerns, contact your healthcare professional to determine if a change in your treatment is advisable.
- If you have any concerns about the safety or performance of your device, you may also report this to the TGA.
Consumers should consult their treating healthcare professional if they have any questions regarding the safety or performance of their SCS device.
When SCS is discussed as an option for care, ensure that you receive information on all your care options, including any education on both the risks and benefits of this treatment for you as an individual. You may wish to access the TGA’s “Five questions to ask your health professional before you get a medical implant.”
Reporting problems
Patient safety is a priority for the TGA. Patients should be encouraged to report all adverse events to the TGA.
Consumers and healthcare professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a healthcare professional if you are concerned about the use, outcomes, risks, possible complications, and possible alternatives.
Regulatory decisions
The below table will be updated regularly, to reflect the findings of the review and any additional actions as the post-market review progresses.
ARTG | SPONSOR | DEVICE/PRODUCT NAME | TGA ACTION | DATE EFFECTIVE |
---|---|---|---|---|
128775 | Boston Scientific Pty Ltd | PRECISION Linear 8 Contact Leads (model SC-2138-xx) | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
218230 | Boston Scientific Pty Ltd | CoverEdge MRI 32 Contact Surgical Lead Kit - Electrode/lead, stimulator, implantable, neurological | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
275241 | Boston Scientific Pty Ltd | Infinion CX Lead - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
287236 | Boston Scientific Pty Ltd | Avista MRI 8 Contact Lead Kit - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
287237 | Boston Scientific Pty Ltd | Freelink Remote Control Kit - Implantable spinal cord electrical stimulation system programmer | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
287738 | Boston Scientific Pty Ltd | Freelink Remote Control - Implantable spinal cord electrical stimulation system programmer | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
308180 | Boston Scientific Pty Ltd | Artisan MRI 2x8 Surgical Lead Kit - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
318330 | Boston Scientific Pty Ltd | Freelink Remote Control Model SC-5260 - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
318331 | Boston Scientific Pty Ltd | Freelink Remote Control Kit Model SC-5562-1A - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
362972 | Boston Scientific Pty Ltd | WaveWriter Alpha 16 IMPLANTABLE PULSE GENERATOR KIT - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
362973 | Boston Scientific Pty Ltd | WaveWriter Alpha IMPLANTABLE PULSE GENERATOR KIT - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
362974 | Boston Scientific Pty Ltd | Freelink Remote Control Kit - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
362991 | Boston Scientific Pty Ltd | Freelink Remote Control - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
400291 | Boston Scientific Pty Ltd | Precision Montage MRI 16 Contact Implantable Pulse Generator Kit (Model SC-1200) - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
400292 | Boston Scientific Pty Ltd | WaveWriter Alpha Prime 16 IMPLANTABLE PULSE GENERATOR KIT - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
400373 | Boston Scientific Pty Ltd | WaveWriter Alpha Prime IMPLANTABLE PULSE GENERATOR KIT - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
400374 | Boston Scientific Pty Ltd | WaveWriter Alpha 16 IMPLANTABLE PULSE GENERATOR KIT - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
400392 | Boston Scientific Pty Ltd | WaveWriter Alpha IMPLANTABLE PULSE GENERATOR KIT - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 3 January 2024 |
369212 | RQSolutions Medical Device Distribution Support | Nalu Neurostimulation System Programmer 43009 – Implantable spinal cord electrical stimulation system programmer | The device has been cancelled from the ARTG. The sponsor provided insufficient information to demonstrate compliance with the Essential Principles. | 19 June 2024 |
369214 | RQSolutions Medical Device Distribution Support | Nalu Neurostimulation System Therapy Disc 34001-001 – Implantable spinal cord electrical stimulation system programmer | The device has been cancelled from the ARTG. The sponsor provided insufficient information to demonstrate compliance with the Essential Principles. | 19 June 2024 |
369213 | RQSolutions Medical Device Distribution Support | Nalu Stimulation leads 12001-060 – Stimulator, electrical, analgesic, spinal cord | The device has been cancelled from the ARTG. The sponsor provided insufficient information to demonstrate compliance with the Essential Principles.) | 19 June 2024 |
369510 | RQSolutions Medical Device Distribution Support | Nalu Neurostimulation Kit - Stimulator, electrical, analgesic, spinal cord | The device has been cancelled from the ARTG. The sponsor provided insufficient information to demonstrate compliance with the Essential Principles. | 19 June 2024 |
369211 | RQSolutions Medical Device Distribution Support | Nalu Lead Anchor 13001 - Anchor, soft-tissue implanted, non-biodegradable | The device has been cancelled from the ARTG. The sponsor provided insufficient information to demonstrate compliance with the Essential Principles. | 19 June 2024 |
385510 | RQSolutions Medical Device Distribution Support | Analgesic spinal cord electrical stimulation system pulse generator implantable | The device has been cancelled from the ARTG. The sponsor provided insufficient information to demonstrate compliance with the Essential Principles. | 19 June 2024 |
385570 | RQSolutions Medical Device Distribution Support | Implantable lumbar neuromuscular electrical stimulation system lead | The device has been cancelled from the ARTG. The sponsor provided insufficient information to demonstrate compliance with the Essential Principles. | 19 June 2024 |
385572 | RQSolutions Medical Device Distribution Support | Implantable lumbar neuromuscular electrical stimulation system lead | The device has been cancelled from the ARTG. The sponsor provided insufficient information to demonstrate compliance with the Essential Principles. | 19 June 2024 |
185993 | Nevro Medical Pty Ltd | Lead Extension Kit - Electrode/lead, stimulator, implantable, neurological | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
185995 | Nevro Medical Pty Ltd | Programmer Wand Kit - Active-implantable-device communicator | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
186000 | Nevro Medical Pty Ltd | Programmer Kit - Active-implantable-device communicator | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
186043 | Nevro Medical Pty Ltd | Senza IPG Kit - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
190837 | Nevro Medical Pty Ltd | IPG PORT PLUG KIT ACCK7000 - Pacemaker/defibrillator port safety plug | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
199081 | Nevro Medical Pty Ltd | S8 Lead Adaptor Kit - Electrode/lead, stimulator, implantable, neurological | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
204062 | Nevro Medical Pty Ltd | M8 Lead Adaptor Kit - Electrode/lead, stimulator, implantable, neurological | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
284256 | Nevro Medical Pty Ltd | Surgical Lead Kit – Model LEAD30yyxx(B) - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
330704 | Nevro Medical Pty Ltd | Senza Omnia IPG Kit - NIPG2500 - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
330705 | Nevro Medical Pty Ltd | Programmer Kit - CLPG2000 - Implantable spinal cord electrical stimulation system programmer | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
330706 | Nevro Medical Pty Ltd | Programmer Kit - CLPG2500 - Implantable spinal cord electrical stimulation system programmer | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
330707 | Nevro Medical Pty Ltd | Patient Remote Kit - PTRC2300 - Implantable spinal cord electrical stimulation system programmer | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
330708 | Nevro Medical Pty Ltd | Patient Remote Kit - PTRC2500 - Implantable spinal cord electrical stimulation system programmer | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGAat specified time points. | 28 June 2024 |
368530 | Nevro Medical Pty Ltd | Surpass-C Surgical Lead Kit - Model LEAD200X-YYB - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
375524 | Nevro Medical Pty Ltd | Senza® System - Power supply, battery pack | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
279015 | Abbott Medical Australia Pty Ltd | Proclaim 5 Elite IPG, Model 3660 - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
279016 | Abbott Medical Australia Pty Ltd | Proclaim 7 Elite IPG, Model 3662 - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
282999 | Abbott Medical Australia Pty Ltd | Proclaim 5 IPG, Model 3661 - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
283000 | Abbott Medical Australia Pty Ltd | Proclaim 7 IPG, Model 3663 - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
351631 | Abbott Medical Australia Pty Ltd | Proclaim XR 5 Implantable Pulse Generator Model 3660 - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
351632 | Abbott Medical Australia Pty Ltd | Proclaim XR 7 Implantable Pulse Generator model 3662 - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
387570 | Abbott Medical Australia Pty Ltd | Proclaim 5 IPG, Model 3661 - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
396979 | Abbott Medical Australia Pty Ltd | Proclaim 5 Elite IPG, Model 3660 - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
396982 | Abbott Medical Australia Pty Ltd | Proclaim 7 Elite IPG, Model 3662 - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
396983 | Abbott Medical Australia Pty Ltd | Proclaim 7 IPG, Model 3663 - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
396984 | Abbott Medical Australia Pty Ltd | Proclaim XR 7 Implantable Pulse Generator model 3662 - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
396985 | Abbott Medical Australia Pty Ltd | Proclaim XR 5 Implantable Pulse Generator Model 3660 - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 28 June 2024 |
280179 | Medtronic Australasia Pty Ltd | Specify SureScan MRI 5-6-5 Surgical Lead Kit - Stimulator, electrical, analgesic, spinal cord | The device has been cancelled from the ARTG. The sponsor provided insufficient information to demonstrate compliance with the Essential Principles. | 12 July 2024 |
280180 | Medtronic Australasia Pty Ltd | Specify SureScan MRI 2x8 Surgical Lead Kit - Stimulator, electrical, analgesic, spinal cord | The device has been cancelled from the ARTG. The sponsor provided insufficient information to demonstrate compliance with the Essential Principles. | 12 July 2024 |
392267 | Medtronic Australasia Pty Ltd | AdaptiveStim Implantable Neurostimulator 97715 | The device has been cancelled from the ARTG. The sponsor provided insufficient information to demonstrate compliance with the Essential Principles. | 12 July 2024 |
389797 | Medtronic Australasia Pty Ltd | Vanta with AdaptiveStim Model 977006 - Analgesic spinal cord electrical stimulation system pulse generator implantable | The device has been cancelled from the ARTG. The sponsor provided insufficient information to demonstrate compliance with the Essential Principles. | 12 July 2024 |
230721 | Abbott Medical Australia Pty Ltd | Prodigy IPG 3799 - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 9 August 2024 |
376449 | Abbott Medical Australia Pty Ltd | Prodigy MRI IPG, model 3772 - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 9 August 2024 |
397014 | Abbott Medical Australia Pty Ltd | Prodigy MRI IPG, 16CH, Model # 3772 - Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 9 August 2024 |
397013 | Abbott Medical Australia Pty Ltd | Prodigy MRI IPG, model 3772 - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 9 August 2024 |
336330 | Saluda Medical Pty Ltd | Evoke Closed Loop Stimulator (CLS) - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 7 August 2024 |
336570 | Saluda Medical Pty Ltd | Evoke Pocket Console - Implantable spinal cord electrical stimulation system programmer | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 7 August 2024 |
336572 | Saluda Medical Pty Ltd | Evoke Clinical System Transceiver (CST) - Implantable spinal cord electrical stimulation system programmer | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 7 August 2024 |
336573 | Saluda Medical Pty Ltd | Evoke 12C Percutaneous Lead Kit - Implantable lumbar neuromuscular electrical stimulation system lead | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 7 August 2024 |
338400 | Saluda Medical Pty Ltd | Evoke Clinical Interface (CI) - Implantable electrical stimulation device management software | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 7 August 2024 |
396987 | Abbott Medical Australia Pty Ltd
| Proclaim DRG IPG, Model 3664 - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 22 August 2024 |
333462 | Abbott Medical Australia Pty Ltd
| Proclaim DRG IPG, Model 3664 - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 22 August 2024 |
333463 | Abbott Medical Australia Pty Ltd
| SlimTip DRG Implant Lead Kit, 90cm – Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 22 August 2024 |
333448 | Abbott Medical Australia Pty Ltd
| DRG Lead Extension Kit – Stimulator, electrical, analgesic, spinal cord | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 22 August 2024 |
396986
| Abbott Medical Australia Pty Ltd
| Proclaim DRG IPG, Model 3664 - Analgesic spinal cord electrical stimulation system pulse generator implantable | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 22 August 2024 |
381328 | Abbott Medical Australia Pty Ltd | Quattrode Percutaneous Lead Kit - Implantable lumbar neuromuscular electrical stimulation system lead - Model 3156 | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 21 August 2024 |
374775 | Abbott Medical Australia Pty Ltd | Octrode Lead Kits - Implantable lumbar neuromuscular electrical stimulation system lead – Models 3183, 3189 | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 21 August 2024 |
374776 | Abbott Medical Australia Pty Ltd | Octrode Lead Kit 3186 - Implantable lumbar neuromuscular electrical stimulation system lead – Model 3186 | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 21 August 2024 |
384015 | Abbott Medical Australia Pty Ltd | Lamitrode Tripole Lead, 60cm, Models 3214 and 3219 - Implantable lumbar neuromuscular electrical stimulation system lead | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 21 August 2024 |
377339 | Abbott Medical Australia Pty Ltd | Penta 3mm Lead 60cm Model 3228 - Implantable lumbar neuromuscular electrical stimulation system lead | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 21 August 2024 |
384012 | Abbott Medical Australia Pty Ltd | Lamitrode S-8 Lead Kit, 60cm Length, Model 3286 - Implantable lumbar neuromuscular electrical stimulation system lead | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 21 August 2024 |
384013 | Abbott Medical Australia Pty Ltd | Lamitrode 44 Lead Kit 60cm, Model 3244 - Implantable lumbar neuromuscular electrical stimulation system lead | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 21 August 2024 |
384014 | Abbott Medical Australia Pty Ltd | Lamitrode 4 Lead Kit, 60 cm, Model 3240 - Implantable lumbar neuromuscular electrical stimulation system lead | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 21 August 2024 |
377340 | Abbott Medical Australia Pty Ltd | Lamitrode 88 Lead Kit Model 3288 - Implantable lumbar neuromuscular electrical stimulation system lead | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 21 August 2024 |
375832 | Abbott Medical Australia Pty Ltd | Extension, Dual 4 Channel - Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension – Models 3341, 3343, 3346 | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 21 August 2024 |
375833 | Abbott Medical Australia Pty Ltd | Lead extension - Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension – Models 3383, 3386 | Additional Conditions of Inclusion (COI) have been imposed on the ARTG entry. The COI requires the sponsor to provide additional information, such as additional studies, to the TGA at specified time points. | 21 August 2024 |
The review is ongoing and we will take further regulatory action as needed.