But unpublished real-world data Medtronic collected from a much larger group of patients reveals the Intellis works so poorly, it may provide no meaningful benefit to patients at all, according to an analysis by the regulator, while exposing patients to serious risks.<\/p>\n<\/p>\n
\u201cThe performance data is substantially worse than the performance in the manufacturer\u2019s published studies,\u201d a government auditor wrote in a confidential Therapeutic Goods Administration report obtained by this masthead using freedom of information laws.<\/p>\n
\u201cThese results are very concerning and conflict with the study results. The improvements are so small that it is unclear whether these actually constitute a \u2018benefit\u2019 at all.<\/p>\n
\u201cIt is impossible to see how patients can give meaningful informed consent in this setting, nor how prescribers can make reasonable recommendations about care.\u201d<\/p>\n
The Intellis was approved for sale by the TGA in 2018, and was the most popular stimulator sold in the private health system that year.<\/p>\n
Related Article The new data, submitted to the TGA years after the device was approved, made clear it did not meet Australian standards, the auditor concluded \u2013 and the studies backing it were \u201csmall\u201d and poorly designed.<\/p>\n Marcus Barlow received an Intellis in 2019 to treat chronic lower back pain. It did not help, despite his doctor repeatedly adjusting the stimulation. The bulky metal device pressed on his spine and interfered with his sleep.<\/p>\n \u201cI thought I had a very high chance of it working in me. I thought spinal cord stimulators were a safe, non-invasive treatment,\u201d Barlow said.<\/p>\n Had he known the actual success rates in Medtronic\u2019s internal data, he said he \u201cabsolutely\u201d would not have gone ahead with the operation. \u201cThey have misled patients,\u201d he said. \u201cI feel horrified about this.\u201d<\/p>\n Rachel David, chief executive of Private Healthcare Australia, described the revelations about Medtronic\u2019s internal data as \u201cdisturbing\u201d.<\/p>\n \u201cMedical device companies should be compelled to report their own data on complaints and adverse events to the TGA in a timely way,\u201d she said. \u201cIf we can\u2019t trust medical device companies to do this, the TGA needs to consider tougher penalties for non-compliance.\u201d<\/p>\n This masthead\u2019s Medical Malfunctions<\/a> series has revealed weak medical device regulations that allow sometimes untested technology to be put into the bodies of Australians, and fails to pick up problematic technology when it fails inside patients\u2019 bodies.<\/p>\n The uncovered documents have turned the spotlight on the huge medical device companies that sell billions of dollars<\/a> of pacemakers, insulin pumps and spinal cord stimulators every year.<\/p>\n A Medtronic spokesman said it was common for real-world and clinical trial data to differ.<\/p>\n Medtronic was \u201ccommitted to patient safety, transparency and ongoing evidence generation\u201d, he said.<\/p>\n It is not the first time the medtech giant has been accused of concealing data.<\/p>\n It ran a study that collected more than 1000 adverse events linked to a bone-fusion product called Infuse, including deaths. The company shut the study down in 2008 but only reported the injuries to US regulators in 2013.<\/p>\n Medtronic said that was due to a filing error<\/a>, but paid US$12 million in 2017 to settle allegations by US attorneys-general that its Infuse marketing \u2013 including studies that downplayed side effects \u2013 was false and misleading<\/a>. The company did not admit wrongdoing; it pulled the product from the Australian market in 2020.<\/p>\n The stimulators, the \u2018weak\u2019 studies and the real-world data<\/p>\n Earlier this decade \u2013 the TGA refuses to reveal when \u2013 Medtronic applied to Australian regulators to register a new model of spinal cord stimulator, the Inceptiv.<\/p>\n Spinal cord stimulators are essentially small computers wired into the spinal nerves, often used to treat back pain or chronic pain.<\/p>\n In theory, electrical pulses can interfere with pain signals. The Inceptiv contains new technology allowing it to monitor and automatically change its output.<\/p>\n The TGA claims every approved medical device in Australia has clinical evidence showing it is safe and works<\/a>.<\/p>\n Medtronic did not present any clinical studies of the Inceptiv. Instead, it relied on \u201cequivalence\u201d, which allows companies to win approval for new medical devices if they argue they are essentially identical to older, already registered devices.<\/p>\n Medtronic claimed the Inceptiv was \u201cequivalent\u201d to the Intellis, the stimulator it won approval for in 2018 and which Marcus Barlow had installed.<\/p>\n The Intellis was the most-popular stimulator in Australia in 2018-19, with each installation costing about $50,000, according to private health insurance data. About 1050 patients have received them in private hospitals since the device launched.<\/p>\n<\/p>\n Medtronic supplied two studies of the Intellis to the TGA to make the argument it was safe and effective \u2013 and, by extension, so was the Inceptiv.<\/p>\n The first study concluded that 80 per cent of patients cut their back pain by 50 per cent after three months; Medtronic promotes that trial on its website. The TGA\u2019s assessor described both studies as \u201csmall with weak designs\u201d.<\/p>\n However, Medtronic\u2019s application also included data from its Product Surveillance Registry \u2013 real-world data from patients using the device around the world.<\/p>\n The registry contains more patients than all the studies Medtronic submitted, combined, and tells \u201ca remarkably different story\u201d, in the words of the TGA assessor.<\/p>\n In the real-world data, just 27 per cent of patients cut their back pain in half. Patients said the stimulator had improved their overall health by less than 5 per cent.<\/p>\n \u201cThese results are very concerning and conflict with the study results,\u201d the assessor wrote.<\/p>\n \u201cThe data presents two conflicting pictures of device performance. In manufacturer studies which have been published, or which the manufacturer intends to publish, the device appears to be moderately to highly effective. In the larger real-world dataset which the manufacturer has collected but not published, the device performs poorly.\u201d<\/p>\n![\"Fiona](\"https:\/\/www.newsbeep.com\/au\/wp-content\/uploads\/2026\/09\/2e37ed62997c71e6d2fc94f511fcb8463c03de78.jpeg\")
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