Medtronic receives FDA approval for Inceptiv™ closed-loop spinal cord stimulator
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Medtronic's newly FDA-approved Inceptiv™ spinal cord stimulator introduces a paradigm shift in pain management technology. Traditional spinal cord stimulators provide constant electrical impulses, but the closed-loop system of Inceptiv adjusts stimulation based on physiological changes. This advancement may lead to improved patient outcomes and increased adoption rates. Considering Medtronic's market presence and expertise in medical devices, the introduction of a more responsive system could potentially expand their market share and drive long-term revenue growth.
From a financial standpoint, Medtronic could see an increase in sales figures as this technology becomes mainstream. The company's R&D investments into developing advanced systems like Inceptiv are likely to be viewed positively by investors. However, the initial costs may be high and it will take time to gauge the market's response. The long-term benefits hinge on clinical outcome data, reimbursement rates and the ability of healthcare providers to integrate such technology into their practices.
The approval of the Inceptiv™ system indicates a growing trend towards personalized medicine in the field of chronic pain management. As the first of its kind with a closed-loop system, it may set a new standard in the industry. The technology's ability to adjust based on the patient's physical activity and pain levels could lead to wider acceptance among practitioners and patients alike. Market dynamics suggest a positive response to innovations that enhance quality of life, which could be favorable for Medtronic's stocks.
Investors should monitor peer-reviewed clinical data and patient feedback as these will be critical in assessing the long-term impact of the technology on the company's financial health. Furthermore, as regulations and healthcare policies evolve, Medtronic's ability to navigate the landscape will be important in determining the Inceptiv's success within the marketplace.
Closed-loop sensing capability instantly and automatically adjusts therapy while treating chronic pain
"Pain is intensely personal, and stimulation therapy should meet the needs of every patient, moment to moment," said Dr. Krishnan Chakravarthy, M.D., Ph.D., Director of Innovative Pain Treatment Solutions and Surgery Center, VA San Diego Healthcare, and Chairman of the Empower You Chronic Pain Foundation. "Inceptiv listens to what the body is saying and, more quickly than you can blink, it seamlessly adjusts. This represents an important leap forward for the treatment of chronic pain."
Traditional fixed-output SCS devices deliver constant, mild electrical impulses that disrupt pain signals before they reach the brain. As patients go about their daily lives, certain movements such as laughing, bending, or sneezing may result in brief moments of uncomfortable overstimulation. This in turn may lead some patients to turn down their device's stimulation output, resulting in a suboptimal therapy experience.
By contrast, Inceptiv SCS senses biological signals and consistently maintains the physician's prescribed stimulation that is tailored to a patient's needs. Specialized circuitry and a proprietary algorithm detect ECAPs (Evoked Compound Action Potentials), signals generated by the spinal cord in response to electrical stimuli. ECAPs are a direct measure of how much nerve tissue is activated in the spinal cord and can be used to inform real-time adjustments to stimulation. Inceptiv SCS senses the body's response to stimulation† 50 times per second and instantly increases or decreases stimulation to maintain prescribed settings as determined by the physician.
The Inceptiv system delivers additional advantages beyond its closed-loop capability. Inceptiv offers unparalleled access to diagnostic imaging, with 1.5T and 3T full-body MRI access with no power or impedance restrictions.‡ It is the only FDA-approved closed-loop spinal cord stimulator that offers full-body 3T MRI access. Up to
"A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront," said David Carr, vice president and general manager, Pain Interventions within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "For patients dealing with chronic pain, every day is a struggle. They deserve personalized and effective relief, without compromising future access to MRI. They deserve the comfort that the smallest and thinnest device on the market can provide. We are proud to offer the most cutting-edge solution available today with Inceptiv SCS."
Medtronic will initiate the U.S. market launch of Inceptiv in the coming weeks. The system previously earned approvals for sale in
† Sensing signals may not be measurable in all cases |
‡ Under certain conditions. Refer to product labeling for full list of conditions. |
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin,
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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1 Desai, Mehul J., et al. "The rate of magnetic resonance imaging in patients with spinal cord stimulation." Spine, vol. 40, no. 9, 2015, https://doi.org/10.1097/brs.0000000000000805. |
2 Fishman, M, Cordner, H, Justiz, R, Provenzano, D, Merrell, C, Shah, B, et al. Twelve-Month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain. Pain Pract. 2021; 21: 912– 923 |
3 DTM™ SCS outcomes demonstrated using open-loop SCS |
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