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Medtronic Gains FDA Approvals for Percept and Inceptiv Systems

• Medtronic's Percept system, a 'pacemaker for the brain,' received FDA approval for managing movement disorders like Parkinson's disease by sending electrical signals to modulate brain rhythms. • The Inceptiv spinal cord stimulator, designed for chronic pain treatment, secured FDA approval with its unique ability to automatically adjust therapy, enhancing pain relief and maintaining stimulation levels. • Clinical data suggests that a significant percentage of patients undergoing spine operations continue to experience spinal pain, highlighting the need for innovative solutions like Inceptiv. • Analysts anticipate growth for Medtronic due to the launch of the Inceptiv closed-loop spinal cord stimulator, praising its potential impact on the neuromodulation market.

Medtronic has recently secured FDA approvals for two innovative neuromodulation systems: the Percept deep brain stimulation (DBS) system and the Inceptiv spinal cord stimulator. These approvals mark significant advancements in the treatment of movement disorders and chronic pain, respectively.
The Percept system functions akin to a "pacemaker for the brain," as described by Dr. Robert McGovern, a neurosurgeon at M Health Fairview. It delivers electrical signals to modulate brain rhythms, offering a therapeutic approach for managing movement disorders such as Parkinson's disease. Bruce Lunde, an 81-year-old diagnosed with Parkinson's in 2019, experienced a significant reduction in tremors after receiving the latest version of the Percept implant in January. Lunde stated, "With Medtronic’s deep brain stimulation, my tremor ... largely disappeared. I’m delighted with the way things are working. I feel like it can give people hope."
In April, Medtronic also obtained FDA approval for Inceptiv, a spinal cord stimulator designed for treating chronic pain. This device stands out due to its ability to automatically adjust therapy, aiming to provide enhanced pain relief while maintaining the stimulation level prescribed by a physician. Dr. Ashwini Sharan, chief medical officer for Medtronic’s neuromodulation business, noted that approximately 30% of patients undergoing spine operations continue to experience spinal pain, underscoring the need for innovative pain management solutions.
Robbie Marcus, an analyst with J.P. Morgan, highlighted the potential growth for Medtronic following the launch of Inceptiv, stating, "Growth is anticipated above market in the coming quarters off of the launch of the Inceptiv closed-loop [spinal cord stimulator]."
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[1]
Medtronic scores FDA approvals for several new therapies to drive sales - Star Tribune
startribune.com · Sep 12, 2024

Dr. Robert McGovern implanted the latest Percept system in Bruce Lunde, treating his Parkinson's tremors. Medtronic also...

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