USFDA approves Medtronic Percept RC Deep Brain Stimulation system
Dublin: Medtronic plc has announced the U.S. Food and Drug Administration (FDA) approval of its Percept RC Deep Brain Stimulation (DBS) system.
The rechargeable neurostimulator is the latest innovation in the Medtronic Percept family, which includes the Percept PC neurostimulator, BrainSense technology†, and SenSight directional leads. The Percept family is the only sensing-enabled DBS system on the market, allowing the physician to personalize treatment for patients with movement disorders such as Parkinson's disease, essential tremor, and dystonia as well as epilepsy. Over 11 million people in the U.S. are living with movement disorders and approximately 3.4 million with epilepsy.
"Our DBS therapy with exclusive BrainSense technology can help control debilitating tremors for people living with Parkinson's, providing patients with the ability to physically engage in everyday moments – something many of us unintentionally take for granted," said Amaza Reitmeier, vice president and general manager, Brain Modulation within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "We are transforming brain modulation through sensing-enabled DBS and will continue to drive therapy innovation with the goal of many more peoples' lives improved with Medtronic DBS therapy."
DBS uses a surgically implanted medical device, similar to a cardiac pacemaker. Medtronic Percept neurostimulators transmit electrical signals via slender wires to specific brain targets affected by debilitating neurological disorders like Parkinson's disease.
"Percept RC is the smallest and thinnest dual channel‡ neurostimulator available for DBS. It is equipped with BrainSense technology that captures and records brain signals to provide insights that enable a healthcare provider to adapt and personalize therapy to a patient's evolving needs. Unlike other rechargeable devices, the Percept RC battery offers at least 15 years of service life with consistent and fast recharge performance. Medtronic patented battery technology has less battery fade than other rechargeable devices for a more reliable, long-lasting battery.§ Patients can experience rapid recharging from 10% to 90% full charge in less than an hour.Ω," the Company stated.
"While more data are needed, the sensing capability of this unique deep brain stimulation system allows me the potential to tune stimulation delivery to brain activity, which may be a way to personalize this therapy for Parkinson's disease in the future," said Casey H. Halpern, M.D., Neurosurgeon and deep brain stimulation expert.
Nearly 70 percent of all DBS-eligible patients are estimated to require an MRI as part of their essential care.
Percept offers greater freedom and scan access for patients with 3T scans and best-in-class 1.5T MRI scan labeling. In addition, the Percept neurostimulators are engineered to allow for future software updates designed for the Percept platform without a neurostimulator device exchange.
"This new rechargeable neurostimulator technology provides me with insights into my patients' symptoms and can capture data even when they're outside of the clinic," said Eleni Okeanis Vaou, M.D., FAAN, associate professor of neurology. "Now I have a rechargeable DBS therapy option with sensing technology allowing me to track a patient's response to DBS and medications. I use this data to inform how to personalize and optimize patient therapy."
Dr. Vaou is a deep brain stimulation expert with the University of Texas Health Science Center at San Antonio (UT Health San Antonio) and is not affiliated with Medtronic. She and the institution do not endorse products or services.
Percept RC is available immediately throughout the U.S., as well as via CE Mark approval in Europe and availability in Japan.
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