Medtronic(NYSE: MDT)+ announced that it received CE mark approval for its Percept RC neurostimulation device.
The medtech giant labeled the deep brain stimulation (DBS) device as the smallest and thinnest device on the market. Also rechargeable, the system features BrainSense sensing technology. Medtronic says its launch marks the first release of a rechargeable DBS system with this sensing technology in Europe.
BrainSense technology enables physicians to track patient brain signals and correlate them with patient-recorded events. These include symptoms or side effects associated with diseases such as Parkinson’s disease. Physicians can also correlate to medications, tailoring therapy to a patient’s evolving needs.
“This development represents a critical step in our journey to transform brain modulation through sensing-enabled DBS,” said Amaza Reitmeier, VP and GM for Medtronic Brain Modulation. “We are excited about the potential of Percept RC to provide a comfortable, personalized DBS therapy to those living with Parkinson’s disease, essential tremor and primary dystonia. Percept RC is also the only rechargeable neurostimulator approved to serve patients with epilepsy.”
More about the Medtronic Percept RC technology
Percept RC also features Overdrive battery technology, providing the flexibility to adjust therapy without impacting battery capacity. Medtronic said that, with weekly charging, the device has greater than 99% battery capacity at 15 years. Additionally, rapid recharging means patients can charge under normal conditions (from 10% to 90%) in less than one hour.
Other features include a low-profile design engineered for patient comfort. This design allows for deeper implant depth and minimal device visibility.
Medtronic said Percept is the only DBS therapy family with MR conditional labeling allowing for 3T and 1.5T full-body MRI scans. Patients can undergo these scans without having to turn off their DBS therapy.
The Percept RC platform also has the ability to facilitate expanded capabilities, meaning patients can utilize software updates in the future.
Medtronic’s European indication for the device covers Parkinson’s, essential tremor, primary dystonia and epilepsy. The company already made the device available in Western Europe and plans to launch in additional regions down the line. Percept RC already has availability in Japan, while it remains under FDA review in the U.S.
“In addition to being the smallest DBS device on the market, Percept RC combines proprietary battery technology with our brain-sensing technology,” said Domenico De Paolis, VP of Neuromodulation (International) at Medtronic. “These innovations are the culmination of 30 years of investment in clinical trials and R&D to improve the experience of DBS patients.”