FDA approves Asleep Deep Brain Stimulation surgery for Parkinson’s, essential tremor
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The FDA has approved Medtronic’s Asleep Deep Brain Stimulation surgery for individuals diagnosed with Parkinson’s disease as well as those with essential tremor, according to the manufacturer.
It is the first deep brain stimulation (DBS) system that is approved for use in patients who are awake or put under general anesthesia, the company said in a press release.
Medtronic’s DBS system, Medtronic Percept, utilizes neurostimulators that transmit electrical signals through slender wires to specific brain targets. Joined with the company’s BrainSense technology, the system allows health care providers more accurate brain signal recordings, from which to tailor individual therapeutic needs, the company said in the release.
Prior clinical data confirmed that patients with PD registered similar motor symptom improvement whether undergoing DBS surgery asleep or awake. Moreover, recent studies demonstrated that Asleep DBS procedures offer improved safety and efficiency compared with its awake counterpart, according to the release.
“This is a significant advancement in our surgical offering, providing another safe and effective option for patients considering DBS,” Amaza Reitmeier, vice president and general manager of Brain Modulation at Medtronic, said in the release. “This approval underscores our dedication to continuous innovation to address the needs of patients and health care providers.”