Medtronic Gets FDA OK for Asleep Deep Brain Stimulation Surgery

Medtronic has earned U.S. Food and Drug Administration (FDA) approval for Asleep deep brain stimulation (DBS) surgery for patients with Parkinson’s and patients with essential tremor.
 
This landmark approval makes Medtronic the first, only company to gain an FDA nod for DBS surgery while a patient is asleep (under general anesthesia) or awake.
 
The company said several studies published data on Asleep DBS and compared it with Awake DBS. The data confirmed patients with Parkinson’s achieve comparable improvement in certain motor symptoms whether being asleep or awake for the surgery.
 
Francisco Ponce, MD, neurosurgeon and chief of stereotactic and functional neurosurgery at The Barrow Neurological Institute said Asleep DBS offers a safe, comfortable, and less stressful experience for patients who may be apprehensive about the procedure.
 
“Whether performed asleep or awake, DBS is proven to reduce motor symptoms in movement disorders like Parkinson’s,” Dr. Ponce told the press.
 
DBS uses a surgically implanted medical device, similar to a cardiac pacemaker. Medtronic’s Percept neurostimulators transmit electrical signals via slender wires to specific brain targets affected by debilitating neurological disorders.
 
The Percept family of neurostimulators is the first, only DBS system with sensing, directionality, and advanced programming, the company claims. Medtronic’s DBS system with BrainSense technology captures and records brain signals, giving healthcare providers valuable data and insights to tailor therapy to patients’ individual needs.
 
The company’s Percept RC DBS system, a rechargeable option, received FDA approval in January 2024.
 
“This is a significant advancement in our surgical offering, providing another safe and effective option for patients considering DBS,” said Amaza Reitmeier, vice president and general manager of Medtronic’s Brain Modulation business. “This approval underscores our dedication to continuous innovation to address the needs of patients and healthcare providers.”