Author(s): Allyne Topaz, MD; Luca Milone, MD
Boston Scientific Corporation received FDA approval for the Vercise Deep Brain Stimulation (DBS) System on December 8, 2017.
The Vercise DBS System is an implantable, rechargeable neurostimulator that reduces motor symptoms associated with moderate to advanced levodopa responsive Parkinson’s disease. Implanted near the clavicle, it generates various combinations of low intensity electrical pulses through leads connected to the bilateral subthalamic nucleus region of the brain. This device is controlled via a handheld remote and programmed by a clinician using the Bionic Navigator™ Software. The stimulator battery must be recharged using a radiofrequency (RF) device provided.
The INTREPID and the VANTAGE Studies were the basis for device approval.
The INTREPID study evaluated safety and effectiveness, while the VANTAGE study evaluated safety alone.
FDA approved alternative DBS devices currently marketed in the United States are: Medtronic Activa®PC, Activa®RC, Activa®SC, and the St. Jude Medical Infinity Neurostimulation Systems.
Indications:
The Vercise DBS System is indicated for motor symptoms not adequately controlled with medication for moderate to severe levodopa responsive Parkinson’s disease.
Contraindications:
The Vercise DBS System is contraindicated during concomitant use of ultrasound diathermy, electroconvulsive therapy, and transcranial magnetic stimulation. Additionally, patients with the Vercise DBS system should avoid MRI exposure. Furthermore, if patients are unable to operate the remote control and charging system; the device should not be implanted. Poor surgical candidates should not have the device; and patients with poor test simulations should not receive the device.
References:
- Timmermann L, Jain R, Chen L, Maarouf M, Barbe MT, Allert N, Brücke T, Kaiser I, Beirer S, Sejio F, Suarez E, Lozano B, Haegelen C, Vérin M, Porta M, Servello D, Gill S, Whone A, Van Dyck N, Alesch F. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson’s disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Lancet Neurol. 2015 Jul;14(7):693-701. PubMed PMID: 26027940.
- Deep Brain Stimulation (DBS) for the Treatment of Parkinson’s Disease (INTREPID) ClinicalTrials.gov Identifier: NCT01839396
