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Vercise

Manufactured by Boston Scientific
Sourced in United States

The Vercise is a medical device designed for use in laboratory settings. It is a piece of equipment intended to aid in scientific research and experimentation. The core function of the Vercise is to provide a controlled and monitored environment for various tests and procedures. Further details on the specific intended use of this product are not available.

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5 protocols using vercise

1

Deep Brain Stimulation for Parkinson's Disease

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Prior to the commencement of data collection, the full protocol was approved by the Human Research Ethics Committees of the Royal Brisbane & Women’s Hospital, the University of Queensland, the QIMR Berghofer Medical Research Institute and UnitingCare Health. All research was performed in accordance with relevant guidelines and regulations. All participants gave written, informed consent to participate in the study.
Thirty-eight participants with PD undertaking STN-DBS were consecutively recruited at the Asia-Pacific Centre for Neuromodulation in Brisbane, Australia. All participants met the UK Brain Bank criteria for PD45 (link). No participants met the Movement Disorder Society criteria for dementia46 (link). The PD subtype and the Hoehn and Yahr stage at device implantation was recorded47 (link). Patients underwent bilateral implantation of Medtronic 3389 or Boston Vercise electrodes in a single-stage procedure. Stimulation was commenced immediately using microelectrode recording data to identify the optimal contact. Further contact testing took place over the following week as an inpatient, with participants returning to the DBS centre following discharge for further stimulation titration, guided by residual motor symptoms. Further details have previously been reported48 (link),49 (link).
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2

Advanced PD Patients Treated with DBS

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Ten patients (6 male, 4 female, age 56.8 ± 5.6 years) suffering from advanced idiopathic PD (disease duration 6–15 years) participated in the study. They were treated with implantation of a linear octopolar electrode for DBS (Boston Scientific, Natick, MA, USA) and a rechargeable implantable pulse generator (Vercise™, Boston Scientific, Natick, MA, USA). We included patients with ages between 18 and 70 years, diagnosed with idiopathic PD (according to the British Brain Bank criteria) at an advanced stage, with a good response to levodopa but with refractory fluctuations and medication-induced dyskinesia, and with a disease duration of more than 5 years. All patients were candidates for DBS of the STN and SNr and had clinical, radiological and electrophysiological testing that verified the proper placement of electrodes in STN and SNr. Dopaminergic medication intake was unchanged for at least 4 weeks before surgical intervention. All patients signed informed consent before intervention. Exclusion criteria: pregnancy or planning to become pregnant during the course of the study, cognitive impairment (Mini-Mental State Exam under 25), participation in another study during the clinical trial or 3 months before, serious psychiatric or other severe pathological condition and acute adverse events arising from STN + SNr-DBS.
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3

Bilateral GPi-DBS for Cervical Dystonia

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Twelve dystonia patients with bilateral GPi‐DBS treatment participated into the study. All patients had isolated cervical dystonia at the time of diagnosis. However, as focal dystonias frequently spread to other body parts,14 our two patients (patients 11 and 12) exhibited spread of dystonia symptoms to segmental dystonia (the affected body parts were neck, mouth and eyes) or generalized dystonia (the affected body parts were neck, mouth, vocal cords, trunk, left upper limb and left lower limb). Ten (83%) of 12 patients remained as isolated cervical dystonia at the time of the study. In all cases, treating clinicians had referred patients to DBS center due to of troubling cervical dystonia and insufficient response to other treatments like botulinum toxin injections. All patients were implanted with bilateral GPi‐DBS electrodes (Medtronic Activa PC, n = 8; Abbott St. Jude Infinity, n = 3; or Boston Scientific Vercise, n = 1). Voltages (V) in devices operating in current mode (Abbott) were calculated using current (mA) and resistance (ohms). This information was not available for the Boston Scientific device (n = 1).
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4

Deep Brain Stimulation Procedure

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The general surgical procedure has been published in detail before. Patients are operated under local anesthesia with sedation (remifentanil and propofol).
In summary, after fixation of the stereotactic frame (CRW Stereotactic System, Integra Neurosciences, or Riechert-Mundinger frame), planning is performed on fused stereotactic CT/MRI images, with the Framelink (Medtronic Inc.) or STP 3.5 (Leibinger) planning station.
The trajectory is planned so that both VIM and PSA can be stimulated, with one electrode contact on the AC-PC level. Macrostimulation is performed in all patients. Microrecording is selected in a number of patients based on the surgeon’s preference. Implanted electrodes are quadripolar electrodes from Medtronic Inc. (model 3387 or 3389) or octopolar electrodes from Boston Scientific (model 616010).
Finally, the pulse generator (Activa PC, model 37601; Activa RC, model 37612, Medtronic, USA or Vercise, Boston Scientific, USA) is implanted subcutaneously in the infraclavicular or lateral abdominal region under general anesthesia.
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5

Cerebellar Neuromodulation for Movement Disorders

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Participants underwent stereotactic implantation of a single DBS lead in the area of the cerebellar DN contralateral to the lesioned cerebral hemisphere using a frame-based technique similar to that used in DBS for movement disorders (Supplementary Fig. 1)39 (link). All participants received an 8-channel lead (Vercise or Vercise Cartesia, Boston Scientific) with electrode arrays up to 15.5 mm in length. Additional surgical details are provided in the Supplementary Information.
Between the rehab-only and the DBS + rehab phases, participants underwent up to 16 programming visits. First, a traditional monopolar review was performed to characterize stimulation-related side effects for each of the eight contacts of the DBS lead and delineate the upper limit of the parameter space. Thereafter, the acute effects of DN-DBS on motor task execution and task-related electroencephalography were examined according to specified combinations of electrode polarity, pulse frequency, pulse width and pulse amplitude.
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