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Leadpoint system

Manufactured by Medtronic
Sourced in United States

The Leadpoint system is a medical device used to monitor and record cardiac electrical signals. It is designed to assist healthcare professionals in the diagnosis and management of cardiac conditions. The Leadpoint system collects and analyzes data from the patient's heart, providing detailed information about the electrical activity and function of the heart.

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6 protocols using leadpoint system

1

Deep Brain Stimulation of Subthalamic Nucleus in Parkinson's Disease

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Nine participants (five male, four female) with idiopathic PD who were considered suitable for the implantation of bilateral permanent stimulators in the STN were included in this study. The patient age was 67 ± 5 years, with disease duration of 14 ± 6 years. Participants were all right handed and had no further neurological impairment. The participants had undergone psychiatric screening prior to DBS surgery. A summary of the patients is given in Appendix A1.
The dorsolateral aspect of the STN was targeted using a Cosman-Roberts-Wells frame-based stereotactic frame with coordinates based on CT images fused with 3T MRI t1 and FLAIR sequences. The electrode placement was confirmed interoperatively by an MER. The surgical procedure is described in detail in [6] . Tungsten microTargeting R electrodes (model mTDWAR, FHC, Bowdoinham, ME) with a tip diameter of less than 50µm were used for the MER acquisition. The electrodes had a typical impedance of 0.5(±0.15)M Ω at 1kHz. A LeadPoint TM system (Medtronic Inc., Minneapolis,MN) was used to record the signals at a sampling rate of 24kHz. Three filters applied (high pass: 500Hz first order, low pass: 5kHz first order and anti-aliasing: 5KHz fourth order) as recommended by Medtronic. Each MER was recorded during resting phases, when the participant was lying still and not performing any cognitive or movement tasks.
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2

Microrecording for Neuronal Response

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Continuous physiological recordings began at 10 mm above the target and were performed by means of a Medtronic LeadpointTM system (Medtronic Inc., Minneapolis, MN, USA). An exploratory trajectory was made by extruding the microelectrode (250 lm tip, and impedance 1-1.5 MX; FHC Inc., Bowdoinham ME, USA). Microrecording tracks are performed with 0.5 mm steps, and 1\2 mm beyond the target along the single planned trajectory. In order to investigate the neuronal response properties in well isolated neurons, stimuli such as light touch, pressure to the skin, pin prick and passive movements were systematically delivered to the whole body and contralateral, to the recording site, arms and legs (Cordella et al., 2010) .
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3

Deep Brain Stimulation Targeting Methodology

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Preoperative MRI and stereotactic CT images were fused using the StealthStation Surgical Navigation System (Medtronic, Minneapolis, MN, USA) to plan lead trajectory. Target coordinates for the PSA were determined as a point 2–3 mm lateral to the equator of the red nucleus, halfway to the sub-thalamic nucleus, 4–6 mm below the intercommissural plane. The trajectory was planned to avoid vessels, sulci, and ventricles. We performed intraoperative microrecording and microstimulation (Leadpoint-system, Medtronic) to verify the target coordinates, and the most-ventral contact of the DBS lead was positioned at this point. Table 1 lists the neurostimulator and lead types for each patient. All patients were implanted bilaterally. Following surgery, electrode placement was verified by an independent neurosurgeon using postoperative CT fused with the preoperative MRI.
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4

Deep Brain Stimulation Surgical Planning

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MRI at 3 Tesla (fluid‐attenuated inversion recovery [FLAIR] and T1 sequences) was acquired preoperatively in the axial plane (Table 1). For 13 cases, T1 images were not available. Bilateral implantation was performed with the patient awake using Medtronic 3387 DBS leads (four ring electrodes with 1.5 mm spacing) (Figure 1A). Surgical planning was performed by the neurologist (WT) on a Stealth Surgical Navigation System (Medtronic, Dublin, Ireland). Planning aimed to achieve a trajectory passing through the dorsal STN before reaching a termination point in the ventral STN midway between the medial‐lateral extent of the STN at the Bejjani line. Implantation was assisted by single‐ and multiunit recordings using the LeadPoint System (Medtronic) captured by microelectrodes (FHC, Bowdoin, Maine, USA). Postoperative CT imaging was acquired in the axial plane (Table 1) within 24 hours after surgery.
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5

Stereotactic Deep Brain Stimulation Procedure

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The surgical procedure was similar to that reported in previous studies [13 (link), 14 (link)]. Anti-Parkinsonian medications were not stopped preoperatively. A stereotactic Leksell G frame (Elekta) was mounted on the head under local anesthesia. A 1.5 T brain MRI was performed (General Electric Medical Systems). The 3-D fast spoiled gradient-echo (FSPGR) sequence was used for anterior commissure (AC)–posterior commissure (PC) calculations. T2 spin-echo images were obtained to define the boundaries of the STN. SurgiPlan (Elekta) was used to run the simulations for targeting the sensorimotor region of the STN and selecting the trajectories. MERs were performed by means of a Leadpoint system (Medtronic) under general anesthesia. The depth of sedation was monitored by the bispectral index under total intravenous anesthesia with propofol and remifentanil. The propofol concentration was titrated to maintain the bispectral index value of 60–80. Permanent model 3389 (Medtronic) quadripolar electrodes were implanted along the proper trajectory to stimulate more sensorimotor regions of the STN, which was localized by both preoperative brain MRI and intraoperative MER. Left DBS was performed first, followed by right DBS. Programmable pulse generators (Medtronic) were implanted in the subclavicular region and connected to the electrodes.
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6

Thalamic Nuclei Mapping via MER

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Single-channel MERs were acquired with a LeadPoint system (Medtronic, Ireland).
MERs were performed along 32 surgical trajectories from 16 patients, yielding 410 recording sites. Average recording duration across individual sites was 7s (range=3-12s). An average of 13 MERs were acquired per trajectory, typically beginning 10-12mm above the target and advancing in 1mm steps until reaching a depth of 1-3mm below target. MERs' anatomical locations were determined by plotting their depths in mm (with respect to the target) along the CT-reconstructed lead trajectories [22] , and then assigning them to the closest nucleus defined by the Krauth/Morel thalamic atlas [17] .
Most MERs (361/410) were located in three nuclei sampled along the trajectory: 135 were in VL, 170 in CM, and 56 in PF. We excluded the remaining MERs from further analysis because they were located in other nuclei that each contained <5% of the total number of MERs. Three-dimensional coordinates of all included MERs are plotted in Figure 4A.
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