SENSIGHT™ Directional Leads Deep Brain Stimulation (DBS) Directional Lead System
The first-of-its-kind SenSight™ directional DBS lead system combines the benefits of directionality with the power of sensing.1-6 Built with proprietary materials, components, and processes, the SenSight™ directional lead and SenSight™ extension work seamlessly with the Percept™ PC neurostimulator to enhance detection of local field potentials (LFPs), which are 1 million times smaller than DBS stimulation pulses.1
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Overview
NEWLY designed System
With your collaboration and insights, we’ve designed every component of our DBS directional lead system — including the lead, the burr hole device, the extension, and everything in between. It's the only DBS directional lead system with 3T and 1.5T MR Conditional* eligibility.
SENSIGHTTM DIRECTIONAL LEADS
1. 1-3-3-1 electrode configuration to more precisely direct the stimulation
2. 1.5mm and 0.5mm electrode spacing options to suit various targeting and patient needs
3. Completely insulated orientation markers to guide directional programming
SENSIGHT™ DIRECTIONAL LEAD —
PROXIMAL END FEATURES
4. Proximal end of lead inserted into extension
5. Laser-etched markers on the proximal end for identification of left and right leads with bilateral implants
6. Laser-etched insertion line on the lead body, which provides visual confirmation of complete insertion — providing confidence in the connection
SENSIGHT™ EXTENSION
7. Single set screw connection on a non-active contact to minimize steps and protect therapeutic delivery
8. Left and right laser-etched markers and radiopaque marker. Laser-etched markers on the proximal end (not shown) and distal end for bilateral implants, for identification of left and right extensions. Extensions with the laser-etched markers also include a radiopaque marker visible under CT, fluoroscopy, X-ray, and O-arm™ Imaging System, for distinguishing with bilateral implants†
SENSIGHT™ BURR HOLE DEVICE
- 14.7% lower profile§ — for your patient’s comfort
- 57% improved lead tip stabilization‖
- Clip designed with vertically elongated securing mechanism with ribs to increase the surface area holding force and minimize lead rotation once secured
- Flexible — designed to be placed in any orientation and conform to the patient’s skull
PRODUCT SPECIFICATIONS
SenSight™ Directional Lead Kit B33005 and B33015
COMPATIBLE WITH:
| Devices
|
B35200 Percept™ PC |
|---|---|
| Extensions
|
B34000 SenSight™ |
| Implant Tools
|
B31010 SenSight™ Depth Stop and Cranial Tunneler Kit |
| Burr Hole Device
|
B31000 SenSight™ Burr Hole Device |
| Clinician Programmer
|
CT900D |
Compatibility Warning: Only use SenSight™ components with other SenSight™ components, unless specific compatibility is stated in product labeling. Do not use incompatible components. Using incompatible components may result in component damage, intermittent or loss of stimulation, and require surgical replacement or revision.
DEVICE SPECIFICATIONS FOR THE DIRECTIONAL LEADSa:
| Description (No Marker) |
Model B33005 or B33015 |
|---|---|
| Description (Bilateral Marker) |
Model B33005M or B33015M |
| Conductor Resistanceb,c |
Maximum 100 Ω for all lengths |
| Length |
Available in 33 and 42 cm lengths (e.g. B3300533 or B3300533M) |
| Surface Area |
33 cm length: 13.55 cm² 42 cm length: 17.26 cm² |
| Lead diameter |
1.36 mm |
| Shape |
Straight |
| Distal end Electrode shape Distal tip distance |
8 electrodes Cylindrical 1.0 mm |
| Proximal end Lead contact spacing Stylet handle length |
8 contacts, in-line 2.2 mm 4.6 mm |
| Materials and substances to which the patient can be exposedd,e |
Polyurethane, Platinum iridium |
a. All measurements are approximate.
b. Electrical resistance of this device only.
c. Electrical resistance is proportional to lead length: long lengths have higher resistance that may limit the amplitude.
d. Discuss allergies or other intolerances related to the materials of construction with the patient before the procedure.
e. Tested for category 1A or 1B carcinogenic, mutagenic, or toxic for reproduction. (CMR)substances, and endocrine disrupting chemicals (EDC). No known CMRs or EDCs found for the materials and substances listed in this table.
SenSight™ directional leads identified with the letter M after the length (e.g. B3300533M), include 2 bilateral markers. Bilateral markers help differentiate between hemispheres when 2 leads are implanted.
1
Neumann WJ, Staub F, Horn A, et al. Deep brain recordings using an implanted pulse generator in Parkinson’s disease. Neuromodulation. 2016;19(1):20-24.
2
Leakage requirement Doc: NDHF1513-145311. Patent: 7,83,365 (24 Aug, 2010)
3
Medtronic Manual M968090A - 0.5 mm Spaced Lead Assembly
4
Medtronic Manual M972500A - 1.5 mm Spaced Lead Assembly
5
Medtronic Internal Report NDHF1513-164903, DBS System Requirements, SR 340792, SR 340795
6
Medtronic Manual M970702A001
*
Medtronic DBS systems are MR Conditional and safe in the MR environment as long as certain conditions are met. If the conditions are not met, a significant risk is tissue lesions from component heating, especially at the lead electrodes, resulting in serious and permanent injury including coma, paralysis, or death. Refer to the MRI Guidelines for Medtronic Deep Brain Stimulation Systems for a complete list of conditions: http://professional.medtronic.com/mri
†
Leads and extensions with markers are identified with model numbers ending in M. The extension also has a marker near the proximal end (not pictured).
‡
Excluding the distal connector end, the extension body diameter is approximately 26.7% smaller than Medtronic extensions 37085 and 37086.
§
As compared to the Stimloc™ burr hole device.
||
Based on a study in an animal model, the SenSight™ directional lead system provided on average a 57% lead tip stability improvement compared to Medtronic’s legacy lead system. Animal data may not be indicative of clinical performance.
¶
When compared to the Model 37085 and 37086 extensions.
Brief Statement:
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.