DBS therapy leads

SenSight™ directional lead

<p>The SenSight™ directional DBS lead system combines the benefits of directionality with the power of sensing.</p>

Indications, Safety, and WarningsThe material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s).Please note that the intended use of a product may vary depending on geographical approvals.See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI.If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com.Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.Medtronic products placed on European markets comply with EU and UK legislation (if applicable) on medical devices. For any further information, contact your local Medtronic representative.

Features

A system designed around you

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 a DBS directional lead system with 3T and 1.5T MR Conditional^† eligibility.

SenSight™ directional leads

1-3-3-1 electrode configuration to more precisely direct the stimulation
1.5 mm and 0.5 mm electrode spacing options to suit various targeting and patient needs
Completely insulated orientation markers to guide directional programming

See the SenSight Directional Lead extension image.

SenSight™ directional lead — proximal end features

Proximal end of lead inserted into extension
Laser-etched markers on the proximal end for identification of left and right leads with bilateral implants
Laser-etched insertion line on the lead body, which provides visual confirmation of complete insertion — providing confidence in the connection

SenSight™ extension

Single set screw connection on a non-active contact to minimize steps and protect therapeutic delivery
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 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

SenSight™ burr hole device: base, support, clip, and cover

Specifications

SenSight™ directional lead kit B33005 and B33015

Compatible with:

Devices	B35200 Percept™ PC B35300 Percept™ RC 37601 Activa™ PC 37612 Activa™ RC
Extensions	B34000 SenSight™ Extension Kit
Implant Tools	B31010 SenSight™ Depth Stop and Cranial Tunneler Kit B31040 SenSight™ Lead Test Cable Kit B31020 SenSight™ Lead Cap Kit
Burr Hole Device	B31000 SenSight™ Burr Hole Device B32000 SenSight™ Burr Hole Device Kit
Clinician Programmer	CT900 8880T2 Communicator A610 3.0 Software Application A610 4.0 Software Application (Required for Percept™ RC)

^{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 leads^a

Description (No Marker)	Model B33005 or B33015
Description (Bilateral Marker)	Model B33005M or B33015M
Conductor Resistance^b,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 exposed^d,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.}

Similar products

† MR Safety Triangle Under specific conditions. Refer to product labeling for full list of conditions: manuals.medtronic.com/manuals/mri/region.

‡ Excluding the distal connector end, the extension body diameter is approximately 26.7% smaller than Medtronic extensions 37085 and 37086.

§ 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).

|| As compared to the Stimloc™ burr hole device.

¶ When compared to the Model 37085 and 37086 extensions.

# 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.

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.