FDA-approved Vercise Genus DBS family with 8-contact and 16-contact directional leads and Multiple Independent Current Control. Values rest on the FDA overview and company pages; the SSED was not read.
Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.
Boston Scientific Vercise Genus DBS
The Vercise Genus DBS System is Boston Scientific’s current DBS platform under PMA P150031. This sheet is scoped to the February 29, 2024 supplement S064, with lead and IPG details taken from Boston Scientific pages and labeled as manufacturer statements.
Identity
Field
Value and source scope
Device
Boston Scientific Vercise Genus DBS System, with Vercise PC and Vercise Gevia in the same approval, and Vercise Cartesia directional leads [1][2]
Manufacturer
Boston Scientific Corporation, Valencia, California [1]
Interface class
Implanted pulse generator (rechargeable or non-rechargeable) with 8-contact or 16-contact deep brain leads [1][2][3]
Origin
Commercial FDA-approved device within PMA P150031 [1]
First demonstrated
Unreported
First human implant
Unreported
Species studied
Unreported
Regulatory status
PMA P150031/S064 approval February 29, 2024, adding bilateral VIM stimulation for essential tremor [1]
Function
Delivers deep brain stimulation to reduce tremor in the upper arms and hands in essential tremor, among other approved indications [1]
Target tissue
Ventral intermediate nucleus (VIM) of the thalamus for essential tremor in this supplement [1]
Geometry and architecture
Field
Value and source scope
Interface type
Standard 8-contact leads (DB-2201, 30 and 45 cm) and Vercise Cartesia 8-contact directional leads (DB-2202, 30 and 45 cm); Cartesia X and HX are 16-contact directional leads [2][3]
Array layout
Unreported
Electrode count
8 contacts (DB-2201, DB-2202) or 16 contacts (Cartesia X and HX) [2][3]
Pitch
Unreported
Electrode lengths
30 cm or 45 cm for the DB-2201 and DB-2202 leads [2]
Shank width and thickness
Unreported
Tip and exposed site geometry
Unreported
Contact coating
Unreported
Insulation
Unreported
Insertion method
Unreported
Anchoring and fixation
Unreported
Electrode and channel physics
Field
Value and source scope
Exposed site area
Unreported
Electrode material
Unreported
Impedance (with measurement frequency)
Unreported
Noise floor or SNR
Unreported
Recording modality
Unreported
Sampling rate
Unreported
Stimulation capability
Multiple Independent Current Control (MICC); Cartesia 3D combines MICC with the directional lead to shape and steer stimulation; semi-bipolar and anodic stimulation modes are described [3][4]
Charge injection limit
Unreported
Reference and ground
Unreported
Tissue interface and bioresponse
Field
Value and source scope
Target tissue
Unreported
Insertion trauma and BBB disruption
Unreported
Vascular disruption risk
Unreported
Micromotion sensitivity
Unreported
Gliosis and encapsulation
Unreported
Neuron loss near sites
Unreported
Foreign-body response mitigation
Unreported
Typical failure modes
Unreported
System architecture
Field
Value and source scope
Onboard electronics
Five Genus IPGs: P8, P16, P32 (non-rechargeable) and R16, R32 (rechargeable) [5]
Data path
Clinician programmer on a tablet and a patient controller [1]
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Rechargeable options provide 30 days of stimulation between recharges (manufacturer claim); the P8 is described as the only directional single-channel primary cell [3][5]
Thermal management
Unreported
Packaging and hermeticity
Unreported
MRI compatibility
Genus, Genus Mixed with M8 or S8 adapters, Gevia and lead-only systems provide full-body MRI access when specific components and conditions are used [5][2]
Surgical complexity
Lead kit and extension kit with an IPG; mixed systems can connect to existing Medtronic or Abbott leads through adapters [1][5]
Output connectors
Unreported
Performance envelope
Field
Value and source scope
Acute yield
Unreported
Chronic yield
Unreported
Stability over time
Unreported
Longevity
Boston Scientific cites over 25,000 patients implanted worldwide and 10 years of battery performance (manufacturer statement) [5]
Revision and explant experience
Unreported
Adverse events
Unreported
Notable demonstrations
Unreported
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
Unreported
Preclinical cohort
Unreported
Follow-up duration
Unreported
Indications
Essential tremor not adequately controlled by medication, now including two-sided VIM stimulation (S064) [1]
Trials and registries
Unreported in the pages read; the FDA overview points to an SSED not fetched for this sheet [1]
Primary outcomes
Unreported
Key limitations
Values rest on an FDA overview and company pages. The SSED, clinical study sizes and adverse event rates were not read [1][3][5]
Engineering tradeoffs
Field
Value and source scope
Strengths
16-contact directional leads, which Boston Scientific states are the first and only FDA-approved of their kind (manufacturer claim) [3]
Limitations
Unreported
Scaling constraints
Unreported
Version boundary
S064 covers Vercise PC, Gevia and Genus. The 16-contact Cartesia X and HX lead claims come from Boston Scientific’s product page and are not tied to an FDA document read here.