Aleva Neurotherapeutics SA
directSTIM - DBS System
The directSTIM™ DBS System is a rechargeable system with 2 x 12-electrode lead. The System can be implanted to deliver unilateral or bilateral stimulation. For optional intraoperative testing during lead placement, a trial stimulator provides stimulation by emulating the implantable stimulator. The clinician sets the stimulation with the Clinician Programmer. The patient uses the Patient Programmer Charger to control stimulation and charge the implantable stimulator.
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A directSTIM™ DBS System can be implanted in a one or two-stage procedure.
- In a one-stage implant procedure, one or two leads and extensions and the implantable stimulator are implanted in one procedure.
- In a two-stage implant procedure, one or two leads are placed and capped with connector boots during the first stage. During the second stage the connector boots are removed, then the extensions and implantable stimulator are implanted.
The implanted components deliver stimulation to the part of the brain specified in the indication.
- directSTIM™ 24-Channel Implantable Pulse Generator Model 12000 (implantable stimulator) The implantable stimulator has two 12-channel connector ports. Each channel corresponds to an electrode on a lead. The implantable stimulator is rechargeable.
- directSTIM™ 12-Electrode Lead Model 11500 The 12-electrode lead is configured with four levels of three electrodes. The lead length is 40 cm.
- directSTIM™ 12-Connector Extension Model 12100 The extension provides additional length between the lead and the implantable stimulator. The extension length is 60 cm.