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Implantation

Implantation

The Optimizer IVs implantation is performed in a minimally-invasive procedure under local anesthesia. The IPG is generally implanted in the right pectoral region. Two right ventricular leads are placed for delivery of CCM signals and an atrial lead, used for sensing, is placed usually in the right atrial appendage (RAA).

Lead Placement

The preferred ventricular lead arrangement is for one RV lead to be placed in the anterior septal groove and the other in the posterior groove approximately halfway between the base and apex. If the patient has an ICD, a reasonable distance should be ensured between the CCM leads and an ICD lead.

In order to verify correct lead placement, appropriate lead impedances is externally measured after lead placement.

Insertion of the OPTIMIZER IVs IPG

The Optimizer IVs IPG is placed into a subcutaneous pocket in the right pectoral region. The recommended maximal depth of implant, for proper device interrogation and charging, is 2.5cm. The leads should form a gentle curve and not be under stress/tension. The IPG should be secured to the fascia using a non-absorbable ligature. The pocket is then closed.

During implantation of an Optimizer IVs Pulse Generator, the Company currently recommends that a Millar catheter be temporarily placed into the left ventricle in order to measure changes the peak rate of LV pressure rise (dP/dtmax) achieved with application of CCM signal therapy. The catheter is inserted into the left ventricle via standard percutaneous cannulation of a femoral artery under fluoroscopic guidance. In many cases a significant rise in dP/dtmax can be observed within minutes of initiating CCM therapy during the procedure.

Post implantation device interrogation is performed to assure proper device programming and to rule-out lead dislodgement. Thereafter, the patient receives standard post-operative care for a minimum of 24 hours prior to discharge.

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