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77% of ACUITY X4™ spiral leads programmed with a proximal electrode.

.9V median pacing capture thresholds for the best proximal electrode of the ACUITY X4 spiral leads.1

Automatically identify the longest RV-LV delay with LV VectorGuide.

ACUITY X4 Quadripolar LV Lead


VectorGuide


Optimise Basal Pacing

Basal pacing is shown to lead to improved patient outcomes3-6. ACUITY X4 is the only family of quadripolar leads designed to optimize basal pacing1-2.

MADIT-CRT6

“LV leads positioned in the apical region were associated with an unfavourable outcome, suggesting that this lead location should be avoided.”

VectorGuide

Quickly provides pertinent measurements of 17 vectors options based on clinically relevant tests including RVS-LVS delay and PNS. 

  • Longer RVS-LVS delay is associated with 30% reduction
    of risk of HF hospitalization or death7
  • RVS-LVS Delay test is automated and takes <1 minute

  

NAVIGATE X4 Study1

Investigational Device Exemption trial of ACUITY X4 family of leads.

  • Prospective, single-arm, non-randomized, multicenter clinical trial
  • Enrollment of 791 patients in 88 US centers
    • n = 520 (either Spiral L or S) / n = 218 (Straight lead)
  • Primary endpoint: 6-month LV lead-related complication rates, left ventricular pacing capture thresholds (LVPCT) at 3 months
  • Three lead options – thus, greater opportunity for non-apical pacing
  • LVPCT on Spiral leads were lower on proximal electrodes compared to distal electrode (0.9V vs 1.3V).
  • Physicians selected proximal electrode vector in most patients.

  

 

  • Implant success = 97%
  • Low acute and chronic complication rates
    • 99.1% dislodgement complication free rate
    • 8% phrenic nerve stimulation (PNS) observation rate
      • Proximal electrodes have lower PNS rate (5%) than distal electrode (15%)
      • 0.4% re-intervention rate for PNS

  

 

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