SmartCRT™

ACUITY X4
VectorGuide
ACUITY X4
VectorGuide

Reach the site of latest activation. The unique ACUITY™ X4 3D spiral enables basal pacing with proven stability¹ and low Pacing Capture Thresholds. Though the site of latest activation will be non-apical for many patients, it may not be for all. VectorGuide™ includes automated RV-LV test that enables physicians to quickly determine which electrode is closest to the site of latest activation.

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ACUITY X4

VectorGuideTM

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 optimise 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. 

Rules of thumb:

  • Longer RVS-LVS delay is associated with 30% reduction
    of risk of HF hospitalisation 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-randomised, multicentre clinical trial
  • Enrolment of 791 patients in 88 US centres
    • 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
Key findings of the NAVIGATE X4 Clinical Study

NAVIGATE X4
Clinical Study results

The ACUITY™ X4 lead is designed to enable
basal pacing with proven stability

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