FDA approves Attain Performa quadripolar lead and Viva Quad CRT-Ds


Medtronic has announced it that has received United States Food and Drug Administration (FDA) approval for the Attain Performa Model 4298 quadripolar lead, and the Viva Quad XT and Viva Quad S cardiac resynchronisation therapy defibrillators (CRT-D). The quadripolar lead and devices will be broadly available to physicians in mid-September.

With 16 pacing configurations and shorter spacing between the two centre electrodes, the Attain Performa Model 4298 left-heart lead provides additional options for physicians to treat different patient anatomies. The new quadripolar lead reduces the incidence of phrenic nerve stimulation, a potential side effect that results in muscle twitching, hiccups or shortness of breath. The Viva Quad XT device is equipped with the proprietary AdaptivCRT feature, which preserves normal heart rhythms and automatically adjusts to patients’ needs to customise therapy. The system includes VectorExpress technology, which reduces lead programming time to two minutes by providing physicians with clinically actionable information to help them select optimal pacing configurations for each patient.

Quadripolar leads help physicians optimise cardiac resynchronisation therapy delivery. The Attain Performa lead addresses the clinical challenges that can compromise lead position, offering implanting physicians more options to maintain lead position and optimise CRT therapy. The Model 4298 lead has a canted shape, and steroid on all four electrodes for lower pacing thresholds.

“Compared to conventional leads, the additional pacing configurations offered by this system provide implanting physicians more options to optimise CRT delivery, which results in better patient care. Likewise, the narrow-spaced bipole helps avoid phrenic nerve capture,” says George H Crossley, associate professor, Vanderbilt Heart and Vascular Institute, in Nashville, USA.

About the AdaptivCRT Algorithm

The AdaptivCRT algorithm is the first significant advance to improve patient response rates to CRT since the advent of the therapy more than 10 years ago. The benefits of the algorithm were demonstrated in the Adaptive CRT trial, a prospective, multicentre, randomised, double-blind clinical trial. Key findings from the original trial, sub-analyses and economic models:

  • For patients with normal AV conduction, AdaptivCRT showed an increase in CRT response rate of 12% at six months
  • Patients with AdaptivCRT demonstrated a 21% reduction in heart failure hospitalisations as compared to historical CRT trials
  • Patients with the AdaptivCRT technology demonstrated a 46% reduced risk of atrial fibrillation, and a 61% lower risk of atrial fibrillation-related problems
  • AdaptivCRT demonstrated a reduction in 30-day hospital readmissions for heart failure of 47%.