US FDA approves Biotronik’s Sentus ProMRI quadripolar left ventricular lead

Biotronik Sentus ProMRI

The US Food and Drug Administration (FDA) has approved Biotronik’s Sentus ProMRI, the thinnest quadripolar left ventricular lead available in the country.

Sentus ProMRI is approved for use with heart failure devices based on data collected during the QP ExCELs study. The study, which included 53 US sites, demonstrated Sentus ProMRI QP’s best-in-class performance. Key data points include:

  • 97.1% complication-free rate at six months
  • 1.43% lead dislodgement rate
  • 93.4% of subjects achieved permanent pacing vector pacing threshold lower than 2.5v at three months

Sentus ProMRI is a quadripolar coronary sinus left ventricular (LV) lead with an isodiametric design combining co-radial wire insulation technology and a polyurethane coating. This is designed for maximum flexibility and reduced friction. The lead’s four electrodes feature the company’s fractal iridium coating to maximise performance.

“With the array of leads available today, every patient should be implanted with an MR conditional device,” says Venkat R Iyer, electrophysiologist at Bayview Physicians Group in Norfolk, USA. “With magnetic resonance (MR) conditional solutions, we can help ensure this continues throughout the patient care journey.”

Sentus ProMRI is intended for use with the company’s Inventra HF-T QP cardiac resynchronisation therapy defibrillator (CRT-D), making it the only MR conditional heart failure solution available in the USA that can deliver ultra-high energy (42J) therapy on the first and every shock. This system offers Closed Loop Stimulation (CLS)—Biotronik’s physiologic rate-adaptive algorithm designed to automatically optimise to each patient’s needs based on real-time metabolic demand. It also features the company’s Home Monitoring feature, which demonstrated a 50% reduction in mortality in patients with heart failure in the IN-TIME study.