FDA approves Biotronik’s quadripolar left ventricular lead

Biotronik’s Sentus ProMRI, a thin quadripolar left ventricular lead, has been approved by the U.S. Food and Drug Administration (FDA), the company announced today.

The introduction and approval of the device completes Biotronik’s second-generation ProMRI lead portfolio, which includes Solia and Plexa ProMRIs. Each device is designed to improve the quality of life for patients suffering with cardiac conditions. It is now the only MR conditional heart failure solution available in the U.S. that delivers ultra-high energy therapy on the first and every shock, according to Biotronik, which is based in Lake Oswego, Oregon.

"After more than 50 years with zero lead recalls, we continue to invest in solutions that positively impact patient lives," said Marlou Janssen, president at Biotronik, in a statement. "By equipping physicians with the most impactful cardiovascular solutions to confidently treat patients, we reinforce Biotronik's dedication to advancing innovation that matters to health systems, physicians and patients."

The Sentus ProMRI has an isodiametric design that combines co-radial wire insulation technology and polyurethane coating for maximum flexibility and reduced friction, the company said.

The FDA approved the Sentus ProMRI based on data collected during the QP ExCELs study, which was completed by Biotronik at 53 sites in the U.S. It revealed a 97.1 percent chance that the device is complication-free after six months and only a 1.43 percent chance of it dislodging.

"With the array of leads available today, every patient should be implanted with an MR conditional device," said Venkat R. Iyer, MD, an electrophysiologist at Bayview Physicians Group in Norfolk, Virginia, in a statement. "Our patients deserve nothing less than the best possible care. With MR conditional solutions, we can help ensure this continues throughout the patient care journey."