BIOTRONIK Receives FDA Approval for Sentus ProMRI Quadripolar Left Ventricular Lead
Sentus ProMRI QP Lead with MR Conditional CRT-D Ensures Heart Failure Patients Have Access to MRI Scans
BIOTRONIK today announced FDA approval and the launch of Sentus ProMRI®, the thinnest quadripolar left ventricular lead available in the United States. This introduction completes BIOTRONIK’s second-generation ProMRI lead portfolio, which also includes Solia ProMRI and Plexa ProMRI.
Sentus ProMRI is approved for use with heart failure devices based on data collected during the QP ExCELs study. The study, which included 53 sites in the United States, demonstrated Sentus ProMRI QP’s best in class performance. Key data points include:
1 Hindricks G, et al. The Lancet. 2014, 384 (9943).
2 Not currently available in the United States.
3 CAUTION – Investigational device. Limited by United States law to investigational use.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.