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.
At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular and endovascular solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.