This article is more than 5 years old. Information may no longer be current.
Biotronik announces FDA approval, launch of three products for patients with heart failure, arrhythmias
Click Here to Manage Email Alerts
Biotronik announced the launch of three products recently approved by the FDA: a quadripolar left ventricular lead, a technology to detect when a patient with a cardiac rhythm management device enters an MRI environment, and a pacing technology for patients with HF unresponsive to cardiac resynchronization therapy.
The quadripolar left ventricular lead (Sentus ProMRI) is the thinnest available in the United States and is approved for use with devices for patients with HF, according to a press release issued by the company.
Approval was based on the QP ExCELs study, in which the technology was associated with a 97.1% complication-free rate at 6 months, a 1.43% rate of lead dislodgement and a 93.4% rate of permanent pacing vector pacing threshold lower than 2.5 V at 6 months, according to the release.
The detection technology (MRI AutoDetect) automatically recognizes when a patient has entered the MRI environment and converts the device to MRI mode so hospital staff does not have to, according to the release. It can be programmed to be active for up to 14 days.
The pacing technology (MultiPole Pacing) will be made available on the company’s CRT defibrillator systems, according to the release.
It is designed to enable the left ventricle to pace twice during each cardiac cycle, increasing the odds that a patient with HF will respond to CRT, the company stated in the release.