Berlin's BIOTRONIK reported the first implantations of the new Lumax 740 implantable cardiac defibrillators. The Lumax 740 series is the world's first and only ICD series eligible for use with magnetic resonance imaging, according to a company release. The company received CE Mark approval for the device Nov. 18.
The Lumax 740 series is part of BIOTRONIK's tachycardia product portfolio, which includes three ICDs, one CRT-D device and 16 leads. The devices can work up to 11 years, the company says in a release.
BIOTRONIK also points to a new intracardiac impedance assessment technology integrated into the Lumax device that will be evaluated in clinical studies. The intracardiac impedance measure could potentially be taken for optimizing cardiac resynchronization therapy and predicting worsening heart failure. The data are transmitted from the user's device to his or her physician continuously using BIOTRONIK home monitoring, a remote patient management system that is both FDA- and CE-approved.
"The ability to more accurately predict progressing heart failure would represent a major step forward for implant technology and functionality," reports professor Gunnar Klein, Clinic for Cardiology and Angiology, University Hospital Hannover, Germany, and coordinating clinical investigator of the Lumax 740 master study. "Currently there is no completely reliable way to ensure that physicians have sufficient time to intervene before patient status becomes critical and the situation results in acute hospitalization; the intracardiac impedance measurement is an innovative sensor-technology to study because it can contribute to the development of a reliable algorithm for early prediction of worsening heart failure."
- see BIOTRONIK's release