German-based firm Biotronik’s US division has commercially launched its MR conditional quadripolar (QP) cardiac resynchronisation therapy pacemaker (CRT-P), Edora HF-T QP, following approval from the US Food and Drug Administration (FDA).
Featuring MRI AutoDetect technology, 15cc volume, and longevity of approximately ten years, Edora HF-T QP is intended to minimise device replacement frequency for heart failure patients.
The MRI AutoDetect technology has been developed to enhance patient safety by decreasing the time in which the device is in MRI mode.
Once activated by a clinician, the technology automatically identifies an MRI field and changes the device programming to MRI mode.
Biotronik president Marlou Janssen said: “With the launch of Edora HF-T QP, Biotronik offers a full suite of ProMRI products, ensuring physicians can always choose MRI conditional devices for their patients.
“Our devices are the only FDA-approved CRM solutions that provide automatic detection of an MRI environment, physiologic rate adaptation, and automatic daily remote monitoring.”
The pacemaker also includes closed loop stimulation (CLS) and Biotronik Home Monitoring, which is a cardiac device remote monitoring system that comes with automatic, daily transmission verification.
The system features a summary of nine long-term heart failure statistics called Heart Failure Monitor that, in combination with daily updates, enables continuous monitoring and assessment of heart failure status.
According to previous studies, the system is linked to 50% decrease in mortality by heart failure and 36% decrease in hospitalisation for worsening heart failure.
Image: Biotronik Edora 8 HF-T QP. Photo: courtesy of Biotronik.