Biotronik launches new study of ProMRI technology

Biotronik has announced the initiation of a US-based study to gather new data on the performance of cardiac devices equipped with its ProMRI technology.

The US Food and Drug Administration has signed off on the new ProMRI study, which will recruit 245 subjects implanted with the company's Entovis dual and single-chamber pacemaker systems.

It will assess the performance of the devices following exposure to magnetic resonance imaging (MRI), in order to establish the effectiveness of the ProMRI technology in helping these patients undergo MRI scans without fear of interference with their pacing aids.

This is the first of several studies on this topic that Biotronik will be carrying out, with the final aim of submitting this data to regulators.

Kevin Mitchell, vice-president of clinical studies for Biotronik, said: "We look forward to ensuring that these patients have access to the procedure with the most technologically advanced pacemaker available."

Last month, the company reported data from a study that demonstrated the benefits its Home Monitoring system can provide for patients receiving implantable cardioverter defibrillator therapy.