FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs / Submissions and Approvals / Research and Development / Commercial Operations

FDA Approves Phase C of Biotronik’s ProMRI Trial

March 17, 2014
A A

The FDA is allowing Biotronik to expand an observational study into its third phase to evaluate the devicemaker’s ProMRI technology in implantable cardioverter-defibrillators (ICD).

Phase A of ProMRI, which studied the safety of the company’s Entovis pacemaker in MRI scans outside the chest area, completed in November. Biotronik has since submitted a premarket application for this indication and an FDA review is pending. Phase B added cardiac and thoracic spine MRI scans to the mix; this phase is ongoing.

Phase C will evaluate the safety and efficacy of the company’s Iforia devices with Setrox and Linox Smart leads during MRI scans, excluding the chest area, in 172 patients with ICDs at 35 centers across the U.S., Biotronik says.

All devices involved in all phases of the ProMRI trial are FDA-cleared for ICD use, according to the company, but have not yet received clearance for use in MRI scans. Biotronik spokeswoman Amanda Fountain told Device Daily Bulletin that the outcome of this trial will be used to support an eventual application for FDA clearance for use with conditional MRIs.

Biotronik’s Iforia product family comprises both ICDs and cardiac resynchronization therapy defibrillators that detect and treat ventricular tachyarrhythmia and provide rate adaptive bradycardia pacing support.

According to the devicemaker, more than 300,000 people receive ICD implants and between 50 and 75 percent of those will eventually need MRI scans. “ICD patients are frequently recommended for MRI scans, but until now they have been unable to receive them,” said Theofanie Mela, the director of Massachusetts General Hospital’s Pacer and ICD Clinic, a participant in the trial. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.