Biotronik has announced that the first patients across the US have received implants of the new Iforia implantable cardioverter-defibrillators (ICDs).
Implants occurred soon after Biotronik received the US Food and Drug Administration (FDA) approval for the new phase of its ongoing ProMRI trial.
Phase C will investigate the safety of ICDs in the MRI environment. The first US clinical study of its kind, it is a major step towards making ProMRI technology available in the U.S.
Medical centers participating in the ProMRI trial expressed immediate demand for the new ICD series. Iforia is Biotronik’s latest generation of ICDs, offering uncompromised longevity and daily monitoring through Biotronik Home Monitoring.
From the West, an Iforia system was implanted in Rancho Mirage, California, by Dr Leon A. Feldman, electrophysiologist at Desert Cardiology.
Farthest East in the US, a patient was implanted with an Iforia system by Dr Mark Marieb, Associate Professor of Medicine (Cardiology), Associate Clinical Professor of Nursing, and the Clinical Director of Electrophysiology at Yale School of Medicine in New Haven.
Additional implants occurred in Langhorne; Winston-Salem, N.C.; Ann Arbor, Mich.; Richmond, Va.; New York, N.Y.; and Salem, Ore.
The expansion phase of the ProMRI clinical study to include ICDs will recruit and evaluate 172 patients at 35 US investigational centers. This phase of the ProMRI study is specifically designed to confirm the safety and efficacy of Biotronik’s Iforia devices and Setrox and Linoxsmart leads during MRI scans with an exclusion zone.
All of the devices in the study are currently commercially available, but await FDA approval for use during MRIs. The Biotronik-sponsored trial (NCT01761162) has been in US subject recruitment since March 2013.
Biotronik clinical studies vice president Kevin Mitchell noted initial demand for participation in Phase C of the study has been robust, and the company is off to a great start.
"We are working closely with each of the sites to conduct the trial efficiently and effectively. Cardiac device patients and physicians express a clear need to access MRI scans. We expect this trial to take us one step closer to making that a reality," Mitchell added.