Frequent visitor to our pages, cardiovascular device company Biotronik has announced that the first patients across the United States have received implants of the new Iforia implantable cardioverter-defibrillators (ICDs).
Last month (March, 2014) we covered the news that Biotronik had gained the U.S. FDA’s nod to progress to phase C of the ongoing ProMRI® trial using its Iforia device. Phase C will investigate the safety of ICDs in the MRI environment and will be the first U.S. clinical study of its kind, which in turn makes it a major step towards making ProMRI® technology available in the U.S.
Following the FDA’s thumbs up, Medical centers already participating in the ProMRI® trial reportedly expressed immediate demand for the new ICD series, Biotronik’s latest generation of ICD which, it says, offers uncompromised longevity and daily monitoring through Biotronik Home Monitoring®.
Implants have already taken place across the U.S., including one in Rancho Mirage, Calif., by Leon A. Feldman, M.D., electrophysiologist at Desert Cardiology. Farthest East in the U.S., a patient was implanted with an Iforia system by Mark Marieb, M.D., Associate Professor of Medicine (Cardiology), Associate Clinical Professor of Nursing, and the Clinical Director of Electrophysiology at Yale School of Medicine in New Haven, Conn. Additional implants occurred in Langhorne, Pa.; 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 U.S. investigational centers. This phase of the ProMRI® study is specifically designed to confirm the safety and efficacy of the 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.
“This is an important expansion of diagnostic capabilities for my patients,” said Dr. Feldman. “MRIs offer some of the best diagnostic information for a variety of conditions, and patients with ICDs have been unable to get them. This clinical trial will verify the safety of this ICD device family and allow us to provide state-of-the-art treatment for all of our cardiology patients.”
“Initial demand for participation in Phase C of the study has been robust, and we are off to a great start,” said Kevin Mitchell, Vice President, Clinical Studies at Biotronik, Inc. “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.”
Source: Biotronik, Inc., Business Wire