News | April 16, 2014

First Patients Implanted with ICDs in Biotronik ProMRI Study

FDA-approved trial addresses critical need for improved patient access to gold-standard imaging

Biotronik Iforia ICD ProMRI Clinical Trail U.S.

April 16, 2014 — Biotronik announced that the first patients across the United States have received implants of the new Iforia implantable cardioverter-defibrillators (ICDs).

Implants occurred soon after Biotronik received U.S. 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 U.S. clinical study of its kind, it is a major step towards making ProMRI technology available in the U.S.

Every year, nearly 200,000 people in the United States are implanted with ICDs. [1] Recent studies estimate 50 to 75 percent of these patients will develop a clinical need for an magnetic resonance imaging (MRI) scan over the course of their lifetime. [2]

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, 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.

“This is an important expansion of diagnostic capabilities for my patients,” said 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.”

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 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 U.S. subject recruitment since March 2013.

For more information: www.biotronik.com

References:

1.Morgan Stanley, ICD Market, 1996-2009.

2.Roguin et al., Europace (2008): 10, 336-346.

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Lucas Boersma, M.D., Ph.D., FESC, St.
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