Clinical Trial Leads to Implant of MRI-Compatible Defibrillator at LGMC

5/7/2014

Lafayette General Medical Center (LGMC) became the first hospital in Louisiana, as part of a clinical trial, to facilitate a new implantable cardioverter defibrillator (ICD) for testing in a magnetic resonance imaging (MRI) environment. This is the first-ever U.S. study approved by the Federal Drug Administration (FDA) for investigational use of an ICD in an MRI environment.

Each year, thousands of patients receive ICD’s, which protect them from fatal heart rhythms. Until now, these patients, once they receive the implantable life-saving device, were not permitted to receive an MRI scan due to the risk the scanner may interfere with the function of the ICD. This is a challenge for patients and physicians, as an estimated 50 to 75 percent of patients with ICD’s will need an MRI during their lifetime.

“This implant marks an important first step in better addressing the critical need for improved imaging capabilities for heart rhythm patients,” said William Bailey, M.D., the local cardiologist who performed the procedure at LGMC’s Catheterization Lab on April 21. “A large and growing number of our ICD patients require further diagnostics and, until now, could not receive them. This trial will provide much needed information toward expanding diagnostic capabilities for patients.”

The Iforia ICD is the first in the industry to be in clinical studies for MRI-conditional labeling in the United States. This makes the procedure at LGMC among the first in the country. Now in the final phase of the ProMRI® trial, sponsored by BIOTRONIK, Inc., the study is specifically designed to confirm the safety and efficacy of the Iforia device. This study is recruiting and evaluating 172 patients at 35 leading investigational centers across the U.S.

LGMC is one of the centers being used to evaluate Iforia ProMRI® systems with Setrox and Linoxsmart leads during an MRI scan. All ICD systems in the study are currently commercially available, but await FDA approval specifically for use in the MRI environment.

BIOTRONIK’s ProMRI® systems increase the potential to improve patient access to MRI scanning for patients who require pacemaker or ICD devices and give physicians more options to choose from without any therapeutic compromise. The Iforia ICD system, which is BIOTRONIK’s latest generation of small-sized ICDs being evaluated for ProMRI® technology, offers sophisticated shock-resistant capabilities, uncompromised longevity and daily monitoring through BIOTRONIK Home Monitoring®.

For more information on other clinical trials available at Lafayette General Medical Center, call (337) 289-8658 or visit LafayetteGeneral.com/ClinicalTrials

NOTE: ProMRI® is an investigational device and limited by federal law to investigational use only.

About BIOTRONIK
One of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®; the world’s first 4 F-compatible 200mm peripheral stent; Orsiro, the industry’s first hybrid drug-eluting stent; and the world’s first implantable cardioverter-defibrillators and heart failure therapy devices with ProMRI® technology. For more information, visit Biotronik.com.

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