The latest phase of the ProMRI® clinical study aims to determine whether ICD patients can safely undergo MRI scans with an exclusion zone. The study will recruit and evaluate 172 patients at 35 U.S. investigational centers. The ICD ProMRI® with exclusion zone study is designed to confirm the safety and efficacy of BIOTRONIK's Iforia devices, with Setrox and Linoxsmart leads during an MRI scan. All the devices in the study are currently commercially available, but still await FDA approval for use in the MRI environment.
The Iforia platform is BIOTRONIK's latest generation of ICDs offering uncompromised longevity and daily monitoring through BIOTRONIK Home Monitoring®. The BIOTRONIK-sponsored trial (NCT01761162) has been in U.S. subject recruitment since March 2013.
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About BIOTRONIK
As 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 200 mm 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.
Erika Kuzmicz
erika.kuzmicz@mslgroup.com
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