Data Shows BIOTRONIK ProMRI Pacemakers Are Safe and Effective in Full-Body MRI Environment

LAKE OSWEGO, Oregon and SAN DIEGO, California, March 16, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced that clinical data demonstrating the safety and efficacy of its ProMRI^® pacemakers has been presented. Dr. William M. Bailey, medical director of Louisiana Heart Rhythm Specialists in Lafayette, LA, discussed these results at the American College of Cardiology’s (ACC) 64th Annual Scientific Session in San Diego.

At the ACC poster session Dr. Bailey reported that BIOTRONIK´s ProMRI pacemakers can safely be used in an MRI environment. They were shown to be free of significant threshold increases, significant decreases in amplitude and serious adverse effects one month post-MRI (magnetic resonance imaging). Two hundred and three patients enrolled in the ProMRI Phase B study underwent full-body MRI scans, including cardiac and thoracic spinal scans, without an exclusion zone.

“I am glad to present the latest in a growing body of data that supports the safety and efficacy of ProMRI pacemakers in the MRI environment,” commented Dr. Bailey. “Pacing devices approved for use with MRI scans will lead to crucial clinical benefits for patients.”

Additional data revealed at the congress show that clinically useful diagnostic image quality can be obtained when pacemaker patients undergo cardiac or thoracic spine 1.5 tesla MRI scans. Researchers analyzed the 203 MRI scans from the ProMRI Phase B study for image artifacts, defined as any features that appear in an image but are not present in the original imaged object. They found that 96.1 percent of the images had no artifact or contained an artifact which did not affect diagnostic image quality.

"We are pleased to share these study results as we move through the final phases of our ProMRI study, including pacemakers and ICDs," said Kevin Mitchell, Vice President, Clinical Studies at BIOTRONIK, Inc. “Given the popularity and clinical benefits of MRI scans, US patients want greater access to this potentially life-saving technology."

There are more than 6.5 million pacemaker patients worldwide,¹ and more than one million more are implanted each year.² Until recently, patients with a pacemaker or implantable cardioverter defibrillator (ICD) were denied access to MRI due to concerns that the strong magnetic fields and radio waves created by an MRI scanner could have a negative effect on both the implanted device and the patient. With its ProMRI technology, BIOTRONIK has developed a solution that will grant all cardiac rhythm patients access to vital MRI scans. BIOTRONIK is the only company which enables pacemaker patients with both single- and dual-chamber devices to undergo MRI scans in the US.

1. ^{Data on file.}
2. ^{Mond HG and Proclemer A. PACE. 2011, 34(8).}
3. ^{Investigational Device: Limited by US law to investigational use.}