BIOTRONIK receives European approval for new ProMRI Pacing Systems

BIOTRONIK SE & Co. KG:

“We are very pleased to offer physicians the choice to select from a series of the most technologically advanced pacemakers — the Evia series of pacemakers — and at the same time give their patients access to MRI diagnostic procedures”

BIOTRONIK, a leading manufacturer of implantable cardiac devices and pioneer of wireless remote monitoring technologies, announced today the European approval of its new ProMRI Pacing Systems — Evia pacemaker series and Safio S pacing leads — providing European patients the first portfolio of bradycardia systems that are compatible with Magnetic Resonance Imaging (MRI) scans under specific conditions.

When it comes to pacemaker and lead selection, one system may not be optimal for every patient. Physicians consider many different parameters that are unique to each individual patient when selecting the best combination. The approval of BIOTRONIK's ProMRI series is the first time an entire pacemaker series, including two single chamber and two dual chamber devices, has been cleared for use in combination with MRI. In this way, physicians have the unique opportunity to select the optimal device from the Evia pacemaker series with the most advanced physiological therapy available and at the same time, give their patients access to MRI scanning. BIOTRONIK's ProMRI portfolio includes four different Evia pacemakers and two different lengths of the Safio S pacing leads.

The system was designed and approved for use with MRI under specific conditions. To gain approval, the new ProMRI Pacing Systems (Evia pacemakers with the Safio S leads) were vigorously tested in various combinations of device and lead positions and lengths, scanning time periods, and body positions in the MRI machines, all under strict regulation of the notified body.

"We are very pleased to offer physicians the choice to select from a series of the most technologically advanced pacemakers — the Evia series of pacemakers — and at the same time give their patients access to MRI diagnostic procedures," said Marlou Janssen, Vice President, Global Marketing and Sales, Cardiac Rhythm Management (CRM), BIOTRONIK. "BIOTRONIK is developing an entire CRM portfolio of MRI-compatible devices offering quality therapies to enhance patients' safety and expand treatment options."

MRI is the gold standard for soft tissue imaging and an invaluable medical diagnostic tool for many common diseases and conditions in the area of oncology, neurology and orthopedic injuries. In 2007, there were approximately 30 million MRI scans conducted in the United States alone and that number continues to grow. Until recently, the two million European patients with an implanted pacemaker were prohibited from receiving MRI scans, because the strong forces applied as part of the MRI scanning could negatively affect the pacemaker system or patients' safety.