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.1 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.
Evia single and dual chamber pacemakers with ProMRI The Evia pacemaker series combines MRI compatibility with unique innovations for advanced patient management, from the point of implant through follow-up. The small-sized pacemakers with extended longevity also provide several automatic functions to ensure a safe and convenient implantation procedure. In addition to the new platform features, Evia builds on established and proven innovations such as Closed Loop Stimulation® (CLS), which is the only rate regulation algorithm that provides appropriate heart rate response during periods of emotional stress, for improved hemodynamics and enhanced quality of life.
To meet individual patients’ needs, Evia also provides two algorithms, Vp Suppression® and IRSplus®, which minimize unnecessary ventricular pacing, in order to lower patients’ risk of developing atrial fibrillation and heart failure.
With a thin lead body (6.6 F), Safio S are active fixation leads with a flexible distal end, fractal coating and steroid elution to ensure optimal electrical performance and a stable fixation.
Continuous remote patient monitoring before and after MRI scanning BIOTRONIK Home Monitoring® allows physicians to remotely monitor their Evia patients’ clinical and device status at any time, from anywhere in the world. Importantly, physicians are alerted if there are any clinically relevant changes in their Evia patients’ condition or pacemaker status before or after the MRI procedure and have immediate access to all relevant data. In this way, physicians are able to make appropriate treatment decisions in a timely manner. BIOTRONIK Home Monitoring® is the only remote patient monitoring system on the market today that has FDA and CE approvals to safely replace conventional in-office device follow-ups and provide early detection of symptomatic and even asymptomatic clinical events.
About BIOTRONIK As one of the world's leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 5,100 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.
1 IMV, "Benchmark Report: MRI 2007,” IMV Medical Information Division 2008.
Contact:
BIOTRONIK SE & Co. KG Sandy Hathaway, +49 (0) 30 68905 1602 Senior Director, Corporate Communications sandy.hathaway@biotronik.com
