BIOTRONIK Brings Only ProMRI Implantable Defibrillator Accepted for Ultra-High Field Imaging to World’s Largest MRI Market

TOKYO, Japan, April 30, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology that offers the world’s largest portfolio of ProMRI^® cardiac implants, has announced the Japanese market release of its Iperia 7 VR-T DX ProMRI single-chamber implantable cardiac defibrillator (ICD). With its DX technology, BIOTRONIK offers the world’s only ICDs that collects full atrial diagnostic information with just one lead. It is also the first company to grant patient access to both ultra-high field 3.0 tesla (T), with an exclusion zone, and full-body magnetic resonance imaging (MRI) at standard 1.5 T scan strength.

This comprehensive device offers a string of benefits over alternatives. Atrial diagnostic capabilities with a single lead mean there is less likelihood of complications bought about by additional hardware. At the same time, allowing patients to undergo 3.0 T MRI scans can be critical in diagnosing conditions such as stroke, brain tumors or orthopedic conditions. Japan is the world’s largest MRI market with more MRI scanners per capita than any other country: approximately 47 registered machines per one million people¹.

“Approximately 60 percent of our MR conditional device patients undergo MRI examinations in order to identify potential complications,” commented Dr. Toshiaki Sato from Kyorin University Hospital, Tokyo, Japan, who was one of the first to implant the Iperia DX device in a patient in Japan. “80 percent of these scans are brain MRIs. The 3.0 T MRI machine, with improved signal-to-noise ratio, was introduced in our hospital in 2010 and has been used mainly for brain MRI scans. In Japan, 3.0 T compatibility is preferred for MR conditional devices and the need for this technology will be further increased in the future.”

With Iperia, inappropriate shocks may be reduced with MorphMatch morphology detection criteria and optimized anti-tachycardia pacing. This makes it easier to give a patient the appropriate level of pacing therapy he or she might need. The device also features BIOTRONIK Home Monitoring^®, which allows physicians to remotely follow their patients’ device status on a daily basis. The system has demonstrated the ability to detect clinically relevant events, including silent, asymptomatic arrhythmias² and device related issues³ allowing for earlier intervention.

“The DX technology used in Iperia is based on more than a decade of engineering refinement to ensure accurate and reliable sensing of the atrial signal,” added Wolf Ruhnke, Vice President at BIOTRONIK. “Integrating this with our unique Home Monitoring System for early detection, and adding the capability of high resolution 3.0 T MRI procedures, now offers patients most complete care and gives physicians the best possible treatment option.”

1. ^{OECD Health Statistics 2013 http://dx.doi.org/10.1787/888932917275.}
2. ^{Varma et al., TRUST Trial. (2010), 325-332.}
3. ^{Varma et al., Arrhythmia and Electrophysiology (2010) 3:428-436.}