TOKYO, Japan, July 1, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology has launched the world’s first ProMRI®
quadripolar cardiac resynchronization therapy defibrillator (CRT-D), Itrevia 7 HF-T QP, to the Japanese market. The release is part of a wider BIOTRONIK product rollout in the country in 2015.Dr. Kenji Ando from Kokura Memorial Hospital said the device will benefit patients implanted with cardiovascular implantable electronic devices (CIEDs) who have comorbidities. “Patients implanted with CIEDs can have a variety of underlying diseases such as sick sinus syndrome, complete AV block, atrial fibrillation with bradycardia, ventricular arrhythmias and/or chronic heart failure,” he commented. "So, it is important that the implanted device is compatible with MRI scans as the risk of stroke is always present.”He also cites the quadripolar left ventricular lead as “one of the most beneficial tools” in cardiac resynchronization therapy. “It has the advantage of potentially avoiding phrenic nerve stimulation and allows for ventricular basal pacing. The Itrevia 7 HF-T QP is the first device on the market to combine the benefits of both MRI scans and the quadripolar lead, which makes it a much anticipated device for improving the standard of patient care in Japan,” added Dr. Ando.BIOTRONIK ICDs and CRT-Ds with Home Monitoring lower the number of patients receiving inappropriate shocks by 52%, as proven by the ECOST clinical trial1. The devices also come with Closed Loop Stimulation (CLS), a unique physiologic rate-adaptive technology that provides optimal heart rate under varied circumstances, even during acute mental stress. An automatic atrial therapy solution is also available to detect atrial tachycardia and atrial fibrillation episodes.MRI offers very detailed images, so it is the method of choice for the diagnosis of many injuries and body conditions. Until recently patients with cardiac devices were denied MRI access due to the potential hazard the strong magnetic fields and radio waves would have on cardiac devices and leads. However, many of these patients will need an MRI scan within their lifetime2.Addressing this issue through design and scrupulous testing, BIOTRONIK developed its ProMRI technology and now boasts the world’s largest portfolio of MR conditional devices and leads. 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 people3 and Itrevia 7 will allow even more patients access to this superior diagnostic tool.The Japan release of Itrevia 7 is part of BIOTRONIK’s 2015 expanding portfolio in the country. In April, the mobile monitoring device, CardioMessenger Smart, made its global entrance in Japan following a very successful clinical study there. March saw the launch of the Iperia 7 VR-T DX: the single-chamber ICD with atrial sensing that is also MRI conditional. Since May, the Iforia 7 DR-T and VR-T, the first dual and single chamber DF4-ICDs from BIOTRONIK offering full-body, 1.5 tesla scans, is available in Japan.“As a producer of superior medical technologies, it is imperative for us to have a presence in the world’s leading technologies market,” commented Jeffrey Annis, Managing Director BIOTRONIK Japan. “It also makes sense that the world’s biggest producer of ProMRI technology should have a strong presence in the country where MRI scanning is the most common,” he added. “Our commitment to producing products that assist both physicians’ and patients’ needs has resonated with the Japanese market, as has our unwavering sense of responsibility when it comes to helping patients live normal lives.”
- Guedon-Moreau L, et al. Eur Heart J. 2013, 34 (8).
- Kalin R and Stanton MS, Pacing Clin Electrophysiol. 2005, 28 (4).
- OECD Health Statistics 2013 http://dx.doi.org/10.1787/888932917275 .