After receiving CE approval on November 18th, the first device implantations were performed at a number of hospitals in several European countries.
"BIOTRONIKs ProMRI® innovation in the Lumax 740 series is an important breakthrough for patients needing ICDs," said Professor Massimo Santini, Director of the Cardiovascular Department of San Filippo Neri Hospital, Rome, and President of World Society of Arrhythmias. "Until now, patients with an ICD had been excluded from undergoing MR scans despite the fact that these scans are critical for the diagnosis and therapy of patients with serious medical conditions, such as cancer, stroke and other neurologic and orthopedic conditions."
Santini continued, "The ability to use MR scans is extremely important and will become even more important in the future. MR scans deliver superior imaging quality and do not require any exposure to radiation. Hence, the Lumax 740 is really a device for the future."
Worldwide, the population of patients who need an ICD is growing at a rate of about 10–15 percent annually. At the same time, the need for MR scans is also increasing at a rate of about 10 percent each year. Approximately 30 million scans were performed in 2006, and in 2010, there were already about 50 million MR scans conducted worldwide.1 The soaring rates of patients needing ICDs and the increasing need for MR scans result in an estimated 50–75 percent probability that an ICD patient would be indicated for an MR scan over the lifetime of his or her implanted device.²
The new Lumax 740 series is part of BIOTRONIK´s technologically advanced tachycardia product portfolio, which includes three ICDs, one CRT-D device and 16 leads. The Linoxsmart ICD leads have been proven over time to be of the highest quality and reliability, and are now further enhanced with ProMRI® compatibility. Besides featuring ProMRI® technology, the devices also stand out in the industry by providing longevities of up to 11 years.
Additionally, the intracardiac impedance measure is being used to investigate changes in left ventricular volume as a parameter that could potentially be taken for optimizing cardiac resynchronization therapy (CRT) and predicting worsening heart failure. This data is transmitted from the patients device to the physician continuously and automatically using BIOTRONIK Home Monitoring®, the industrys only remote patient management system FDA- and CE-approved for the early detection of clinically relevant events.
"The ability to more accurately predict progressing heart failure would represent a major step forward for implant technology and functionality," reports Professor Gunnar Klein, Clinic for Cardiology and Angiology, University Hospital Hannover, Germany and Coordinating Clinical Investigator of the Lumax 740 Master Study. "Currently there is no completely reliable way to ensure that physicians have sufficient time to intervene before patient status becomes critical and the situation results in acute hospitalization; the intracardiac impedance measurement is an innovative sensor-technology to study because it can contribute to the development of a reliable algorithm for early prediction of worsening heart failure."
"Now that the Lumax 740 ICD series has been added to BIOTRONIKs growing portfolio of ProMRI® devices, which also includes our Evia and Estella pacemaker series and, as off today, the only MR Conditional ICDs available, we have taken a number one leadership position in innovation-with the industrys broadest portfolio of implantable cardiac devices that are eligible for use with MRI," commented Dr. Werner Braun, Managing Director of BIOTRONIK.
Sites involved in the first implantations of the Lumax 740 series
Prof. Dr. Massimo Santini, San Filippo Neri Hospital, Rome, Italy
Prof. Dr. Gunnar Klein and Dr. Hanno Oswald, University Hospital Hannover, Germany
Prof. Dr. Wolfgang Bauer and Dr. Sun-Oliver Thees, University Hospital WÃ¼rzburg, Germany
PD Dr. Christian Butter, Brandenburg Heart Center, Bernau, Germany
Prof. Dr. Wilhelm Haverkamp, Charité - University Hospital Berlin, Virchow-Clinic Campus, Germany
Prof. Dr. Dieter Horstkotte and Dr. Klaus-JÃ¼rgen Gutleben, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany
Dr. Thomas Konorza and Dr. Wilko WeiÃŸenberger, Essen University Hospital, Germany
Prof. Dr. Herbert NÃ¤gele, Hospital Reinbek St. Adolf-Stift, Reinbek, Germany
Dr. Peter Lercher and Dr. GÃ¼nther Prenner, Graz Medical University, Austria
At BIOTRONIK, we have pioneered some of the industrys most important solutions for increasing therapy effectiveness, streamlining clinic workflow and improving the quality of life for patients. One of these is ProMRI®, which allows patients to undergo an MRI scan under certain conditions, even though they have a cardiac implant. The BIOTRONIK ProMRI® tachycardia series marks the first time an ICD portfolio has been designed, tested and approved to make MR scans possible. As a result, physicians have the unique opportunity to select the optimal device from the Lumax 740 series-offering their patients the most advanced therapy available along with access to MRI scanning.
About BIOTRONIK Home Monitoring®
BIOTRONIK Home Monitoring® is the first and only remote patient management system with FDA and CE approvals for safe reduction of in-office follow-ups and for early detection of clinically relevant events. The technology leads to earlier intervention, as proven by the results of the TRUST3-4 landmark trial. The system is unique because it allows continuous, automatic wireless remote monitoring of patient status and device status with daily updates-all independent of any patient interaction. BIOTRONIK has pioneered advances in its BIOTRONIK Home Monitoring® remote patient management system since its first clinical application in the year 2000. Today, BIOTRONIK Home Monitoring® is used extensively in more than 3,800 clinics and 55 countries worldwide.
About BIOTRONIK SE & Co. KG
As one of the worlds leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 5,600 employees. Known for having its fingers 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 and treatment to patient management. Quality, innovation and clinical excellence define BIOTRONIK and its growing success-and deliver confidence and peace of mind to physicians and their patients worldwide. More information: www.biotronik.com
1 Morgan Stanley, ICD market, 1996–2009.
2 Roguin et al., Europace 2008, 10, 336-346.