BIOTRONIK, a leading manufacturer of innovative medical technology, announced today the first implantations of the new Lumax 740 implantable cardiac defibrillators—the world's first and only ICDs eligible for use with magnetic resonance imaging. ProMRI®, an MR Conditional feature, combined with the product's extended device longevity and BIOTRONIK Home Monitoring®, brings the Lumax 740 series to the forefront of cardiac devices for patients with tachyarrhythmias. Furthermore, a new intracardiac impedance (ICI) assessment technology integrated into the Lumax HF-T device will be evaluated in clinical studies: this research feature aims to enhance therapy for heart failure (HF) patients in the future.
After receiving CE approval on November 18th, the first device implantations were performed at a number of hospitals in several European countries.
"BIOTRONIK's 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. 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.
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 patient's device to the physician continuously and automatically using BIOTRONIK Home Monitoring®, the industry's 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 BIOTRONIK's 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 industry's broadest portfolio of implantable cardiac devices that are eligible for use with MRI," commented Dr. Werner Braun, Managing Director of BIOTRONIK.
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