BERLIN–(BUSINESS
WIRE)–BIOTRONIK, a leading manufacturer of innovative medical
technology, announced today the first implantations of the new Lumax 740
implantable cardiac defibrillators-the worlds first and only ICDs eligible for
use with magnetic resonance imaging. ProMRI®, an MR Conditional feature,
combined with the products 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.
“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
Würzburg, 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-Jürgen Gutleben, Heart and Diabetes
Center North Rhine-Westphalia, Bad Oeynhausen, Germany
Dr. Thomas Konorza and Dr. Wilko Weißenberger, Essen University Hospital,
Germany
Prof. Dr. Herbert Nägele, Hospital Reinbek St. Adolf-Stift, Reinbek, Germany
Dr. Peter Lercher and Dr. Günther Prenner, Graz Medical University, Austria
About ProMRI®
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
References
1 Morgan Stanley, ICD market, 1996–2009.
2 Roguin et al., Europace 2008, 10, 336-346.
3 Varma et al., Circulation 2010, 122, 325–332.
4 Varma et al., Circ Arrhythm Electrophysiol 2010, 3:428–436.
