Press release

BIOTRONIK announces market release and first implantation of an innovative therapy system for primary prevention of sudden cardiac death

Berlin, September 12, 2007. After gaining the CE approval end of August BIOTRONIK announces the European market release and the first implantation of a novel therapy system for primary prevention of sudden cardiac death, the new Lumax 340 VR-T XL implantable cardioverter/defibrillator (ICD).

The new Lumax XL is a single-chamber ICD specifically designed for primary prevention of sudden cardiac death, providing extended longevity of nearly 10 years and featuring the advanced BIOTRONIK Home Monitoring technology for continuous and remote monitoring of the device and therapy status.

The first implants of the new Lumax 340 VR-T XL device were performed in parallel by Prof. Dr. Pedro Brugada at the University Hospital Brussel, Belgium, and by Dr. Robert Hofmann at the General Hospital Linz, Austria.
 


Primary prevention – Chance and challenge in one
Patients with a diminished heart function, i.e. in consequence of a myocardial infarction, have an increased risk of sudden cardiac death. Recent international clinical studies such as MADIT II and SCDHeFT have shown that the implantation of an ICD as primary prevention can significantly reduce the mortality rates of these patients compared with optimal pharmaceutical treatment alone. Thus the corresponding guidelines for management of such patients, published by the major European and North-American cardiologic societies, has been updated recently to reflect this findings.

One consequence of these new guidelines is a sudden growth in implantation rates and a rapidly expanding follow-up burden for the physicians, since complex devices like an ICD currently require a follow-up every three months to verify system integrity and the therapy status. This is also true for prophylactic ICD patients even though the device might be active for years without any action to rescue the patient at the decisive moment.

Furthermore, most patients that receive an ICD for primary prevention have a very good prognosis with an almost normal life expectancy. Hence, the service time of the ICD is of outmost importance, since a device replacement at the end of its service time requires an additional surgical procedure. Such a procedure is always associated with increased risks of complications such as infections, bleedings or damage of the ICD lead system that might result in further necessary procedures.
 


Extended device longevity – Less replacements and complications
To tackle the new challenges associated with primary prevention of sudden cardiac death, BIOTRONIK has developed a new innovative device, especially adapted to the needs of affected patients and attending physicians. An innovative hardware design and the implementation of a new high capacity battery make it possible for the BIOTRONIK Lumax 340 VR-T XL device to provide nearly 10 years service time under normal conditions.

“With the extended service time we can prolong the time period until the replacement of the device. This is very good news for patients and physicians, since we can significantly reduce costs and complications related to the surgical procedure, and at the same time we can improve the patient’s quality of life by keeping him or her out of the hospital as long as possible.”, said Dr. Hofmann after the successful implantation.
 


BIOTRONIK Home Monitoring – Freedom for patients and physicians
As a pioneer in telecardiology BIOTRONIK offers one of the most sophisticated systems for automatic, continuous and remote device monitoring, which is available over the complete portfolio of cardiac rhythm management devices: BIOTRONIK Home Monitoring.

The new Lumax XL continuously monitors the system integrity with daily measurements of crucial system parameters such as battery voltage and lead impedance. This system integrity surveillance is performed automatically without any need for interaction from either the patient or physician. Daily transmission of the system and therapy data to the Berlin based Home Monitoring Service Center (HMSC) is performed automatically at night using a special patient device called the CardioMessenger II. This mobile phone like patient unit uses the cellular phone network with quad band transmitter for data transmission no matter where in the world the patient is.

Using the transmitted data, the attended physician is automatically informed by the HMSC in the event of a critical change in the device status, or if the device has delivered therapies to rescue the patient. All corresponding device and patient data can then immediately be reviewed by the physician via a secured internet access from all over the world.
 


Reduced follow-up burden – With uncompromised patient safety
This unique and unmatched remote monitoring technology provides a sustained solution for dealing with the rapidly increasing follow-up burden for hospitals and outpatient clinics.

“In the vast majority of cases a follow-up of a prophylactic ICD patient ends with no abnormality detected. However, the patient and the physician have to spend a significant amount of time even though the device is okay and the patient is uncomplaining. With the Home Monitoring technology we can now continuously monitor the device and the therapy status getting immediately informed in case of any critical changes. This allows to expand the interval between follow-ups significantly without compromising the safety or the quality of care for these patients”, explained Prof. Brugada.

The BIOTRONIK Home Monitoring technology can improve the care of cardiac device recipients, enhance their safety and can help to optimize the allocation of health resources. This is the conclusion of the recently published AWARE analysis of more than 3 million Home Monitoring transmissions in a mixed pacemaker and ICD population of more than 11,000 patients, representing over 10,000 cumulative years of follow-up.
 


Lumax XL – A new standard of care
“With the market release of this new exciting product and the availability of the advanced Home Monitoring technology BIOTRONIK set the ground for a substantial change in management of patients with implanted cardiac rhythm management devices. BIOTRONIK is proud to offer intelligent and modern solutions, that help to realize latest clinical findings in daily practise without compromising quality of care and available health care budgets”, said Marlou Janssen, BIOTRONIK Vice President CRM Marketing and Sales.

 

About BIOTRONIK GmbH & Co. KG
As one of the leading European manufacturers of medical technology equipment, BIOTRONIK is present in all world markets. The company offers complete solutions for diagnosis, treatment and therapy support in the fields of cardiac rhythm management, electrophysiology, and vascular intervention.

 


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