Press release

BIOTRONIK Announces Japanese Market Approval of the Lumax 340 HF-T, Cardiac Resynchronisation device.

Tokyo and Berlin – 3 September 2008 – BIOTRONIK today announced the Japanese market approval and first implantation of the new Lumax 340 HF-T implantable cardioverter-defibrillator, a state-of-the-art device equipped with automatic Home Monitoring for enhanced patient care.  

The release of the Lumax 340 HF-T marks an important milestone for BIOTRONIK, which now offers the most technologically advanced suite of products on the market in Japan. This is further reinforced by the recent market approval of the Lumax 340 ICD family and Linox series of tachycardia leads.  

“BIOTRONIK is committed to the ongoing improvement and management of patients with symptoms of congestive heart failure and at risk of sudden cardiac death” said Marlou Janssen, Global Vice-President of Cardiac Rhythm Management, Marketing and Sales for BIOTRONIK. “BIOTRONIK is proud to bring this life-saving therapy to the Japanese market which again underlines our commitment towards technological innovation, providing the best possible solutions for effective therapy management and improving the quality of life of patients around the world”.   

The new Lumax 340 HF-T system combines the benefits of cardiac resynchronisation and life-saving defibrillation therapy for the treatment of congestive heart failure and rescue from sudden cardiac death.  Each of the devices within the Lumax 340 family including the resynchronisation device and cardioverter-defibrillator offer an innovative set of features which includes full capabilities for automatic and remote monitoring with BIOTRONIK Home Monitoring.

 

Improved Quality Of Life
Globally each year more than 20 million new patients are diagnosed with heart failure, a debilitating syndrome characterized by the heart’s inability to pump blood efficiently. This severely restricts the functional capacity of the patient and results in the common symptoms of shortness of breath and exercise intolerance. Currently, heart failure is most often treated with drug therapy, which can help manage patient’s symptoms.

A subset of heart failure patients have mechanical dyssynchrony, a condition in which the heart does not pump as a unified whole. CRT devices are implanted in these patients to help restore an efficient contraction pattern of the heart muscle, providing these patients with symptomatic relief and an improved prognosis. Two large randomized clinical trials (COMPANION, CARE-HF) have provided clinical evidence that CRT significantly improves survival in certain heart failure patients.

 

Effective and Reliable Defibrillation
Implantable cardioverter-defibrillators (ICD’s) provide protection against disturbances of the electrical rhythm of the heart, which drastically reduce the blood flow, often resulting in sudden cardiac death (SCD) within minutes. The ICD acts by delivering a high-energy electrical impulse to the heart which resets the electrical activity in the heart, so that it can start to beat regularly again. Each year more than 40,000 people in Japan die from SCD which, could potentially be avoided through the implantation of an ICD.   
 


About BIOTRONIK GmbH & Co. KG

As one of the worlds leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is present in all world markets. Known for having its finger on the pulse of the medical community, BIOTRONIK helps to assess the challenges physicians face, and provides the best solutions, be they cardiac implants, minimal invasive devices or other products and services ranging from diagnosis to electrotherapy and vascular intervention or therapy management. Quality, innovation, and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.

 


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