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FDA Approves BIOTRONIK Next Generation ICDs and CRT-Ds


5/10/2012 8:19:51 AM

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--BIOTRONIK, a leading manufacturer of innovative medical technology, has received FDA approval of its new Lumax 740 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds). Lumax 740 helps physicians monitor and treat their patients’ arrhythmias and heart failure under ever-changing medical conditions.

Lumax 740 is more informative to help manage a patient’s heart failure progression; more specific to help reduce the chances of patients receiving an inappropriate shock as confirmed by the ECOST1 study; and is more durable with extended longevity and an ICD lead backed by BIOTRONIK’s unsurpassed record of reliability. The Lumax series of ICDs and CRT-Ds is a strong evolutionary platform offering unique technologies, useful now and into the future as a patient’s cardiac health changes.

More information to manage heart failure progression

Increased lung fluid levels can be one indicator of heart failure progression. Lumax 740 devices contain BIOTRONIK’s TI feature, designed to measure thoracic impedance, which has been shown to inversely correlate with lung fluid. The patient’s physician can use this information as additional insight to manage critically important aspects of patient care, including drugs used to adjust fluid levels. What is important, and unavailable until now, is timely access to this vital information. With the Lumax 740 and BIOTRONIK Home Monitoring®, the patient’s information is automatically transmitted from the device on a daily basis and readily available to the physician without the need for any patient interaction. BIOTRONIK Home Monitoring® is the industry’s only remote patient management system with FDA- and CE-approval for early detection of clinically relevant events. TI is one of nine meaningful heart failure parameters transferred by BIOTRONIK Home Monitoring®, with several parameters allowing for customizable alerts settings.

More specific to reduce unnecessary shocks

Atrial arrhythmias are the main reason for inappropriate shocks. Lumax 740 devices are equipped with a highly sensitive and specific algorithm called SMART Detection®, which automatically extends to redetection to discriminate between true ventricular arrhythmias and supra-ventricular tachycardia. In contrast to competitors, BIOTRONIK’s SMART Detection® continues to fully function even after a first therapy attempt, which allows the device to provide pain-free therapies without compromising specificity. The ability to differentiate atrial from ventricular arrhythmias with high specificity reduces the risk for painful inappropriate shocks.

More durable to perform under demanding conditions

Durability is a hallmark of BIOTRONIK devices and the Lumax 740 device system is no exception. The new device platform includes more efficient circuitry that extends device longevity by up to 15 months, providing nearly a decade of service. A new platform lessens manufacturing complexity and assures consistently outstanding product quality. When combined with BIOTRONIK leads, which have demonstrated five decades of unsurpassed quality and reliability, Lumax 740 is poised to help thousands of patients for years to come.

About BIOTRONIK Home Monitoring®

BIOTRONIK Home Monitoring® is the first monitoring system with FDA and CE approvals to replace device interrogation during in-office follow-up visits and for early detection of clinically relevant events. The technology leads to earlier intervention, as proven by the results of the TRUST2,3 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 is the pioneer in remote patient management, launching the first of its kind in 2000. Today, BIOTRONIK Home Monitoring®is used extensively in more than 5,300 clinics and 56 countries worldwide.

About BIOTRONIK SE & Co. KG

As one of the world’s 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.

For more information: www.biotronik.com

References

1 Kacet S., presentation at ESC Congress 2011 in Paris, France.

2 Varma et al., Circulation 2010, 122, 325–332.

3 Varma et al., Circ Arrhythm Electrophysiol 2010, 3:428–436.

Upon publication, please provide us with a copy.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50273205&lang=en

Contacts

BIOTRONIK SE & Co. KG

Sandy Hathaway

Senior Director, Global Communications

Tel. +49 (0) 30 68905 1602

Email: sandy.hathaway@biotronik.com


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