BIOTRONIK Evia HF-T, World’s First MRI-Approved CRT Pacemaker

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BIOTRONIK Evia HF-T, World’s First MRI-Approved CRT Pacemaker

BERLIN--(Marketwire - April 27, 2012) -

BIOTRONIK, a leading manufacturer of medical devices featuring innovative technology, announced today the European market release of the new Evia HF-T pacemaker series. Evia HF-T is the first cardiac resynchronization therapy (CRT-P) device approved for use in an MRI environment(1). In addition, the Evia HF-T series offers remote patient management with BIOTRONIK Home Monitoring®, as well as detailed data available via BIOTRONIK’s Heart Failure Monitor. This information allows for faster therapy intervention to relieve even asymptomatic symptoms earlier and may even help to decrease hospitalization.

“Until now, patients with a CRT pacemaker were denied MR scanning,” remarked Prof. Valeria Calvi, MD, Director of Cardiac Pacing and Electrophysiology at University of Catania, Ferrarotto Hospital, Italy. “MR images give essential diagnostic information that impacts important therapeutic decisions and offer clear insights into the progression of the disease. Now that BIOTRONIK enables heart failure patients with the Evia HF-T device to undergo MR scans, it is reassuring that patients can benefit from these optimal diagnostic procedures when they should need them during their lifetime.”

The usage of MR scans increases with age, due to an increased prevalence of comorbidities like stroke, brain tumors and arthritis -- conditions that might require MR scans for exact diagnosis.(2,3,4) The prevalence of heart failure also increases with age. The average age of patients with heart failure is 75 years,(5) therefore it is vital that heart failure patients have access to MR scanning.

Treatment of heart failure
According to the European Society of Cardiology, heart failure affects around 30 million people in Europe and its incidence is still increasing.(6) Data from the US show that heart failure is responsible for more hospitalizations than all forms of cancer combined and that it is the most frequent cause of hospitalization in patients aged 65 years and older.(7) Rehospitalization rates during the six months following discharge are as high as 50%.(8)

“Most heart failure patients suffer from a variety of symptoms which can suddenly escalate and may need immediate attention,” commented Prof. Valeria Calvi, MD. “Each heart failure patient’s disease management is complex and requires detailed information on his or her disease status and cardiac device system performance. It is vitally important to monitor these patients closely to avoid rehospitalization. For this BIOTRONIK offers advanced solutions with its Heart Failure Monitor and its BIOTRONIK Home Monitoring® system.”

BIOTRONIK Home Monitoring® enables unique early detection of changes in patient status. The COMPAS trial(9) demonstrated that the use of BIOTRONIK Home Monitoring® enabled significantly earlier physician interventions: Up to four months were gained through early detection of clinically relevant events compared to the control group. Further, COMPAS demonstrated for the first time that BIOTRONIK Home Monitoring® delivers a 66% reduction of hospitalizations for atrial arrhythmia and related stroke. Important clinical trend data reported by BIOTRONIK’s Heart Failure Monitor enable physicians to clarify patient symptoms and underlying clinical mechanisms.

“The new Evia HF-T series completes BIOTRONIK’s technologically advanced bradycardia product portfolio. Together with its Lumax 740 tachycardia series BIOTRONIK offers the industry’s broadest portfolio of implantable cardiac devices in brady-, tachy- and CRT-therapy approved for use with MRI,” stated Christoph Böhmer, Managing Director BIOTRONIK. “We have taken a leadership position both in innovation and in offering physicians and their patients the broadest options for individualized therapy, including access to MR scanning,” added Christoph Böhmer.

Sites involved in the first implantations of the Evia HF-T pacemaker with ProMRI®
Dr. Theodoros Ballidis, Community Hospital Bonn, Germany
Prof. Valeria Calvi, MD, Ferrarotto Hospital, Italy.
Prof. Dr. Bernd Eber, Hospital Wels-Grieskirchen GmbH, Austria
Prof. Dr. Gerhard Hindricks, Heartcenter Leipzig, Germany
Dr. Istvan Szendey, Hospital Maria Hilf Mönchengladbach, Germany

About BIOTRONIK Home Monitoring®
BIOTRONIK has pioneered advances in its BIOTRONIK Home Monitoring® remote patient management system since its first clinical application in the year 2000. 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. The technology leads to earlier intervention, as proven by the results of the TRUST(10,11) landmark trial. Today, BIOTRONIK Home Monitoring® is used extensively in more than 5,300 clinics and 56 countries worldwide.

About ProMRI®
ProMRI® allows patients with a pacemaker, ICD, CRT-D or CRT-P to undergo an MR scan. The BIOTRONIK ProMRI® Evia HF-T series marks the first time a CRT pacemaker 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 Evia series -- offering their patients the most advanced therapy available, plus access to MR scans.

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) For detailed information about ProMRI® including the complete set of conditions and prerequisites please visit www.biotronik.com/promri
(2) Prevalence of Stroke by Age and Sex: NHANES 1999-2002.
(3) US Cancer Statistics (USCS) 1999-2007; Disease Control and Prevention (CDC) Website.
(4) Perruccio et al., J Rheumatol. 2006, 1856-1862.
(5) ESC Guidelines 2008, European Heart Journal (2008), 29, 2388-2442.
(6) ESC Heart Failure Congress 2008.
(7) Roger VL et al., Heart disease and stroke statistics - 2011 update: a report from the American Heart Association, Circulation, Feb 1, 2011, 123(4):e18-e209.
(8) Jencks SF, Williams MV, Coleman EA., Rehospitalizations among patients in the Medicare fee-for-service program, N Engl J Med, Apr 2, 2009, 360(14):1418-28.
(9) Mabo et al., The COMPAS Trial, European Heart Journal 2011, doi: 10.1093/eurheartj/ehr419.
(10) Varma et al., The TRUST Trial, Circulation 2010, 122, 325-332.
(11) Varma et al., The TRUST Trial, Circ Arrhythm Electrophysiol 2010, 3:428-436.