BIOTRONIK // Celebrating 50 years of excellence BIOTRONIK. Setting the pace, pioneering the future

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1 BIOTRONIK // Celebrating 50 years of excellence BIOTRONIK Setting the pace, pioneering the future

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3 Content 01 Company 02 Corporate history 03 Milestones 04 Innovations 05 Partnerships and training programs 06 BIOTRONIK services worldwide

4 Lumax 740

5 Company Dedicated to life, passionate about quality Since 1963, BIOTRONIK has been devoted to saving lives and improving the quality of life for patients and their families. Our research and development of cardiovascular medical devices exemplifies our commitment to maximum safety and top quality and has ever since we developed Germany s first pacemaker in Berlin in During the last half-century, more than two million of our devices have played a critical role in improving the health and wellbeing of patients. We have earned the trust of both physicians and patients, just as we trust in the skills and expertise of our over employees in more than 100 countries. Driven to perfection During the past five decades, we have specialized in three business areas and developed them with great consideration. To this day, we produce all critical components in-house and manufacture them exclusively in high-tech countries in Germany, Switzerland and the United States. BIOTRONIK business divisions Cardiac Rhythm Therapy pacemakers implantable defibrillators leads external monitors and programmers Electrophysiology Products for electrophysiological studies and therapies: ablation catheters diagnostic catheters Vascular Intervention Innovations for coronary and peripheral applications: stent systems balloon catheters guidewires

6 A culture defined by excellence BIOTRONIK s globally renowned drive for innovation and quality has created a deep and sustainable corporate culture that values our employees as our greatest assets. Many of our employees are involved in research and development, including one-fifth of the staff at our Berlin headquarters alone. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day. Meeting our corporate objectives demands both an extraordinary degree of dedication and a continuous commitment to learning, which is why we place particular emphasis on encouraging our employees to develop and expand their skill set. We take pride in educating specialists and managers from the fields of computer science, engineering, and natural sciences and preparing them to be one step ahead of advances in the world of cardiology. Sentus

7 We are proud of 50 years of unsurpassed quality Rachid Merzouki, Quality Assurance Leads

8 A success story that is just beginning What began in the early 1960s at the Technical University of Berlin has developed into our shared story of success. We have remained true to ourselves. We couple scientific curiosity with team spirit and visionary thinking. The result is consistent doubledigit growth rates and an increasing market presence on all five continents. We are filled with pride and gratitude at what we have achieved thus far, and knowing how far we have come gives us the energy to continue investing in what will become the technology of future generations. AlCath Gold

9 Corporate history 1963 Max Schaldach and Otto Franke develop the first German pacemaker in Berlin and found BIOTRONIK BIOTRONIK launches BIOTRONIK Home Monitoring, a milestone in telecardiology The renowned hospital, Charité, based in the eastern part of Berlin, places its first order for a BIOTRONIK pacemaker BIOTRONIK Home Monitoring earns a place in the U.S. Food and Drug Administration s (FDA) Technology Hall of Fame. A team of visionaries BIOTRONIK is one of the key drivers of innovation in medical technology and patient therapy. The intelligent sensors in our devices are already taking on vitally important functions in the prediction and prevention of cardiovascular diseases. And in the future, we will always remain a step ahead in developing new solutions. Linox smart 1979 BIOTRONIK opens a new production facility in the United States in Lake Oswego, Oregon BIOTRONIK marks its commitment to the Latin- American market by establishing its first office in Brazil BIOTRONIK develops the first German implantable defibrillator (ICD) BIOTRONIK expands its company portfolio by adding vascular intervention devices, later beginning their production in Switzerland BIOTRONIK develops its first fully computersupported electrophysiological measuring station BIOTRONIK develops its first cardiac resynchronization therapy (CRT) implants the first CRT devices in the world to allow patients to be monitored remotely BIOTRONIK pacemakers now feature innovative ProMRI technology, allowing patients to receive vital magnetic resonance (MR) scans postimplant BIOTRONIK opens its Singapore office, affirming its commitment to the Asia-Pacific region. Today With over 5600 employees in more than 100 countries, BIOTRONIK is stronger than ever continuing to expand its product portfolio and global presence every year.

10 Milestones IP-03, the first German pacemaker. IVP-44, the world s first pacemaker with active-fixation atrial leads. IDP-54-L, the first pacemaker to feature a lithium battery and titanium housing. Nomos 01, a multiprogrammable, singlechamber pacemaker with high stimulation amplitude. Neos 01, the company s first pacemaker with bidirectional telemetry. Phylax 03 / Phylax 06, the company s first ICD and the world s smallest ICD respectively. For the first time the devices feature a fractal-coated lead. Inos CLS, the first rate-adaptive pacemaker with Closed Loop Stimulation (CLS). BIOTRONIK Home Monitoring, the only FDA- and CEapproved remote monitoring system for early detection of clinically relevant events and reduction of in-office follow-ups. AlCath Gold, the first gold-tip ablation catheter, for safer, more effective ablation. Evia, an advanced pacemaker series with extended longevity and a smaller size. Lumax 540 VR-T DX, the world s first and only single-chamber ICD with complete atrial diagnostics. Pulsar-18, the world s first 4F-compatible, selfexpanding stent with lengths up to 200 mm. Orsiro, the first hybrid drug-eluting stent with a bioabsorbable polymer matrix. Lumax 740 ProMRI, the world s first ICD/CRT-D series that allows patients to undergo MR scans. BioMonitor, an implantable heart monitor for highly accurate arrhythmia detection. Ilesto 7 series, represents the second generation of ProMRI ICDs/CRT-Ds.

11 Innovations BIOTRONIK Home Monitoring We took a pioneering step in telecardiology with the development of BIOTRONIK Home Monitoring. This system enables the automatic transmission of technical device data and medical data from the patient to the physician. Our remote follow-up technology has proven to be the most reliable and convenient telemonitoring system available. ProMRI The BIOTRONIK ProMRI series represents the world s largest portfolio of cardiac devices and leads approved for MR scans. In 2012, we launched the world s first MRapproved implantable cardioverter-defibrillators and devices for the treatment of congestive heart failure; our pacemakers with ProMRI have been available since DX Atrial Sensing The Lumax DX is the world s first and only single-chamber defibrillator capable of detecting episodes of atrial fibrillation. Using just a single lead, it can accurately sense arrhythmias in the ventricle and atrium. It offers advanced therapy options and an increased degree of protection. Closed Loop Stimulation Closed Loop Stimulation (CLS), the most advanced system for regulating cardiac activity, responds not only to patients physical activity but also their mental activity. This is the only system in the world that utilizes neurological information to optimize the heartbeat during times of mental stress or heightened emotion. AlCath Flux extra Gold With its unique pure gold lead tip, this ablation catheter offers thermal conductivity up to four times greater than conventional catheters. Its innovative three-dimensional cooling profile also provides optimal distribution and efficient cooling, enabling highly effective and safe atrial fibrillation therapy. Orsiro As the industry s first hybrid drug-eluting stent, Orsiro features a passive PROBIO coating that encapsulates the stent surface, a bioabsorbable BIOlute coating to release active ingredients and is used to treat coronary artery stenosis.

12 Partnerships and training programs Alliances for advancement We believe BIOTRONIK s strong partnerships contribute significantly to our success. Together with our partners from the fields of science and research, we are constantly developing new and better forms of therapy. We make joint investments in groundbreaking clinical studies and develop training programs to ensure the best possible transfer of knowledge and development of new talent. Finding the answers of tomorrow We have one of the most substantial clinical programs in the fields of cardiac rhythm therapy and vascular intervention. Our influential studies address important, unresolved clinical questions. Studies such as TRUST and IN-TIME make a significant contribution to achieving effective, efficient and comprehensive medical care. IN-TIME

13 Combating cardiovascular disease worldwide Corporate social responsibility is a top priority at BIOTRONIK. As a global medical device company, we have dedicated ourselves to this task, and since our founding we have been particularly concerned with helping patients throughout the world obtain access to our preventive and therapeutic technologies and devices. We demonstrate this approach with our commitment to the Heartbeat International Foundation, Inc. (HBI). The mission of this global charity is to provide pacemakers and defibrillators to as many people as possible in developing countries. Together with HBI, we have already helped more than one thousand people. Arturo, from Mexico, lives with a lifesaving pacemaker thanks to Heartbeat International HeartSpan

14 BIOTRONIK services worldwide At BIOTRONIK we are committed to recognizing and understanding our customer needs by developing products that meet clinical demands and ensuring that we provide the highest level of customer service to physicians around the globe. To guarantee that our customers and patients receive perfectly manufactured, high quality devices, we manufacture all critical components in-house and in countries that are world-renowned for their technical quality. Our research and production sites are based in Germany, Switzerland and the United States and this is where we develop and produce the millions of BIOTRONIK devices and technologies that save lives worldwide. BIOTRONIK headquarters, Cardiac Rhythm Management, R&D and production, Berlin, Germany BIOTRONIK Vascular Intervention, R&D and production, Bülach, Switzerland BIOTRONIK Cardiac Rhythm Management, R&D, Lake Oswego, Oregon, USA

15 We are proud of 50 years of committed service. Ceylan Avan, Corporate Logistics & Services

16 Astron Pulsar

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18 BIOTRONIK Setting the pace, pioneering the future /E/1310 BIOTRONIK SE & Co. KG All rights reserved. Specifications are subject to modification, revision and improvement. BIOTRONIK SE & Co. KG Woermannkehre Berlin Germany Tel +49 (0) Fax +49 (0) sales@biotronik.com

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