Biotronik (BIOTRONIK SE & Co. KG; Biotronik Worldwide) is a

limited partnership A limited partnership (LP) is a form of partnership similar to a general partnership except that while a general partnership must have at least two general partners (GPs), a limited partnership must have at least one GP and at least one limited ...

multi-national

cardiovascular The blood circulatory system is a system of organs that includes the heart, blood vessels, and blood which is circulated throughout the entire body of a human or other vertebrate. It includes the cardiovascular system, or vascular system, tha ...

biomedical Biomedicine (also referred to as Western medicine, mainstream medicine or conventional medicine)

research and technology company, headquartered in

Berlin Berlin is Capital of Germany, the capital and largest city of Germany, both by area and List of cities in Germany by population, by population. Its more than 3.85 million inhabitants make it the European Union's List of cities in the European U ...

, Germany. The company offers equipment for diagnosis, treatment, and therapy support in the areas of

cardiac rhythm The cardiac conduction system (CCS) (also called the electrical conduction system of the heart) transmits the signals generated by the sinoatrial node – the heart's pacemaker, to cause the heart muscle to contract, and pump blood through the ...

management,

electrophysiology Electrophysiology (from Greek , ''ēlektron'', "amber" Electron#Etymology">etymology of "electron" , ''physis'', "nature, origin"; and , ''-logia'') is the branch of physiology that studies the electrical properties of biological cells and tissu ...

, and

vascular Blood vessels are the structures of the circulatory system that transport blood throughout the human body. These vessels transport blood cells, nutrients, and oxygen to the tissues of the body. They also take waste and carbon dioxide away from ...

intervention. In the area of cardiac rhythm management, Biotronik Home Monitoring uses tele-monitoring technology to provide doctors with up-to-date information for implant patients. Biotronik employs more than 9,000 people worldwide in over 100 countries, with

research and development Research and development (R&D or R+D), known in Europe as research and technological development (RTD), is the set of innovative activities undertaken by corporations or governments in developing new services or products, and improving existi ...

activities in Europe, North America, and Singapore. It produces all critical components of its products in-house. One in every five employees at its Berlin headquarters works in research and development (R&D).

History

BIOTRONIK began with the development of the first German implantable

pacemaker An artificial cardiac pacemaker (or artificial pacemaker, so as not to be confused with the natural cardiac pacemaker) or pacemaker is a medical device that generates electrical impulses delivered by electrodes to the chambers of the heart ei ...

(Biotronik IP-03) in 1963. The pacemaker was developed at the Technical University of Berlin by physicist Max Schaldach (1936–2001), a professor of biomedical technology at the Friedrich-Alexander-

University of Erlangen-Nuremberg A university () is an institution of higher (or tertiary) education and research which awards academic degrees in several academic disciplines. ''University'' is derived from the Latin phrase ''universitas magistrorum et scholarium'', which ...

(FAU), and electrical engineer Otto Franke. In the early years, the company worked to improve pacemakers' capacity and battery life, and secure the connections among electrodes, pacemakers, and the heart. Since its start, more than 19 million BIOTRONIK devices in over 100 countries have been implanted. In 1976, the company moved to Sieversufer 8 in Berlin-Neukölln. In 1979, a US production site in

Lake Oswego, Oregon Lake Oswego () is a city in the U.S. state of Oregon, primarily in Clackamas County, with small portions extending into neighboring Multnomah and Washington counties. Located about south of Portland and surrounding the Oswego Lake, the town ...

was built. This subsidiary resulted from the acquisition of the American pacemaker producer Stimulation Technology, Inc. At the same time, with the development and production of advanced hybrid circuitry and structural components for the medical technology industry, the company also began to develop circuits for pacemakers. In the 1980s, the dual-chamber stimulation method (DDD) was developed, leading to the manufacturing of a pacemaker that could read and react to spontaneous contractions of the atrium, and better respond to them of its own accord. To this end, BIOTRONIK developed the Diplos 03, a multi-programme DDD pacemaker with bilateral telemetry, which made it a European market leader and increased its presence in South America and Asia. In 1987, the firm moved its headquarters to Woermannkehre 1, next door to its previous location. In 1993, BIOTRONIK produced the first German implantable cardioverter defibrillator (ICD), among them the Phylax 06. Closed loop stimulation (CLS), which integrates the pacemaker into the body's own regulatory system, thereby allowing it to react to patients’ changing physical and emotional activity, was introduced in the 1990s. Also in 1993, BIOTRONIK developed fractal coating for implantable electrodes. This coating optimises the electrically active surface of the electrode, thereby improving its perception and stimulation properties. BIOTRONIK remains the only manufacturer of fractal-coated electrodes. Pankrác, Biotronik z Hvězdovy

In 1994 and 1995 respectively, BIOTRONIK began offering a full spectrum of

products and vascular intervention products. BIOTRONIK also develops and produces

balloon catheter A balloon catheter is a type of "soft" catheter with an inflatable "balloon" at its tip which is used during a catheterization procedure to enlarge a narrow opening or passage within the body. The deflated balloon catheter is positioned, then infl ...

s and

stents In medicine, a stent is a metal or plastic tube inserted into the lumen of an anatomic vessel or duct to keep the passageway open, and stenting is the placement of a stent. A wide variety of stents are used for different purposes, from expandab ...

for the treatment of

coronary artery disease Coronary artery disease (CAD), also called coronary heart disease (CHD), ischemic heart disease (IHD), myocardial ischemia, or simply heart disease, involves Ischemia, the reduction of blood flow to the myocardium, heart muscle due to build-up o ...

. With Philos, the company has offered a complete pacemaker family with telemetry since 2000, when it received

CE Mark On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification ...

approval for the product, and also successfully implanted the first pacemaker with Home Monitoring (

remote patient monitoring Remote patient monitoring (RPM) is a technology to enable monitoring of patients outside of conventional clinical settings, such as in the home or in a remote area, which may increase access to care and decrease healthcare delivery costs. RPM invol ...

). Home Monitoring has shown significant clinical benefits, including over a 50% reduction in mortality of heart failure patients. With the Lumax 540 VR-T DX in 2010, BIOTRONIK launched the first and only single-chamber defibrillator with comprehensive atrial diagnostics worldwide. Additionally, the company entered into an exclusive international distribution partnership with the Swiss medical technology company Endosense to distribute their ablation catheter TactiCath with optical contact force. The following year, BIOTRONIK released Orsiro to the market, the world's first hybrid drug-eluting stent with a bio-absorbable coating, adding to innovative treatment options combatting coronary artery disease. In 2011, BIOTRONIK was the subject of an investigation by the

United States Department of Justice The United States Department of Justice (DOJ), also known as the Justice Department, is a United States federal executive departments, federal executive department of the United States government tasked with the enforcement of federal law and a ...

(US DoJ) into payments made to doctors in

Nevada Nevada ( ; ) is a state in the Western region of the United States. It is bordered by Oregon to the northwest, Idaho to the northeast, California to the west, Arizona to the southeast, and Utah to the east. Nevada is the 7th-most extensive, ...

, United States, who use the company's products in their practices. The case was settled in 2014. In 2013, a similar investigation began and was settled involving payments to physicians in

Oregon Oregon () is a state in the Pacific Northwest region of the Western United States. The Columbia River delineates much of Oregon's northern boundary with Washington, while the Snake River delineates much of its eastern boundary with Idah ...

Berlin, Mitte, Oranienburger Strasse 35-36, Postfuhramt

In 2012, the company acquired the old Postfuhramt, a historical brick postal building on Berlin's Oranienburger Strasse in the sub-neighbourhood of

Spandauer Vorstadt Spandauer Vorstadt ("Spandauer suburb", formerly also called Spandauer Quarter or Spandauer Viertel) is a historic district in what is now the Mitte (locality), Mitte district of Berlin. Geography The Spandauer neighborhood is bordered in th ...

, in the district of

Mitte Mitte () is the first and most central borough of Berlin. The borough consists of six sub-entities: Mitte proper, Gesundbrunnen, Hansaviertel, Moabit, Tiergarten and Wedding. It is one of the two boroughs (the other being Friedrichshain-Kreu ...

. The following year, BIOTRONIK launched BioMonitor, a type of mini

ECG Electrocardiography is the process of producing an electrocardiogram (ECG or EKG), a recording of the heart's electrical activity. It is an electrogram of the heart which is a graph of voltage versus time of the electrical activity of the hear ...

device that offers continuous monitoring and daily remote data collection. In addition, BIOTRONIK also developed the world's first series of implantable defibrillators that enable patients, including those suffering heart failure, to undergo

MRI scan Magnetic resonance imaging (MRI) is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes inside the body. MRI scanners use strong magnetic fields, magnetic field gradients, and radio w ...

s under certain conditions. BIOTRONIK's ProMRI® technology includes systems approved for 1.5 T and 3.0 T MR scanning, as well as full-body scanning. The company offers the broadest portfolio of pacemakers, defibrillators, and therapies approved to undergo MRIs, with more than 1,000,000 ProMRI® devices and leads implanted worldwide. To navigate through this portfolio, BIOTRONIK invented two online tools in 2016 and 2017; th
ProMRI®SystemCheck
an
ProMRI®Configurator
correspondingly. For radiation protection, BIOTRONIK distributes the Zero-Gravity Radiation Protection System, which consists of a movable suspended body and head shield. The shield material has a significantly higher lead equivalency than traditional radiation apparel, thereby reducing radiation exposure by 87–100%. Indicated to treat peripheral artery disease in the lower limbs, BIOTRONIK released the Passeo-18 Lux in 2014 as the first peripheral drug-coated balloon. The year following, CardioMessenger Smart was launched, its new patient device for Home Monitoring, and BioMonitor 2, the second-generation insertable cardiac monitor. In February 2016, BIOTRONIK Inc. opened an Education and Innovation Center, a training facility and meeting location in New York City.

Awards

In 2007, BIOTRONIK was given the EuroPCR 2007 Novelty Award for its innovative absorbable metal stents (AMS) by the European Association of Percutaneous Cardiovascular Interventions (EAPCI). In 2009, it was nominated for the German Future Prize for its Home Monitoring system by the German Federal Ministry of Education and Research. In 2010, BIOTRONIK endowed the

Berlin-Brandenburg Academy of Sciences and Humanities The Berlin-Brandenburg Academy of Sciences and Humanities (german: Berlin-Brandenburgische Akademie der Wissenschaften), abbreviated BBAW, is the official academic society for the natural sciences and humanities for the German states of Berlin ...

' Technical Science Prize, first awarded to Till Schlösser. The CARDIOSTIM Innovation Award for Practice Improvement was granted to BIOTRONIK for its MRI AutoDetect.

Partnerships

BIOTRONIK partners with the EPIC Alliance, a global network of female electrophysiologists, in aims to increase collaboration and support for women in the field of electrophysiology.

Business focus

*Cardiac rhythm management: pacemakers, implantable defibrillators, electrodes, cardiac monitors, external monitoring and programming devices *Electrophysiology: products for electrophysiological examinations and therapy, including ablation and diagnostic catheters *Vascular intervention: products for coronary and peripheral functions including stent systems, balloon catheters and guide wires

Headquarters and locations

Europe & Middle East

;Germany *Berlin, Germany ** Berlin-Neukölln, company headquarters with over 2,400 employees **

Berlin-Mitte Mitte () (German for "middle" or "center") is a central locality () of Berlin in the eponymous district () of Mitte. Until 2001, it was itself an autonomous district. Mitte proper comprises the historic center of Alt-Berlin centered on the c ...

Erlangen Erlangen (; East Franconian: ''Erlang'', Bavarian: ''Erlanga'') is a Middle Franconian city in Bavaria, Germany. It is the seat of the administrative district Erlangen-Höchstadt (former administrative district Erlangen), and with 116,062 inhabi ...

, Centre for Technology and Service, with over 130 employees * Rostock-Warnemünde, Germany, Competence Centre for Stent Development and Production ;Austria *

Vienna en, Viennese , iso_code = AT-9 , registration_plate = W , postal_code_type = Postal code , postal_code = , timezone = CET , utc_offset = +1 , timezone_DST ...

;Belgium *

Vilvoorde Vilvoorde (, french: Vilvorde ; historically known as ''Filford'' in English) is a Belgian municipality in the Flemish province of Flemish Brabant. The municipality comprises the city of Vilvoorde proper with its two outlying quarters of Koningslo ...

;Czech Republic *

Prague Prague ( ; cs, Praha ; german: Prag, ; la, Praga) is the capital and largest city in the Czech Republic, and the historical capital of Bohemia. On the Vltava river, Prague is home to about 1.3 million people. The city has a temperate ...

Nusle Nusle () is a district of Prague. It became part of the city in 1922. Location Part of Nusle is in Prague 2 while most is in Prague 4. Nusle is located south of the city centre in ''Nuselské údolí'' (Nusle Valley) on the Botič brook. It ...

;Denmark *

Hørsholm Hørsholm () is an urban area on the Øresund coast approximately north of Copenhagen, Denmark. It covers most of Hørsholm Municipality and straddles the borders neighbouring Fredensborg Municipality and Rudersdal Municipality. Hørsholm pro ...

;France *

Rungis Rungis () is a commune in the southern suburbs of Paris, France, in the ''département'' of Val-de-Marne. It is best known as the location of the large wholesale food market serving the Paris metropolitan area and beyond, the '' Marché d'Int� ...

;Israel *Kohav Yair ;Italy * Vimodrone ;Netherlands *

Nijmegen Nijmegen (;; Spanish and it, Nimega. Nijmeegs: ''Nimwèège'' ) is the largest city in the Dutch province of Gelderland and tenth largest of the Netherlands as a whole, located on the Waal river close to the German border. It is about 6 ...

;Poland *

Poznań Poznań () is a city on the River Warta in west-central Poland, within the Greater Poland region. The city is an important cultural and business centre, and one of Poland's most populous regions with many regional customs such as Saint Joh ...

;Spain *

Madrid Madrid ( , ) is the capital and most populous city of Spain. The city has almost 3.4 million inhabitants and a metropolitan area population of approximately 6.7 million. It is the second-largest city in the European Union (EU), an ...

;Switzerland * Baar *

Bülach Bülach () is an historic town and a municipality in Switzerland in the canton of Zürich. It is the administrative capital of Bülach district. It is situated in the Glatt Valley (German: ''Glattal'') to the east of the small river Glatt and ...

, manufacturing of stents and balloon catheters ;United Kingdom *

Bicester Bicester ( ) is a historical market towngarden town and civil parish in the Cherwell district of northeastern Oxfordshire in Southern England that also comprises an eco town at North-East Bicester and self-build village aGraven Hill Its loc ...

, England

Asia

Hong Kong Hong Kong ( (US) or (UK); , ), officially the Hong Kong Special Administrative Region of the People's Republic of China (abbr. Hong Kong SAR or HKSAR), is a city and special administrative region of China on the eastern Pearl River Delta i ...

Beijing } Beijing ( ; ; ), alternatively romanized as Peking ( ), is the capital of the People's Republic of China. It is the center of power and development of the country. Beijing is the world's most populous national capital city, with over 21 ...

, China *

Kolkata Kolkata (, or , ; also known as Calcutta , List of renamed places in India#West Bengal, the official name until 2001) is the Capital city, capital of the Indian States and union territories of India, state of West Bengal, on the eastern ba ...

, India *

Mapo-gu Mapo District () is one of the 25 districts of Seoul, South Korea. Mapo has a population of 381,330 (2015) and has a geographic area of 23.87 km2 (9.22 sq mi), and is divided into 24 '' dong'' (administrative neighborhoods). Mapo is located in w ...

, South Korea *

Mumbai Mumbai (, ; also known as Bombay — the official name until 1995) is the capital city of the Indian state of Maharashtra and the ''de facto'' financial centre of India. According to the United Nations, as of 2018, Mumbai is the secon ...

, India *

New Delhi New Delhi (, , ''Naī Dillī'') is the Capital city, capital of India and a part of the NCT Delhi, National Capital Territory of Delhi (NCT). New Delhi is the seat of all three branches of the government of India, hosting the Rashtrapati B ...

, India *

Seoul Seoul (; ; ), officially known as the Seoul Special City, is the Capital city, capital and largest metropolis of South Korea.Before 1972, Seoul was the ''de jure'' capital of the North Korea, Democratic People's Republic of Korea (North Korea ...

, South Korea *

Singapore Singapore (), officially the Republic of Singapore, is a sovereign island country and city-state in maritime Southeast Asia. It lies about one degree of latitude () north of the equator, off the southern tip of the Malay Peninsula, borde ...

Tokyo Tokyo (; ja, 東京, , ), officially the Tokyo Metropolis ( ja, 東京都, label=none, ), is the capital and List of cities in Japan, largest city of Japan. Formerly known as Edo, its metropolitan area () is the most populous in the world, ...

, Japan

North America

, US headquarters and manufacturing facility *

New York City New York, often called New York City or NYC, is the most populous city in the United States. With a 2020 population of 8,804,190 distributed over , New York City is also the most densely populated major city in the U ...

, US education and innovation center *

Toronto Toronto ( ; or ) is the capital city of the Provinces and territories of Canada, Canadian province of Ontario. With a recorded population of 2,794,356 in 2021, it is the List of the largest municipalities in Canada by population, most pop ...

, Ontario, Canada

South America

Buenos Aires Buenos Aires ( or ; ), officially the Autonomous City of Buenos Aires ( es, link=no, Ciudad Autónoma de Buenos Aires), is the Capital city, capital and primate city of Argentina. The city is located on the western shore of the Río de la Plata ...

, Argentina *

São Paulo São Paulo (, ; Portuguese for 'Saint Paul') is the most populous city in Brazil, and is the capital of the state of São Paulo, the most populous and wealthiest Brazilian state, located in the country's Southeast Region. Listed by the Ga ...

, Brazil (since 1982)

Oceana

Pymble Pymble is a suburb on the Upper North Shore of Sydney in the state of New South Wales, Australia. Pymble is north of the Sydney Central Business District in the local government area of Ku-ring-gai Council. West Pymble is a separate ...

, New South Wales, Australia

Products and therapies

Bradycardia Bradycardia (also sinus bradycardia) is a slow resting heart rate, commonly under 60 beats per minute (BPM) as determined by an electrocardiogram. It is considered to be a normal heart rate during sleep, in young and healthy or elderly adults, ...

therapy **Pacemakers (''Edora, Evity, Enitra, Enticos, Eluna, Epyra, Etrinsa, Evia, Entovis'') **Electrodes (''Solia, Safio S, Siello, Setrox, Selos'') *

Tachycardia Tachycardia, also called tachyarrhythmia, is a heart rate that exceeds the normal resting rate. In general, a resting heart rate over 100 beats per minute is accepted as tachycardia in adults. Heart rates above the resting rate may be normal ( ...

therapy **Defibrillators (''Rivacor, Acticor, Intica NEO, Ilivia, Inventra, Iperia, Idova, Ilesto,'') **Electrodes (''Linox smart, Protego, Plexa'') *

Electrophysiology Electrophysiology (from Greek , ''ēlektron'', "amber" Electron#Etymology">etymology of "electron" , ''physis'', "nature, origin"; and , ''-logia'') is the branch of physiology that studies the electrical properties of biological cells and tissu ...

**Ablation catheters (''AlCath Flux eXtra Gold, AlCath Flutter, AlCath'') **Steerable diagnostic catheters (''GuidIQ, ViaCath'') **External devices (''Qubic RF, Qubic Stim, Qiona'') * Cardiac resynchronization **CRT defibrillators (''Ilivia, Inventra, Ipera, Idova, Ilesto,'') **CRT pacemakers (''Edora, Evity, Enitra, Enticos, Eluna, Epyra, Etrinsa, Entovis, Evia'') **Electrodes (''Corox OTW, Sentus OTW BP, Sentus OTW QP, Sentus OTW QP xx/49'') **Lead systems and accessories (''Selectra, ScoutPro, ScoutPro IC'') **Guide wires (''Streamer, VisionWire'') *Coronary vascular intervention **Bio-resorbable scaffold (Magmaris) **Drug-eluting stent system (''Orsiro'') **Balloon-expanding cobalt chromium coronary stent systems (''PRO-Kinetic Energy, PK Papyrus)'' **Drug-releasing balloon catheter (''Pantera Lux)'' **Balloon catheters (''Pantera Pro, Pantera, Pantera LEO, AngioSculpt'') **Guide wires (''Cruiser, Galeo Pro, Galeo Magnum'') **Accessories (''3Flow, Neptune Pad'') *Peripheral vascular intervention **Balloon-expanding stent systems (''Dynamic, Dynamic Renal, PRO-Kinetic Energy Explorer''), **Self-expanding stent systems (''Astron, Astron Pulsar, Pulsar-18, Pulsar-35'') **Balloon catheters ''(Passeo-18 Lux, Passeo-35, Passeo-35 HP, Passeo-14, Passeo-18''), **Guide wires (''Cruiser-18, Cruiser'') **Introducer sheaths (''Fortress'') *Insertable cardiac monitor (''BioMonitor 2, BioMonitor'') *External devices (''Renamic, Reocor, ICS 3000, Reliaty'') *Patient devices for Home Monitoring (''Cardio Messenger, CardioMessenger 2, CardioMessenger Smart'')

References

External links

www.BIOTRONIK.com
— global portal {{Authority control Medical technology companies of Germany Multinational companies headquartered in Germany Cardiac electrophysiology Implants (medicine) Manufacturing companies based in Berlin German brands Technology companies established in 1963 1963 establishments in West Germany German companies established in 1963