|This article needs additional citations for verification. (May 2014) (Learn how and when to remove this template message)|
|Lothar Krings, Joachim Langer, Ralf Lieb|
Number of employees
Biotronik (Biotronik SE & Co. KG; Biotronik Worldwide) is a privately held multinational biomedical technology company headquartered in Berlin, Germany.
The company offers complete solutions for diagnosis, treatment, and therapy support in the areas of heart rhythm management, electrophysiology and vascular intervention. In the area of heart rhythm management, Biotronik Home Monitoring® uses telemonitoring technology to provide doctors with up-to-date information on implant patients.
Biotronik employs more than 5,600 people worldwide in over 50 countries, with research and development activities in Europe and North America. It produces all critical components of its products in-house. One in every five employees at Berlin headquarters works in R&D.
Biotronik began with the development of the first German implantable pacemaker (Biotronik IP-03) in 1963 by the physician Max Schaldach (1936-2001), a professor of biomedical technology at the Friedrich-Alexander-University of Erlangen-Nuremberg (FAU), and the 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.
In 1976, the company moved to Sieversufer 8 in Berlin-Neukölln where it still has its headquarters today. In 1979, a US production site in Lake Oswego, Oregon 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-program 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. In 1993, Biotronik began producing implantable cardioverter-defibrillators, among them the Phylax 03. 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 states, was introduced in the 1990s. In 1991, Biotronik developed fractal coating for implantable electrodes. This coating optimizes the electrically active surface of the electrode, thereby improving its perception and stimulation properties. Biotronik remains the only manufacturer of fractal-coated electrodes.
In 1994 and 1995 respectively, Biotronik began offering a full spectrum of electrophysiology products and vascular intervention products. Biotronik also develops and produces balloon catheters and stents for the treatment of coronary artery disease. With Philos, the company has offered a complete pacemaker family with telemetry since 2000, when it received CE Mark approval for the product and also successfully implanted the first pacemaker with Home Monitoring (remote patient monitoring). Home Monitoring has shown significant clinical benefits, including over a 50% reduction in mortality of heart failure patients.
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' Technical Science Prize, first awarded to Till Schlösser.
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.
In 2011, Biotronik was the subject of an investigation by the United States Department of Justice into payments made to doctors in Nevada, 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.
In 2012, the company acquired the old Postfuhramt, a historical brick postal building on Berlin’s Oranienburger Strasse in the district of Mitte. Biotronik also launched BioMonitor that year, a type of mini ECG 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 scans under certain conditions. The company offers the broadest portfolio of pacemakers and defibrillators approved to undergo MRIs.
- Heart 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
Branches and Headquarters
- Beijing, China
- Berlin-Neukölln, Germany, company headquarters with over 2,400 employees
- Baar, Switzerland
- Bülach, Switzerland, manufacturing of stents and balloon catheters
- Bicester, Great Britain
- Erlangen, Germany, Center for Technology and Service with over 130 employees
- Hørsholm, Denmark
- Kolkata, India
- Lake Oswego, Oregon, US headquarters and manufacturing facility
- Madrid, Spain
- Mapo-gu, South Korea
- Mumbai, India
- New Delhi, India
- New York City, US education and innovation center
- Nijmegen, Netherlands
- Poznań, Poland
- Prague-Nusle, Czech Republic
- Pymble, New South Wales, Australia
- Rostock-Warnemünde, Germany, Competence Center for Stent Development and Production
- Rungis, France
- São Paulo, Brazil (since 1982)
- Seoul, South Korea
- Tokyo, Japan
- Toronto, Canada
- Vienna, Austria
- Vilvoorde, Belgium
- Vimodrone, Italy
Products and Therapies
- Bradycardia therapy
- Pacemakers (Eluna, Evia, Entovis, Estella, Ecuro, Effecta)
- Electrodes (Solia, Safio S, Siello, Setrox, Selos)
- Tachycardia therapy
- Defibrillators (Inventra, Itrevia, Ilesto, Lumax VR-T DX, Lumax 7 Family, Lumax 6 Family, Lumax 5 Family, Lumax 3 Family)
- Electrodes (Linox smart, Protego)
- Ablation catheters (AlCath Flux eXtra Gold, Trignum Flux Gold, AlCath Flutter Gold, AlCath Gold, AlCath Flux,AlCath Flux Gold)
- Steerable diagnostic catheters (Lexx, ViaCath)
- Non-steerable diagnostic catheters (MultiCath, Woxx)
- Cardiac resynchronization
- CRT defibrillators (Inventra, Itrevia, Idova, Ilesto, Lumax 7 Family, Lumax 5 Family, Lumax 3 Family)
- CRT pacemakers (Eluna, Entovis, Evia,),
- Electrodes (Corox OTW, Sentus OTW UP),
- Lead systems and accessories (Selectra, ScoutPro, ScoutPro IC)
- Guidewires (Streamer, VidionWire)
- Coronary vascular intervention
- Sirolimus-eluting stent system (Orsiro)
- Balloon-expanding cobalt chromium coronary stent systems (PRO-Kinetic Energy, PK Papyrus)
- Paclitaxel-eluting balloon catheter (Pantera Lux)
- Balloon catheters (Pantera Pro, Pantera, Pantera LEO, AngioSclupt PTCA)
- Electrodes (Streamer, Cruiser, Galeo Pro)
- Magnesium-based sirolimus eluting resorbable scaffold (Magmaris)
- Introducer sheaths (Fortress, 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, AngioSculpt PTA, Elect Explorer),
- Electrodes (Cruiser-18, Cruiser, XT-14)
- Introducer sheaths (Fortress, Neptune Pad)
- Implantable cardiac monitor (BioMonitor 2, BioMonitor)
- External devices (Renamic, Recor, ICS 3000, Reliaty, Qiona ablation pump, heart stimulator UHS 3000)
- Patient devices for Home Monitoring (Cardio Messenger, CardioMessenger 2, CardioMessenger Smart)
- "BIOTRONIK SE & Co. KG". Company profiles. Hoovers. Retrieved 3 April 2011.(subscription required)
- "Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial - The Lancet". www.thelancet.com. doi:10.1016/S0140-6736(14)61176-4. Retrieved 2016-04-22.
- Meier, Barry (April 2, 2011). "Tipping the Odds for a Maker of Heart Implants". International New York Times.
- "Lake Oswego medical device firm, Biotronik, will settle federal kickback claims for $4.9 million". OregonLive.com. Retrieved 2016-04-22.
- Budnick, Nick (August 6, 2013). "Groundbreaking Oregon DOJ cases target doctors' failure to inform patients about device payments". OregonLive.com.
- "Oregon DOJ case means doctors could tell patients ties to drug, implant makers". OregonLive.com. Retrieved 2016-04-22.
- "BIOTRONIK CardioMessenger Smart Shares Pacemaker and ICD Data with Cardiologists |". Medgadget. Retrieved 2016-04-22.
- "BIOTRONIK's BioMonitor 2 Implantable Wireless ECG Recorder Approved in Europe |". Medgadget. Retrieved 2016-04-22.