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entailed treating cardiologists to lavish dinners, winery tours, baseball games, strip club visits, and golf outings, sometimes including their spouses or employees. Additionally, cardiologists were allegedly compensated for making brief appearances at international conferences or provided with business class flights. Another aspect of the scheme involved a trainee program where
Biotronik employees observed cardiologists during the implantation of ICDs, for which the cardiologists were paid $ 400. Despite concerns raised by the compliance department, the payments continued. The alleged kick-back system, intended to encouraged the use of Biotronik products, occurred between 2013 and 2021. Although Biotronik denied the allegations, they settled with the US authorities without admitting guilt, paying nearly $ 13 million.
429:
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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.
22:
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362:(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.
856:
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cardiologist, significantly inflating his earnings per procedure. Despite later advice from medical professionals that the pacemaker was not needed, it could not be removed without risking heart damage. As a result, the jury awarded
Sowards $ 2.3 million in compensatory damages and $ 65 million in punitive damages.
346:(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.
1381:
Hindricks, Gerhard; Taborsky, Milos; Glikson, Michael; Heinrich, Ullus; Schumacher, Burghard; Katz, Amos; Brachmann, Johannes; Lewalter, Thorsten; Goette, Andreas; Block, Michael; Kautzner, Josef; Sack, Stefan; Husser, Daniela; Piorkowski, Christopher; Søgaard, Peter; IN-TIME study group (16 August
1923:
1105:
In July 2022, Biotronik resolved a prolonged legal dispute in the USA by agreeing to a multimillion dollar settlement. The case involved allegations from two whistleblowers, who were former independent sales representatives, concerning a kick-back scheme. According to the whistleblowers the scheme
496:
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
1097:
In a landmark case from New Mexico in 2016, a jury found
Biotronik negligent for unnecessarily implanting a pacemaker in Tommy Sowards due to an alleged conspiracy involving the company, a salesman, a hospital, and a cardiologist. The lawsuit exposed a scheme where Biotronik paid kickbacks to the
365:
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
484:
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
468:
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®
357:
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
480:
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
1101:
Biotronik is under investigation in the
Netherlands, with inquiries initiated in autumn 2020. This investigation, reported by Der Spiegel and the Dutch newspaper NRC Handelsblad, focuses on suspicions that medical specialists received millions of euros to promote Biotronik products. Over ten
409:
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.
404:
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
463:
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
1899:
1093:
In 2014, Biotronik faced allegations regarding kickback payments to cardiologists, leading to a settlement of nearly five million dollars. Currently, another case is ongoing in the
California Central District Court. Additionally,
321:
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).
509:
BIOTRONIK collaborates with the EPIC Alliance, a global network of female electrophysiologists. The alliance aims to enhance collaboration and support for women in the field of electrophysiology.
421:, 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
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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.
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residences have been searched, and assets worth 3.1 million euros belonging to medical specialists have been confiscated. Biotronik has not provided comments on these allegations.
498:
1999:
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501:' Technical Science Prize, first awarded to Till Schlösser. The CARDIOSTIM Innovation Award for Practice Improvement was granted to BIOTRONIK for its MRI AutoDetect.
1720:
1746:"Office of Public Affairs | Biotronik Inc. to Pay $ 4.9 Million to Resolve Claims that Company Paid Kickbacks to Physicians | United States Department of Justice"
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Cardiac rhythm management: pacemakers, implantable defibrillators, electrodes, cardiac monitors, external monitoring and programming devices
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In February 2016, BIOTRONIK Inc. opened an Education and Innovation Center, a training facility and meeting location in New York City.
2110:
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devices and leads implanted worldwide. To navigate through this portfolio, BIOTRONIK invented two online tools in 2016 and 2017; the
936:
401:). Home Monitoring has shown significant clinical benefits, including over a 50% reduction in mortality of heart failure patients.
105:
1924:"Medical Device Manufacturer Biotronik Inc. Agrees To Pay $ 12.95 Million To Settle Allegations of Improper Payments to Physicians"
1846:
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474:
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Vascular intervention: products for coronary and peripheral functions including stent systems, balloon catheters and guide wires
43:
521:
Electrophysiology: products for electrophysiological examinations and therapy, including ablation and diagnostic catheters
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2115:
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1900:"Medical Device Manufacturer Biotronik Pays $ 12.95M to Settle Qui Tam Whistleblower Lawsuit over Physician Kickbacks"
58:
1384:"Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial"
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1973:
39:
32:
2000:"Biotronik Inc. medical device manufacturer to pay $ 12.95 million to settle allegations of kickbacks to doctors"
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393:. With Philos, the company has offered a complete pacemaker family with telemetry since 2000, when it received
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approval for the product, and also successfully implanted the first pacemaker with Home Monitoring (
1462:"Lake Oswego medical device firm, BIOTRONIK, will settle federal kickback claims for $ 4.9 million"
796:
354:
339:
285:
139:
1796:
1489:"Groundbreaking Oregon DOJ cases target doctors' failure to inform patients about device payments"
1928:
Office of Inspector General | Government Oversight | U.S. Department of Health and Human Services
1725:
Office of Inspector General | Government Oversight | U.S. Department of Health and Human Services
1721:"Biotronik Inc. to Pay $ 4.9 Million to Resolve Claims that Company Paid Kickbacks to Physicians"
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The company offers equipment for diagnosis, treatment, and therapy support in the areas of
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1661:"BIOTRONIK opens state-of-the-art Education and Innovation Center in New York City"
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products and vascular intervention products. BIOTRONIK also develops and produces
1974:"The Wreck of the Andrea Doria and the Biotronik Anti-Kickback Enforcement Action"
1611:"BIOTRONIK CardioMessenger Smart shares pacemaker and ICD data with cardiologists"
829:
1874:"Biotronik Anti-Kickback Enforcement Action: Bribery Schemes and Lessons Learned"
1507:"Oregon DOJ case means doctors could tell patients ties to drug, implant makers"
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864:
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1636:"BIOTRONIK's BioMonitor 2 implantable wireless ECG recorder approved in Europe"
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Biotronik employs more than 9,000 people worldwide in over 100 countries, with
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342:(1936–2001), a professor of biomedical technology at the Friedrich-Alexander-
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In 1994 and 1995 respectively, BIOTRONIK began offering a full spectrum of
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Rivacor, Acticor, Intica NEO, Ilivia, Inventra, Iperia, Idova, Ilesto,
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BIOTRONIK began with the development of the first German implantable
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Ministry of Education and Research. In 2010, BIOTRONIK endowed the
950:
Edora, Evity, Enitra, Enticos, Eluna, Epyra, Etrinsa, Entovis, Evia
872:
Edora, Evity, Enitra, Enticos, Eluna, Epyra, Etrinsa, Evia, Entovis
1847:"Cardiologists earned rent as stakeholders in hospital site – NRC"
854:
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The following year, BIOTRONIK launched BioMonitor, a type of mini
453:
427:
368:
1949:"Biotronik to Pay $ 12.95 Million in False Claims Act Settlement"
570:, Germany, Competence Centre for Stent Development and Production
460:
413:
In 2011, BIOTRONIK was the subject of an investigation by the
15:
1305:[What is and how does CRT and home monitoring work?]
1045:(Passeo-18 Lux, Passeo-35, Passeo-35 HP, Passeo-14, Passeo-18
2026:
957:
Corox OTW, Sentus OTW BP, Sentus OTW QP, Sentus OTW QP xx/49
564:, Centre for Technology and Service, with over 130 employees
265:
1772:"Appeals court tosses whistleblower suit against Biotronik"
1243:
LĂĽderitz, Berndt (August 2001). "Max Schaldach 1936-2001".
334:(Biotronik IP-03) in 1963. The pacemaker was developed at
1326:"Geschichte der Herzschrittmacher-Therapie in Deutschland"
1311:
Herz-Blatt: Die InformationsbroschĂĽre fĂĽr unsere Patienten
1082:
Cardio Messenger, CardioMessenger 2, CardioMessenger Smart
991:
Balloon-expanding cobalt chromium coronary stent systems (
1303:"Was ist und wie funktioniert CRT und Home Monitoring?"
2032:
1194:"BIOTRONIK SE & Co KG - Company Profile and News"
499:
Berlin-Brandenburg Academy of Sciences and Humanities
358:
develop circuits for pacemakers. In the 1980s, the
247:
Dr. Alexander Uhl, Dr. Andreas Hecker, Holger Krumel
1031:
Dynamic, Dynamic Renal, PRO-Kinetic Energy Explorer
261:
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46:. Unsourced material may be challenged and removed.
1822:"Unnecessary Surgery | Biotronik Pacemaker Lawyer"
295:research and technology company, headquartered in
444:, a historical brick postal building on Berlin's
2106:Multinational companies headquartered in Germany
1440:"Tipping the odds for a maker of heart implants"
551:, company headquarters with over 2,400 employees
1533:"Neuer Investor - alte Probleme fĂĽr C/O Berlin"
710:, manufacturing of stents and balloon catheters
349:In 1976, the company moved to Sieversufer 8 in
1330:Herzschrittmachertherapie + Elektrophysiologie
1005:Pantera Pro, Pantera, Pantera LEO, AngioSculpt
915:AlCath Flux eXtra Gold, AlCath Flutter, AlCath
1162:"BIOTRONIK SE & Co. KG – company profile"
8:
1313:(in German). Herz Charite: 9. February 2008.
799:, US headquarters and manufacturing facility
118:
1820:DeShaw, Esq. P.C., Dr. Aaron (2016-02-27).
1797:"Biotronik settles kickbacks case for $ 5m"
1038:Astron, Astron Pulsar, Pulsar-18, Pulsar-35
417:(US DoJ) into payments made to doctors in
117:
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1119:
106:Learn how and when to remove this message
2131:Technology companies established in 1963
2121:Manufacturing companies based in Berlin
2101:Medical technology companies of Germany
2039:
1115:
943:Ilivia, Inventra, Ipera, Idova, Ilesto,
440:In 2012, the company acquired the old
373:BIOTRONIK in the Czech Republic, 2011.
1868:
1866:
1080:Patient devices for Home Monitoring (
879:Solia, Safio S, Siello, Setrox, Selos
7:
2141:German companies established in 1963
1221:[Your heart in safe hands].
805:, US education and innovation center
353:. In 1979, a US production site in
225:Germany, Switzerland, USA, Singapore
44:adding citations to reliable sources
2136:1963 establishments in West Germany
415:United States Department of Justice
130:BIOTRONIK current logo and wordmark
1998:Newman, Jeffrey. A. (2022-07-22).
1075:Renamic, Reocor, ICS 3000, Reliaty
981:Bio-resorbable scaffold (Magmaris)
14:
1029:Balloon-expanding stent systems (
1026:Peripheral vascular intervention
997:Drug-releasing balloon catheter (
2078:
2066:
2054:
2042:
1012:Cruiser, Galeo Pro, Galeo Magnum
920:Steerable diagnostic catheters (
436:, acquired in 2012 by BIOTRONIK.
344:University of Erlangen-Nuremberg
124:
20:
1487:Budnick, Nick (6 August 2013).
1245:Clinical Research in Cardiology
993:PRO-Kinetic Energy, PK Papyrus)
978:Coronary vascular intervention
964:Selectra, ScoutPro, ScoutPro IC
360:dual-chamber stimulation method
31:needs additional citations for
1845:Darroch, Gordon (2022-12-05).
1795:Perriello, Brad (2014-11-07).
1770:Perriello, Brad (2017-12-04).
1691:"CARDIOSTIM Innovation Awards"
1036:Self-expanding stent systems (
962:Lead systems and accessories (
1:
1438:Meier, Barry (2 April 2011).
1402:10.1016/S0140-6736(14)61176-4
1219:"Su corazĂłn en manos seguras"
859:BIOTRONIK ICS 3000 and PK-199
336:Technische Universität Berlin
1898:Strauss, Mark (2022-08-16).
1448:International New York Times
1217:Biotronik, BO (2007-09-07).
1066:Insertable cardiac monitor (
846:, New South Wales, Australia
485:insertable cardiac monitor.
448:in the sub-neighbourhood of
338:by physicist Professor. Dr.
284:; Biotronik Worldwide) is a
1324:Lemke, Bernd (2024-03-01).
984:Drug-eluting stent system (
929:Qubic RF, Qubic Stim, Qiona
901:Linox smart, Protego, Plexa
174:; 61 years ago
2157:
1342:10.1007/s00399-024-01010-4
529:Headquarters and locations
2111:Cardiac electrophysiology
1583:"Zero-Gravity fact sheet"
937:Cardiac resynchronization
399:remote patient monitoring
123:
119:BIOTRONIK SE & Co. KG
1068:BioMonitor 2, BioMonitor
534:Europe & Middle East
319:research and development
204:Woermannkehre 1, 12359,
1537:Der Tagesspiegel Online
1182:(subscription required)
391:coronary artery disease
860:
851:Products and therapies
437:
374:
1257:10.1007/s003920170130
1133:"BIOTRONIK – Imprint"
858:
832:, Brazil (since 1982)
452:, in the district of
446:Oranienburger Strasse
431:
389:for the treatment of
372:
1665:www.BusinessWire.com
1057:Introducer sheaths (
971:Streamer, VisionWire
941:CRT defibrillators (
913:Ablation catheters (
40:improve this article
2116:Implants (medicine)
1904:Mark A. Strauss Law
1052:Cruiser-18, Cruiser
1003:Balloon catheters (
797:Lake Oswego, Oregon
477:, correspondingly.
475:ProMRI®Configurator
355:Lake Oswego, Oregon
286:limited partnership
214:Number of locations
140:Limited partnership
120:
1695:www.CARDIOSTIM.com
1671:. 24 February 2016
1073:External devices (
1043:Balloon catheters
1019:3Flow, Neptune Pad
927:External devices (
861:
568:Rostock-WarnemĂĽnde
471:ProMRI®SystemCheck
450:Spandauer Vorstadt
438:
375:
161:Medical technology
2027:www.BIOTRONIK.com
1826:www.deshawlaw.com
1667:(Press release).
1468:. 7 November 2014
1396:(9943): 583–590.
1283:www.biotronik.com
1137:www.BIOTRONIK.com
909:Electrophysiology
811:, Ontario, Canada
383:balloon catheters
379:electrophysiology
308:electrophysiology
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266:www.BIOTRONIK.com
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1558:"About ProMRI"
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2007:. Retrieved
2003:
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1980:. 2022-07-06
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1955:. 2022-07-22
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1930:. 2022-07-25
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1880:. 2022-07-27
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1851:DutchNews.nl
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1752:. 2014-11-06
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1727:. 2021-01-06
1724:
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1703:. Retrieved
1699:the original
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1333:
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1282:
1279:"Our people"
1273:
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1227:. Retrieved
1225:(in Spanish)
1222:
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1197:
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38:Please help
33:verification
30:
1539:(in German)
1139:. BIOTRONIK
887:Tachycardia
865:Bradycardia
826:, Argentina
697:Switzerland
661:Netherlands
442:Postfuhramt
434:Postfuhramt
432:The former
299:, Germany.
276:(BIOTRONIK
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55:"Biotronik"
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1984:2024-08-26
1959:2024-08-26
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1831:2024-08-26
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1801:MassDevice
1781:2024-08-26
1776:MassDevice
1756:2024-08-26
1731:2024-08-26
1543:2021-05-06
1389:The Lancet
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1229:2024-03-27
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1110:References
644:Kohav Yair
293:biomedical
280:& Co.
243:Key people
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765:New Delhi
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332:pacemaker
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1567:24 March
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1059:Fortress
889:therapy
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667:Nijmegen
621:Hørsholm
562:Erlangen
312:vascular
252:Products
191:Founders
146:Industry
96:May 2014
2085:Science
2049:Germany
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1418:5509510
1382:2014).
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