Biotronik

BIOTRONIK began with the development of the first German implantable pacemaker (Biotronik IP-03) in 1963. The pacemaker was developed at Technische Universität Berlin by physicist Professor. Dr. Max Schaldach (1936–2001{{Cite journal |last=Lüderitz |first=Berndt |date=August 2001 |title=Max Schaldach 1936-2001 |url= |journal=Clinical Research in Cardiology |volume=90 |issue=8 |pages=596–597 |doi=10.1007/s003920170130 |issn=1861-0684}}),{{Cite web |title=Our people |url=https://www.biotronik.com/en-us/careers/why-us/our-people#:~:text=Since%20BIOTRONIK%20was%20founded%20in,worked%20for%20the%20company%20worldwide. |access-date=2024-03-27 |website=www.biotronik.com}}{{Cite journal |date=February 2008 |title=Was ist und wie funktioniert CRT und Home Monitoring? |trans-title=What is and how does CRT and home monitoring work? |url=https://herz.charite.de/fileadmin/user_upload/microsites/m_cc11/herz/zeitung-herzblatt/Herz-Blatt_02_08.pdf |journal=Herz-Blatt: Die Informationsbroschüre für unsere Patienten |language=German |publisher=Herz Charite |pages=9}} a professor of biomedical technology at the Friedrich-Alexander-University of Erlangen-Nuremberg (FAU),{{Cite journal |last=Lemke |first=Bernd |date=2024-03-01 |title=Geschichte der Herzschrittmacher-Therapie in Deutschland |url=https://doi.org/10.1007/s00399-024-01010-4 |journal=Herzschrittmachertherapie + Elektrophysiologie |language=de |volume=35 |issue=1 |pages=18–54 |doi=10.1007/s00399-024-01010-4 |issn=1435-1544 |pmc=10924011 |pmid=38421397}} 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.{{Citation needed|date=August 2021}}

In 1976, the company moved to Sieversufer 8 in Berlin-Neukölln. 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-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.

File:Pankrác, Biotronik z Hvězdovy.jpg

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.{{Cite journal|url=http://www.TheLancet.com/journals/lancet/article/PIIS0140-6736(14)61176-4/fulltext|title=Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial|doi=10.1016/S0140-6736(14)61176-4|pmid=25131977|access-date=22 April 2016|volume=384|issue=9943|journal=The Lancet|pages=583–590|date=16 August 2014|last1=Hindricks|first1=Gerhard|last2=Taborsky|first2=Milos|last3=Glikson|first3=Michael|last4=Heinrich|first4=Ullus|last5=Schumacher|first5=Burghard|last6=Katz|first6=Amos|last7=Brachmann|first7=Johannes|last8=Lewalter|first8=Thorsten|last9=Goette|first9=Andreas|last10=Block|first10=Michael|last11=Kautzner|first11=Josef|last12=Sack|first12=Stefan|last13=Husser|first13=Daniela|last14=Piorkowski|first14=Christopher|last15=Søgaard|first15=Peter|author16=IN-TIME study group|s2cid=5509510|url-access=subscription}}

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.{{Citation needed|date=August 2022}}

In 2011, BIOTRONIK was the subject of an investigation by the United States Department of Justice (US DoJ) into payments made to doctors in Nevada, United States, who use the company's products in their practices.{{Cite news|last=Meier|first=Barry|date=2 April 2011|url=https://www.NYTimes.com/2011/04/03/health/03implant.html|title=Tipping the odds for a maker of heart implants|website=www.NYTimes.com|publisher=International New York Times }} The case was settled in 2014.{{Cite web|url=http://www.OregonLive.com/health/index.ssf/2014/11/lake_oswego_medical_device_fir.html|title=Lake Oswego medical device firm, BIOTRONIK, will settle federal kickback claims for $4.9 million|website=OregonLive.com|date=7 November 2014 |access-date=22 April 2016}} In 2013, a similar investigation began and was settled involving payments to physicians in Oregon.{{Cite news|last=Budnick|first=Nick|date=6 August 2013|title=Groundbreaking Oregon DOJ cases target doctors' failure to inform patients about device payments|url=http://www.OregonLive.com/health/index.ssf/2013/08/groundbreaking_oregon_doj_case.html|website=OregonLive.com }}{{Cite web|url=http://www.OregonLive.com/health/index.ssf/2013/08/oregon_case_suggests_patients.html|title=Oregon DOJ case means doctors could tell patients ties to drug, implant makers|website=OregonLive.com|date=17 August 2013 |access-date=22 April 2016}}

File:Berlin, Mitte, Oranienburger Strasse 35-36, Postfuhramt.jpg, acquired in 2012 by BIOTRONIK.]]

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, in the district of Mitte.{{Cite news|title=Neuer Investor - alte Probleme für C/O Berlin|url=https://www.TagesSpiegel.de/kultur/c-o-berlin-neuer-investor-alte-probleme-fuer-c-o-berlin/7047666.html|access-date=2021-05-06|newspaper=Der Tagesspiegel Online|language=de}}

The following year, BIOTRONIK launched BioMonitor, 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. 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.{{Cite web|url=https://www.Biotronik.com/promri/en/about-promri|title=About ProMRI|website=BIOTRONIK.com|access-date=24 March 2017}} To navigate through this portfolio, BIOTRONIK invented two online tools in 2016 and 2017; the [https://www.ProMRIcheck.com/spring/main?execution=e3s1 ProMRI®SystemCheck] and [https://web.Archive.org/web/20170325025447/https://configurator.ProMRIcheck.com/config/location 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%.{{Cite web|url=https://biotronik.cdn.mediamid.com/cdn_bio_doc/bio24771/20905/bio24771.pdf|title=Zero-Gravity fact sheet|website=BIOTRONIK.com|access-date=24 March 2017}}

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,{{Cite web|url=http://www.MedGadget.com/2015/05/biotronik-cardiomessenger-smart-shares-pacemaker-and-icd-data-with-cardiologists.html|title=BIOTRONIK CardioMessenger Smart shares pacemaker and ICD data with cardiologists|website=MedGadget.com|access-date=22 April 2016}} and BioMonitor 2, the second-generation insertable cardiac monitor.{{Cite web|url=http://www.MedGadget.com/2015/09/biotroniks-biomonitor-2-implantable-wireless-ecg-recorder-approved-europe.html|title=BIOTRONIK's BioMonitor 2 implantable wireless ECG recorder approved in Europe|website=MedGadget.com|access-date=22 April 2016}}

In February 2016, BIOTRONIK Inc. opened an Education and Innovation Center, a training facility and meeting location in New York City.{{Cite press release|url=http://www.BusinessWire.com/news/home/20160224006271/en/BIOTRONIK-Opens-State-of-the-Art-Education-Innovation-Center-York|title=BIOTRONIK opens state-of-the-art Education and Innovation Center in New York City|website=www.BusinessWire.com|date=24 February 2016 |publisher=Business Wire|access-date=24 March 2017}}

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. The CARDIOSTIM Innovation Award for Practice Improvement was granted to BIOTRONIK for its MRI AutoDetect.{{Cite web|url=http://www.CARDIOSTIM.com/site/GB/Exhibits/Innovation_Awards,I1447.htm|title=CARDIOSTIM Innovation Awards|website=www.CARDIOSTIM.com|access-date=23 March 2017|archive-url=https://web.archive.org/web/20170324173927/http://www.cardiostim.com/site/GB/Exhibits/Innovation_Awards,I1447.htm|archive-date=24 March 2017 }}

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.

• 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

• Pymble, New South Wales, Australia

File:ICS3000 PK199.jpg

• Bradycardia therapy
• Pacemakers (Edora, Evity, Enitra, Enticos, Eluna, Epyra, Etrinsa, Evia, Entovis)
• Electrodes (Solia, Safio S, Siello, Setrox, Selos)
• Tachycardia therapy
• Defibrillators (Rivacor, Acticor, Intica NEO, Ilivia, Inventra, Iperia, Idova, Ilesto,)
• Electrodes (Linox smart, Protego, Plexa)
• Electrophysiology
• Ablation catheters (AlCath Flux eXtra Gold, AlCath Flutter, AlCath)
• Steerable diagnostic catheters (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)

In 2014, Biotronik faced allegations regarding kickback payments to cardiologists, leading to a settlement of nearly five million dollars.{{Cite web |date=2021-01-06 |title=Biotronik Inc. to Pay $4.9 Million to Resolve Claims that Company Paid Kickbacks to Physicians |url=https://oig.hhs.gov/fraud/enforcement/biotronik-inc-to-pay-49-million-to-resolve-claims-that-company-paid-kickbacks-to-physicians/ |access-date=2024-08-26 |website=Office of Inspector General {{!}} Government Oversight {{!}} U.S. Department of Health and Human Services |language=en}}{{Cite web |date=2014-11-06 |title=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 |url=https://www.justice.gov/opa/pr/biotronik-inc-pay-49-million-resolve-claims-company-paid-kickbacks-physicians |access-date=2024-08-26 |website=www.justice.gov |language=en}}{{Cite web |last=Perriello |first=Brad |date=2017-12-04 |title=Appeals court tosses whistleblower suit against Biotronik |url=https://www.massdevice.com/appeals-court-tosses-whistleblower-suit-biotronik/ |access-date=2024-08-26 |website=MassDevice |language=en-US}}{{Cite web |last=Perriello |first=Brad |date=2014-11-07 |title=Biotronik settles kickbacks case for $5m |url=https://www.massdevice.com/biotronik-settles-kickbacks-case-5m/ |access-date=2024-08-26 |website=MassDevice |language=en-US}} Currently, another case is ongoing in the California Central District Court. Additionally,

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 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.{{Cite web |last=DeShaw, Esq. P.C. |first=Dr. Aaron |date=2016-02-27 |title=Unnecessary Surgery {{!}} Biotronik Pacemaker Lawyer |url=https://www.deshawlaw.com/blog/biotronik-pacemaker-lawyer |access-date=2024-08-26 |website=www.deshawlaw.com}}

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.{{Cite web |last=Darroch |first=Gordon |date=2022-12-05 |title=Cardiologists earned rent as stakeholders in hospital site – NRC |url=https://www.dutchnews.nl/2022/12/cardiologists-earned-rent-as-stakeholders-in-hospital-site-nrc/ |access-date=2024-08-26 |website=DutchNews.nl |language=en-GB}} Over ten 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.

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 entailed treating cardiologists to lavish dinners, winery tours, baseball games, strip club visits, and golf outings, sometimes including their spouses or employees.{{Cite web |date=2022-07-27 |title=Biotronik Anti-Kickback Enforcement Action: Bribery Schemes and Lessons Learned |url=https://www.jdsupra.com/legalnews/biotronik-anti-kickback-enforcement-9286763/ |access-date=2024-08-26 |website=JD Supra |language=en}} 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.{{Cite web |last=Strauss |first=Mark |date=2022-08-16 |title=Medical Device Manufacturer Biotronik Pays $12.95M to Settle Qui Tam Whistleblower Lawsuit over Physician Kickbacks |url=https://www.markastrausslaw.com/anti-kickback-statute/medical-device-manufacturer-biotronik-pays-12-95-million-to-settle-qui-tam-whistleblower-lawsuit-over-payment-of-alleged-kickbacks-to-physicians/ |access-date=2024-08-26 |website=Mark A. Strauss Law |language=en-US}} 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.{{Cite web |date=2022-07-25 |title=Medical Device Manufacturer Biotronik Inc. Agrees To Pay $12.95 Million To Settle Allegations of Improper Payments to Physicians |url=https://oig.hhs.gov/fraud/enforcement/medical-device-manufacturer-biotronik-inc-agrees-to-pay-1295-million-to-settle-allegations-of-improper-payments-to-physicians/#:~:text=(Biotronik),%20a%20medical%20device,of%20Biotronik's%20implantable%20cardiac%20devices, |access-date=2024-08-26 |website=Office of Inspector General {{!}} Government Oversight {{!}} U.S. Department of Health and Human Services |language=en}}{{Cite web |date=2022-07-22 |title=Biotronik to Pay $12.95 Million in False Claims Act Settlement |url=https://news.bloomberglaw.com/white-collar-and-criminal-law/biotronik-to-pay-12-95-million-in-false-claims-act-settlement |access-date=2024-08-26 |website=Bloomberg Law}}{{Cite web |date=2022-07-06 |title=The Wreck of the Andrea Doria and the Biotronik Anti-Kickback Enforcement Action |url=https://www.jdsupra.com/legalnews/the-wreck-of-the-andrea-doria-and-the-5499175/ |access-date=2024-08-26 |website=JD Supra |language=en}}{{Cite web |last=Newman |first=Jeffrey. A. |date=2022-07-22 |title=Biotronik Inc. medical device manufacturer to pay $12.95 million to settle allegations of kickbacks to doctors |url=https://jeffnewmanlaw.com/biotronik-inc-medical-device-manufacturer-to-pay-12-95-million-to-settle-allegations-if-kickbacks-to-doctors/ |access-date=2024-08-26 |website=Jeff Newman Law |language=en-US}}

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Category:German companies established in 1963