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BIOTRONIK SE & Co. KG[1]
TypeLimited partnership[1]
Industry
Cardiovascular
Medical equipment, Medical technology
Founded1963; 63 years ago (1963), in Germany
FoundersMax Schaldach,
Otto Franke
HeadquartersWoermannkehre 1, 12359, Berlin, Germany[1][2]
Number of locations
Manufacturing
Germany, Switzerland, USA, Singapore
Area served
Worldwide
Key people
Holger Krumel CEO, Dr. Andreas Hecker
ProductsMedical devices
Websitewww.BIOTRONIK.com

Biotronik (BIOTRONIK SE & Co. KG;[1][2] Biotronik Worldwide) is a limited partnership[1] multi-national medical device company, headquartered in Berlin, Germany.

The company offers equipment for diagnosis, treatment, and therapy support in the areas of cardiac rhythm management, monitoring, electrophysiology, and neuromodulation.[3]

Biotronik employs more than 9,000 people worldwide in over 100 countries.[citation needed]

Biotronik has paid a handful of settlements to government agencies for kickback schemes to cardiologists to induce the use of their devices.

History

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[4]),[5][6] a professor of biomedical technology at the Friedrich-Alexander-University of Erlangen-Nuremberg (FAU),[7] and electrical engineer Otto Franke.

BIOTRONIK in the Czech Republic, 2011.

In 1994 and 1995 respectively, BIOTRONIK began offering a full spectrum of electrophysiology products and vascular intervention products. 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.[8]

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.[9] The case was settled in 2014.[10] In 2013, a similar investigation began and was settled involving payments to physicians in Oregon.[11][12]

The former Postfuhramt, 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.[13]

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,[14] and BioMonitor 2, the second-generation insertable cardiac monitor.[15]

In February 2016, BIOTRONIK Inc. opened an Education and Innovation Center, a training facility and meeting location in New York City.[16]

In 2023, Biotronik entered the neuromodulation market with the FDA approval of its Prospera™ Spinal Cord Stimulation (SCS) system,. The company simultaneously launched a new business segment, Biotronik Neuro, positioning the firm within the growing non‑opioid chronic pain therapy market.[17]

In February 2025, Biotronik announced a major strategic shift to concentrate on active implantable devices and digital health technologies, including artificial intelligence, remote patient monitoring, and connected‑care platforms. As part of this transition, the company agreed to divest its Vascular Intervention (VI) business to Teleflex, a deal expected to close in 2025.[18] The transaction was completed earlier than anticipated and transferred nearly all of Biotronik’s coronary and peripheral interventional product portfolio—including the Pantera Lux drug‑coated balloon catheter, the PK Papyrus covered coronary stent, and the ultrathin Orsiro Mission drug‑eluting stent—to Teleflex.[19]

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' Technical Science Prize, first awarded to Till Schlösser. The CARDIOSTIM Innovation Award for Practice Improvement was granted to BIOTRONIK for its MRI AutoDetect.[20]

Partnerships

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.

In October 2025, Biotronik and the University of Sydney entered a three‑year collaboration to co‑develop digital and connected cardiac‑care solutions. The partnership focuses on remote patient monitoring, AI‑enabled clinical decision support, and scalable digital tools aimed at improving care delivery, particularly for patients in remote or underserved regions. The program will be developed and tested in real‑world clinical settings through 2028.[21]

Criticism

In 2014, Biotronik faced allegations regarding kickback payments to cardiologists, leading to a settlement of nearly five million dollars.[22][23][24][25] 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.[26]

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.[27] 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.[28] 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.[29][28] 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.[30][31][32][33]

References

  1. 1 2 3 4 5 "BIOTRONIK – Imprint". www.BIOTRONIK.com. BIOTRONIK. Retrieved 26 August 2021.
  2. 1 2 "BIOTRONIK SE & Co. KG – company profile". www.Hoovers.com. D&B Hoovers. Retrieved 26 August 2021.(subscription required)
  3. ↑ "About Us | Biotronik". www.biotronik.com. Retrieved 2025-12-19.
  4. ↑ Lüderitz, Berndt (August 2001). "Max Schaldach 1936-2001". Clinical Research in Cardiology. 90 (8): 596–597. doi:10.1007/s003920170130. ISSN 1861-0684.
  5. ↑ "Our people". www.biotronik.com. Retrieved 2024-03-27.
  6. ↑ "Was ist und wie funktioniert CRT und Home Monitoring?" [What is and how does CRT and home monitoring work?] (PDF). Herz-Blatt: Die Informationsbroschüre für unsere Patienten (in German). Herz Charite: 9. February 2008.
  7. ↑ Lemke, Bernd (2024-03-01). "Geschichte der Herzschrittmacher-Therapie in Deutschland". Herzschrittmachertherapie + Elektrophysiologie (in German). 35 (1): 18–54. doi:10.1007/s00399-024-01010-4. ISSN 1435-1544. PMC 10924011. PMID 38421397.
  8. ↑ 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 2014). "Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial". The Lancet. 384 (9943): 583–590. doi:10.1016/S0140-6736(14)61176-4. PMID 25131977. S2CID 5509510. Retrieved 22 April 2016.
  9. ↑ Meier, Barry (2 April 2011). "Tipping the odds for a maker of heart implants". www.NYTimes.com. International New York Times.
  10. ↑ "Lake Oswego medical device firm, BIOTRONIK, will settle federal kickback claims for $4.9 million". OregonLive.com. 7 November 2014. Retrieved 22 April 2016.
  11. ↑ Budnick, Nick (6 August 2013). "Groundbreaking Oregon DOJ cases target doctors' failure to inform patients about device payments". OregonLive.com.
  12. ↑ "Oregon DOJ case means doctors could tell patients ties to drug, implant makers". OregonLive.com. 17 August 2013. Retrieved 22 April 2016.
  13. ↑ "Neuer Investor - alte Probleme für C/O Berlin". Der Tagesspiegel Online (in German). Retrieved 2021-05-06.
  14. ↑ "BIOTRONIK CardioMessenger Smart shares pacemaker and ICD data with cardiologists". MedGadget.com. Retrieved 22 April 2016.
  15. ↑ "BIOTRONIK's BioMonitor 2 implantable wireless ECG recorder approved in Europe". MedGadget.com. Retrieved 22 April 2016.
  16. ↑ "BIOTRONIK opens state-of-the-art Education and Innovation Center in New York City". www.BusinessWire.com (Press release). Business Wire. 24 February 2016. Retrieved 24 March 2017.
  17. ↑ "Spinal Cord Stimulation (SCS) market, competition, Medtronic, Boston Scientific, Nevro, Abbott". www.neurotechreports.com. Retrieved 2025-12-19.
  18. ↑ "BIOTRONIK Driving the Future of Active Device Business". Cluster Gesundheitswirtschaft Berlin-Brandenburg. 2025-02-27. Retrieved 2025-12-19.
  19. ↑ Hudson, Jocelyn (2025-07-01). "Teleflex completes acquisition of Biotronik's Vascular Intervention business". Vascular News. Retrieved 2025-12-19.
  20. ↑ "CARDIOSTIM Innovation Awards". www.CARDIOSTIM.com. Archived from the original on 24 March 2017. Retrieved 23 March 2017.
  21. ↑ Johnson, Oliver (2025-10-27). "BIOTRONIK partners with University of Sydney to advance cardiac care with digital innovations". Med-Tech Insights. Retrieved 2025-12-19.
  22. ↑ "Biotronik Inc. to Pay $4.9 Million to Resolve Claims that Company Paid Kickbacks to Physicians". Office of Inspector General | Government Oversight | U.S. Department of Health and Human Services. 2021-01-06. Retrieved 2024-08-26.
  23. ↑ "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". www.justice.gov. 2014-11-06. Retrieved 2024-08-26.
  24. ↑ Perriello, Brad (2017-12-04). "Appeals court tosses whistleblower suit against Biotronik". MassDevice. Retrieved 2024-08-26.
  25. ↑ Perriello, Brad (2014-11-07). "Biotronik settles kickbacks case for $5m". MassDevice. Retrieved 2024-08-26.
  26. ↑ DeShaw, Esq. P.C., Dr. Aaron (2016-02-27). "Unnecessary Surgery | Biotronik Pacemaker Lawyer". www.deshawlaw.com. Retrieved 2024-08-26.
  27. ↑ Darroch, Gordon (2022-12-05). "Cardiologists earned rent as stakeholders in hospital site – NRC". DutchNews.nl. Retrieved 2024-08-26.
  28. 1 2 "Biotronik Anti-Kickback Enforcement Action: Bribery Schemes and Lessons Learned". JD Supra. 2022-07-27. Retrieved 2024-08-26.
  29. ↑ Strauss, Mark (2022-08-16). "Medical Device Manufacturer Biotronik Pays $12.95M to Settle Qui Tam Whistleblower Lawsuit over Physician Kickbacks". Mark A. Strauss Law. Retrieved 2024-08-26.
  30. ↑ "Medical Device Manufacturer Biotronik Inc. Agrees To Pay $12.95 Million To Settle Allegations of Improper Payments to Physicians". Office of Inspector General | Government Oversight | U.S. Department of Health and Human Services. 2022-07-25. Retrieved 2024-08-26.
  31. ↑ "Biotronik to Pay $12.95 Million in False Claims Act Settlement". Bloomberg Law. 2022-07-22. Retrieved 2024-08-26.
  32. ↑ "The Wreck of the Andrea Doria and the Biotronik Anti-Kickback Enforcement Action". JD Supra. 2022-07-06. Retrieved 2024-08-26.
  33. ↑ Newman, Jeffrey. A. (2022-07-22). "Biotronik Inc. medical device manufacturer to pay $12.95 million to settle allegations of kickbacks to doctors". Jeff Newman Law. Retrieved 2024-08-26.

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