Biotronik

BIOTRONIK SE & Co. KG^[1]

BIOTRONIK current logo and wordmark
Company type	Limited partnership[1]
Industry	Cardiovascular Medical equipment, Medical technology
Founded	1963; 61 years ago (1963), in Germany
Founders	Max Schaldach, Otto Franke
Headquarters	Woermannkehre 1, 12359, Berlin, Germany[1][2]
Number of locations	Manufacturing Germany, Switzerland, USA, Singapore
Area served	Worldwide
Key people	Dr. Alexander Uhl, Dr. Andreas Hecker, Holger Krumel
Products	Medical devices
Website	www.BIOTRONIK.com

Biotronik (BIOTRONIK SE & Co. KG;^[1][2] Biotronik Worldwide) is a limited partnership^[1] multi-national cardiovascular biomedical research and technology company, headquartered in Berlin, Germany.

The company offers equipment for diagnosis, treatment, and therapy support in the areas of cardiac rhythm management, electrophysiology, and vascular intervention.^[3] 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.^[4]

Biotronik employs more than 9,000 people worldwide in over 100 countries, with research and development 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).^{[citation needed]}

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^[5]),^[6][7] a professor of biomedical technology at the Friedrich-Alexander-University of Erlangen-Nuremberg (FAU),^[8] 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]}

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.

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.^[9]

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]}

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.^[10] The case was settled in 2014.^[11] In 2013, a similar investigation began and was settled involving payments to physicians in Oregon.^[12][13]

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.^[14]

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.^[15] To navigate through this portfolio, BIOTRONIK invented two online tools in 2016 and 2017; the ProMRI®SystemCheck and 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%.^[16]

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,^[17] and BioMonitor 2, the second-generation insertable cardiac monitor.^[18]

In February 2016, BIOTRONIK Inc. opened an Education and Innovation Center, a training facility and meeting location in New York City.^[19]

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]

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

• 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.^{[21][22][23][24]} 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.^[25]

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.^[26] 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.^[27] 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.^[28][27] 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.^{[29][30][31][32]}

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