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]
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[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.
BIOTRONIK in the Czech Republic, 2011.
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]
The former Postfuhramt, acquired in 2012 by BIOTRONIK.
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]
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.
Patient devices for Home Monitoring (Cardio Messenger, CardioMessenger 2, CardioMessenger Smart)
Criticism
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]
Related Research Articles
Cardiology is the study of the heart. Cardiology is a branch of medicine that deals with disorders of the heart and the cardiovascular system. The field includes medical diagnosis and treatment of congenital heart defects, coronary artery disease, heart failure, valvular heart disease, and electrophysiology. Physicians who specialize in this field of medicine are called cardiologists, a sub-specialty of internal medicine. Pediatric cardiologists are pediatricians who specialize in cardiology. Physicians who specialize in cardiac surgery are called cardiothoracic surgeons or cardiac surgeons, a specialty of general surgery.
An artificial cardiac pacemaker, commonly referred to as simply a pacemaker, is an implanted medical device that generates electrical pulses delivered by electrodes to one or more of the chambers of the heart. Each pulse causes the targeted chamber(s) to contract and pump blood, thus regulating the function of the electrical conduction system of the heart.
Defibrillation is a treatment for life-threatening cardiac arrhythmias, specifically ventricular fibrillation (V-Fib) and non-perfusing ventricular tachycardia (V-Tach). A defibrillator delivers a dose of electric current to the heart. Although not fully understood, this process depolarizes a large amount of the heart muscle, ending the arrhythmia. Subsequently, the body's natural pacemaker in the sinoatrial node of the heart is able to re-establish normal sinus rhythm. A heart which is in asystole (flatline) cannot be restarted by a defibrillator; it would be treated only by cardiopulmonary resuscitation (CPR) and medication, and then by cardioversion or defibrillation if it converts into a shockable rhythm.
An implantable cardioverter-defibrillator (ICD) or automated implantable cardioverter defibrillator (AICD) is a device implantable inside the body, able to perform defibrillation, and depending on the type, cardioversion and pacing of the heart. The ICD is the first-line treatment and prophylactic therapy for patients at risk for sudden cardiac death due to ventricular fibrillation and ventricular tachycardia.
A coronary catheterization is a minimally invasive procedure to access the coronary circulation and blood filled chambers of the heart using a catheter. It is performed for both diagnostic and interventional (treatment) purposes.
A balloon catheter is a type of "soft" catheter with an inflatable "balloon" at its tip which is used during a catheterization procedure to enlarge a narrow opening or passage within the body. The deflated balloon catheter is positioned, then inflated to perform the necessary procedure, and deflated again in order to be removed.
Cardiac electrophysiology is a branch of cardiology and basic science focusing on the electrical activities of the heart. The term is usually used in clinical context, to describe studies of such phenomena by invasive (intracardiac) catheter recording of spontaneous activity as well as of cardiac responses to programmed electrical stimulation - clinical cardiac electrophysiology. However, cardiac electrophysiology also encompasses basic research and translational research components. Specialists studying cardiac electrophysiology, either clinically or solely through research, are known as cardiac electrophysiologists.
Cardiac catheterization is the insertion of a catheter into a chamber or vessel of the heart. This is done both for diagnostic and interventional purposes.
Guidant Corporation, part of Boston Scientific and Abbott Labs, designs and manufactures artificial cardiac pacemakers, implantable cardioverter-defibrillators, stents, and other cardiovascular medical products. Their company headquarters is located in Indianapolis, Indiana. Their main competitors are Medtronic, St. Jude Medical, and Johnson and Johnson.
A catheterization laboratory, commonly referred to as a cath lab, is an examination room in a hospital or clinic with diagnostic imaging equipment used to visualize the arteries of the heart and the chambers of the heart and treat any stenosis or abnormality found.
St. Jude Medical, Inc. was an American global medical device company headquartered in Little Canada, Minnesota, U.S., a suburb of Saint Paul. The company had more than 20 principal operations and manufacturing facilities worldwide with products sold in more than 100 countries. Its major markets include the United States, Europe, Latin America and Asia-Pacific. The company was named after Jude the Apostle, the patron saint of lost causes.
Clinical cardiac electrophysiology, is a branch of the medical specialty of cardiology concerned with the study and treatment of rhythm disorders of the heart. Cardiologists with expertise in this area are usually referred to as electrophysiologists. Electrophysiologists are trained in the mechanism, function, and performance of the electrical activities of the heart. Electrophysiologists work closely with other cardiologists and cardiac surgeons to assist or guide therapy for heart rhythm disturbances (arrhythmias). They are trained to perform interventional and surgical procedures to treat cardiac arrhythmia.
Morton Maimon Mower was an American cardiologist specializing in electrophysiology and the co-inventor of the automatic implantable cardioverter defibrillator. He served in several professional capacities at Sinai Hospital and Cardiac Pacemakers Inc. In 1996, he became the chairman and chief executive officer of Mower Research Associates. He was inducted into the National Inventors Hall of Fame in 2002 for the development of the automatic implantable cardioverter defibrillator with Michel Mirowski in the 1970s. He continued his research in the biomechanical engineering laboratories at Johns Hopkins University.
Alois A. Langer is an American biomedical engineer best known as one of the co-inventors of the Implantable Cardioverter Defibrillator (ICD).
Cardiac resynchronisation therapy is the insertion of electrodes in the left and right ventricles of the heart, as well as on occasion the right atrium, to treat heart failure by coordinating the function of the left and right ventricles via a pacemaker, a small device inserted into the anterior chest wall.
A wearable cardioverter defibrillator (WCD) is a non-invasive, external device for patients at risk of sudden cardiac arrest (SCA). It allows physicians time to assess their patient's arrhythmic risk and see if their ejection fraction improves before determining the next steps in patient care. It is a leased device. A summary of the device, its technology and indications was published in 2017 and reviewed by the EHRA Scientific Documents Committee.
Cameron Health was a medical device developer based in San Clemente, California, US. Cameron Health had its European office, Cameron Health BV, in Arnhem, The Netherlands. The privately held company's focus was on a new generation of minimally invasive implantable cardioverter-defibrillator (ICD) which they called a Subcutaneous Implantable Defibrillator (S-ICD). Cameron Health's approach avoided implanting transvenous leads into the heart, which had been the usual procedure for cardiac devices. Instead, the Cameron ICD was entirely implanted outside the thoracic wall.
A hybrid cardiac surgical procedure in a narrow sense is defined as a procedure that combines a conventional, more invasive surgical part with an interventional part, using some sort of catheter-based procedure guided by fluoroscopy imaging in a hybrid operating room (OR) without interruption. The hybrid technique has a reduced risk of surgical complications and has shown decreased recovery time. It can be used to treat numerous heart diseases and conditions and with the increasing complexity of each case, the hybrid surgical technique is becoming more common.
Yaariv Khaykin is a Canadian cardiologist and a clinical researcher in the area of electrophysiology. He is the director of the Newmarket Electrophysiology Research Group at the Southlake Regional Health Centre. He has published research into complex ablation and pioneered cardiac ablation methods.
Sindh Institute of Cardio Vascular Diseases (SICVD) was first established as NICVD Satellite Center Sukkur on 24 February 2018. This 300 bed state-of-the-art cardiac facility in Sukkur has full facilities as are available in the National Institute of Cardiovascular Diseases, Karachi. In SICVD all the cardiac care services are provided free-of-charge, It is a complete cardiac hospital of international standard and is providing major cardiac facilities, especially interventional cardiology, to the people of Sindh at their doorstep for free. It is the largest cardiac centre in Sindh after the NICVD in Karachi.
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