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), a professor of biomedical technology at the Friedrich-Alexander-
University of Erlangen-Nuremberg (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. In 1976, the company moved to Sieversufer 8 in
Britz,
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. 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. 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. 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. The case was settled in 2014. In 2013, a similar investigation began and was settled involving payments to physicians in
Oregon. , 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. 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. 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%. 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 insertable cardiac monitor. In February 2016, BIOTRONIK Inc. opened an Education and Innovation Center, a training facility and meeting location in New York City. 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. 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. 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. ==Awards==