BIOTRONIK

What BIOTRONIK does

BIOTRONIK SE & Co. KG is a privately held, Berlin-headquartered medical technology company founded in 1963 that develops, manufactures and sells active implantable devices across three core franchises: Cardiac Rhythm Management (pacemakers, ICDs, CRT devices and implantable cardiac monitors), Neuromodulation (the Prospera spinal cord stimulation system for chronic pain), and Electrophysiology (Pulsed Field Ablation systems distributed via CardioFocus and developed in-house as ElePulse). Its differentiated technology platform centers on DX Technology (a single-lead ICD with a floating atrial dipole for AF detection), Closed Loop Stimulation (impedance-based physiologic rate response), the world's first CE-approved complete Left Bundle Branch Area Pacing system (Solia CSP leads and Selectra 3D catheters), the LivIQ leadless pacemaker using atrial far-field sensing for single-device AV synchrony, and the BIOMONITOR IV insertable cardiac monitor with on-device AI (SmartECG) for false-positive reduction. The company also operates the proprietary Home Monitoring remote patient monitoring platform, CardioSphere clinician software, and the Patient App, with integrations into MiCare Path for extended US cardiology RPM programs.

BIOTRONIK generates revenue primarily through hardware sales of these implantable devices and their associated leads, catheters and programmers to hospitals, cardiac electrophysiology centers and pain management specialists, with an emerging recurring service layer via Home Monitoring, Atlas Alert Optimization, and BioVantage Remote Care Review for Prospera patients. Clinical evidence — including the MATRIX study (2,054 patients), CRT-NEXT, BIO|WOMEN, BIO|REDUCE and the 325-patient BIO-LivIQ pivotal trial across 60 sites — supports a go-to-market model built around direct field sales, physician training programs (HRS, ESC, EHRA, ACC conferences), peer-reviewed publications, and selected distribution partnerships (CardioFocus for Centauri PFA, IMDS for Micro Rx, Texray for radiation protection, Egg Medical for EggNest). Manufacturing and R&D are anchored at the Berlin HQ and the Singapore Asia-Pacific Hub (BIOHUB), with US operations from Lake Oswego, Oregon.

In July 2025 BIOTRONIK sold its Vascular Intervention business (drug-coated balloons, stents, resorbable magnesium scaffolds) to Teleflex for approximately $895M (EUR 760M), explicitly refocusing the remaining company on its CRM, Neuromodulation and EP franchises. Post-divestiture, BIOTRONIK is launching or expanding its flagship next-generation platforms — Acticor Sky / Rivacor Sky (FDA approval April 2026), LivIQ leadless pacemaker (global pivotal trial 2026), BIOMONITOR IV with AI (commercial launch April 2025), and the CE-marked Acticor/Rivacor Sky LBBAP system (first EU implant at University Hospital Frankfurt in February 2026) — while pursuing ecosystem partnerships with Charité / German Heart Center Foundation, the University of Sydney's Westmead Applied Research Centre, MiCare Path, and Flex Databases to build AI-driven decision support and digital cardiology capabilities across 100+ countries.

Name

BIOTRONIK

Legal name

BIOTRONIK SE & Co. KG

Website

https://biotronik.com

Company type

Private

Founded year

1963

Operating status

Operating

Headcount range

5,001–10,000 employees

Short description

BIOTRONIK is a privately held Berlin-based medical technology company that develops and sells implantable cardiac rhythm management devices (pacemakers, ICDs, CRT systems, insertable cardiac monitors), spinal cord stimulation systems, and electrophysiology products, selling through direct field sales to hospitals and cardiac centers across 100+ countries.

Ownership category

akta.pro rank

Product category

Cardiac Rhythm Management Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Cardiac Rhythm Management (Pacemakers, ICDs, CRT) (HLAHAFAC)

akta.pro secondary industries

Implantable Neuromodulation & Neurostimulation (SCS/DBS/VNS/PNS) (HLAHAEAK), Electrophysiology Mapping & Ablation Systems (HLAHAFAD), Connected Medical Devices & Wearables (Sensors, Patches, Implantables) (HLACAPAB)

Keywords

• Cardiac rhythm management
• Implantable medical devices
• Spinal cord stimulation
• Cardiac resynchronization therapy
• Remote patient monitoring

Headquarters

HQ city

Berlin

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Supply Chain, Operations, Marketing or Sales, Infrastructure, Others

Revenue model

1. Cardiac Rhythm Management Devices: Sale of pacemakers, ICDs, CRT devices, and related leads for treating cardiac arrhythmias and heart failure. Devices are implanted in hospitals and clinics with physician support.
2. Vascular Intervention Products: Sale of vascular intervention devices including drug-coated balloons, stents, guide catheters, and resorbable scaffolds. Business sold to Teleflex in 2025 for approximately $895 million (EUR 760 million).
3. Neuromodulation / Spinal Cord Stimulation: Sale of spinal cord stimulation systems for chronic pain management including Prospera SCS device with RESONANCE technology.
4. Remote Monitoring Services: Home Monitoring platform and related services enabling remote patient management and data transmission from implanted cardiac devices.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels7 records

Core offering

BIOTRONIK manufactures and sells active implantable medical devices for the diagnosis and treatment of cardiovascular disease and chronic pain. Its core offerings include pacemakers (Amvia, Edora, Evity, Enitra, Enticos families), implantable cardioverter-defibrillators (Acticor Sky, Rivacor Sky families), cardiac resynchronization therapy systems (CRT-DX two-lead systems), insertable cardiac monitors (BIOMONITOR IV with AI), spinal cord stimulation systems (Prospera SCS), and electrophysiology ablation systems. Products are supported by the BIOTRONIK Home Monitoring remote patient management platform and accompanying Patient App.

Product overview

BIOTRONIK is a global medical technology company with a comprehensive portfolio in Cardiac Rhythm Management (CRM), Neuromodulation, and Electrophysiology. The core CRM portfolio includes pacemakers (Amvia Edge/Sky, Edora, Evity, Enitra, Enticos families), ICDs (Acticor Sky, Rivacor Sky families with FDA approval for LBBAP), and CRT systems (defibrillators and pacemakers). The company offers insertable cardiac monitors (BIOMONITOR IV/IIIm) with AI-powered false positive reduction. Key differentiated technologies include DX Technology for single-lead atrial sensing, Closed Loop Stimulation for physiologic rate response, and conduction system pacing solutions (Solia CSP lead, Selectra 3D catheters). BIOTRONIK provides remote monitoring through its proprietary Home Monitoring platform and Patient App, integrated with MiCare Path RPM for extended care management. In Neuromodulation, the Prospera SCS system features RESONANCE multiphase stimulation with Embrace One remote monitoring. The Electrophysiology portfolio includes the Centauri PFA System (Europe) and ElePulse PFA System. BIOTRONIK also offers vascular intervention products including the Freesolve resorbable magnesium scaffold, though this business was sold to Teleflex in 2025.

Differentiator

Problem solved

Functional benefit

Brands

• Prospera: Spinal cord stimulation system for chronic pain management featuring RESONANCE multiphase stimulation technology
• BIOTRONIK Home Monitoring
• DX Technology
• LivIQ
• Acticor Sky
• Rivacor Sky
• BIOMONITOR IV
• BIOTRONIK Patient App
• Embrace One
• Freesolve

Products and services

• Pacing Systems (Pacemakers) Implantable pacemakers for the treatment of bradycardia and other cardiac conduction disorders, including Amvia Edge, Amvia Sky, Edora 8, Evity 8/6, Enitra 8/6, and Enticos 4 families available in single-chamber (SR-T) and dual-chamber (DR-T) configurations for hospital electrophysiology programs.
• Acticor Sky Family ICD and CRT-D Systems FDA-approved next-generation implantable cardioverter-defibrillator (ICD) and CRT-D family featuring Left Bundle Branch Area Pacing (LBBAP), a built-in anti-tachycardia pacing suite, and single-lead DX Technology enabling atrial sensing without requiring a second atrial lead.
• Rivacor Sky Family ICD and CRT-D Systems Next-generation ICD and CRT-D systems with physiology-driven therapies, featuring LBBAP capability, DX Technology for atrial sensing, and streamlined workflows across care teams.
• Cardiac Resynchronization Therapy (CRT) Systems Cardiac resynchronization therapy defibrillators and pacemakers (Acticor HF-T, Rivacor HF-T, Amvia Edge HF-T) for heart failure treatment, featuring DX Technology enabling 2-lead CRT-DX systems as an alternative to conventional 3-lead therapy with fewer atrial lead complications.
• BIOMONITOR IV Insertable Cardiac Monitor with AI Insertable cardiac monitor featuring artificial intelligence (SmartECG) for false positive reduction; only ICM on market with PVC and PAC discrimination capabilities, industry-leading signal quality and transmission success for reliable remote patient management.
• BIOMONITOR IIIm Insertable Cardiac Monitor Insertable cardiac monitor for long-term monitoring of cardiac rhythms with wireless data transmission capabilities.
• Prospera Spinal Cord Stimulation (SCS) System Neuromodulation system for treatment of chronic pain, featuring RESONANCE multiphase stimulation paradigm and Embrace One ecosystem that provides automatic, objective, remote daily monitoring for proactive patient care.
• LivIQ Leadless Pacemaker Next-generation leadless pacemaker using advanced electrical atrial far-field sensing to deliver atrioventricular (AV) synchrony in a single-device VDD mode solution, designed for broad clinical scenarios including active patients.
• Centauri Pulsed Field Ablation (PFA) System Pulsed Field Ablation system for the treatment of atrial fibrillation, distributed in Europe through partnership with CardioFocus; features a focal PFA approach for pulmonary vein isolation.
• Solia CSP Conduction System Pacing Lead Conduction system pacing lead; the first and only pacing lead worldwide combining fixed screw design with stylet-driven implantation approach, designed to simplify CSP procedures while enhancing control and precision.
• Selectra 3D Lead Delivery Catheters Lead delivery system catheters designed for exceptional handling during conduction system pacing procedures, supporting left bundle branch area pacing (LBBAP) with enhanced maneuverability.
• BIOTRONIK Home Monitoring Remote Patient Monitoring Platform Wireless remote patient monitoring platform that automatically transmits patient data from BIOTRONIK cardiac devices to clinicians, enabling proactive patient management and early detection of cardiac events, with demonstrated 99.7 percent AF detection accuracy for episodes of one hour or more.
• Plexa ICD Leads ICD leads including Plexa and Pamira families for reliable electrical signaling in BIOTRONIK's cardiac rhythm management devices.
• Sentus OTW QP Left Ventricular Lead Left ventricular lead for cardiac resynchronization therapy, designed for over-the-wire implantation with quadripolar configuration.

Quantifiable outcome

• Three times fewer atrial-lead complications with CRT-DX compared to conventional 3-lead CRT-D
• +6 more outcomes

Named customers8 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration7 records

AI capability8 records

Feature9 records

Partnerships

Eight partnerships are on record, tiered flagship, core and minor.

• Charité - Universitätsmedizin Berlin / German Heart Center FoundationflagshipStrategic or Co-development Partner · 19 May 2026Research and innovation partnership focused on advancing digital and translational cardiology. Combines Charité's clinical cardiovascular expertise at Deutsches Herzzentrum der Charité (DHZC) with BIOTRONIK's cardiac devices, AI, and connected health technologies. Initial projects focus on AI-driven tools and advanced simulation environments. Jointly funding an endowed professorship for Digital and Translational Cardiology at Charité.
• MiCare PathcoreGTM or Marketing Partner · 2 February 2026Strategic partnership delivering comprehensive remote physiologic monitoring program for US cardiology practices. Combines BIOTRONIK's BIOMONITOR IV insertable cardiac monitor with MiCare Path's RPM platform. Enables clinics to extend cardiac care beyond office visits with turnkey solution for cardiac monitoring programs.
• Flex DatabasesminorImplementation/ SI/ Consulting Partner · 30 November 2025Selected as global eClinical partner to support clinical trial operations and digital transformation. BIOTRONIK aims to improve reporting, oversight, and regulatory compliance through adoption of unified SaaS platform, moving from customized internal system.
• University of Sydney / Westmead Applied Research Centre (WARC)coreStrategic or Co-development Partner · 22 October 2025Three-year partnership (MoU through 2028) to jointly advance digital and connected health innovations. Combines BIOTRONIK's expertise in implanted cardiac devices and remote monitoring with WARC's patient-facing digital health tools. Focus areas include remote patient monitoring, AI, and clinical decision support. Aims to benefit patients in remote or underserved regions.
• CardioFocuscoreChannel Partner/ Reseller/ Distributor · 24 July 2025Exclusive distribution agreement for Centauri Pulsed Field Ablation (PFA) System in selected European countries. Centauri is a next-generation focal PFA system providing controllable and versatile solution for cardiac ablation in AF treatment.
• TexrayminorChannel Partner/ Reseller/ Distributor · 22 April 2025Multinational distribution partnership for Texray's innovative radiation protection head and neck protectors. BIOTRONIK distributes products in selected European and Middle Eastern countries.
• Egg MedicalminorChannel Partner/ Reseller/ Distributor · 22 April 2024Partnership offering EggNest Radiation Protection System for enhancing radiation protection for interventional healthcare workers in the US. Demonstrations available at HRS in BIOTRONIK Innovation Suite.
• IMDS (Interventional Medical Device Solutions)minorChannel Partner/ Reseller/ Distributor · 8 February 2024Partnership for Micro Rx catheter distribution in the US market. Micro Rx is a novel rapid exchange microcatheter for enhancing guidewire support during PCI. Fourth IMDS product distributed by BIOTRONIK in the US.

Scale indicators5 records

Recent moves7 records

Expansion highlights7 records

Direct peers

• Medtronic: Global leader in cardiac rhythm management, offering pacemakers, ICDs, CRT devices, the Micra leadless pacemaker family, and insertable cardiac monitors — directly competing with BIOTRONIK across virtually the entire CRM portfolio.
• Abbott Laboratories: Major CRM competitor following its St. Jude Medical acquisition, offering pacemakers, ICDs, CRT, the Aveir leadless pacemaker family, and Confirm Rx ICM — directly overlapping BIOTRONIK's core CRM business.
• Boston Scientific: Direct competitor in ICDs, CRT-D, and EMBLEM S-ICD, with expanded SCS/neuromodulation presence via the Axonics acquisition — overlapping with BIOTRONIK's CRM and Prospera SCS businesses.
• LivaNova: Direct neuromodulation competitor in spinal cord stimulation for chronic pain, overlapping with BIOTRONIK's Prospera SCS system and offering similar remote monitoring and recharge platforms.
• MicroPort Scientific Corporation: Cardiac rhythm management competitor with pacemakers, ICDs, and CRT products distributed globally — competes most directly with BIOTRONIK in Asia-Pacific and emerging markets.

Emerging players

• Saluda Medical: Emerging neuromodulation company with closed-loop SCS technology (Evoke system) — competes in the same chronic pain SCS market as Prospera, representing a technology-focused challenger to incumbent SCS players.
• iRhythm Technologies: Digital cardiac monitoring company offering the Zio long-term ambulatory ECG patch — adjacent competitor in arrhythmia detection, overlapping with BIOTRONIK's BIOMONITOR IV and Home Monitoring platform.

Others

• Integer Holdings Corporation: Medical device contract manufacturer supplying components and assemblies to CRM OEMs — comparable as an ecosystem participant supporting the broader CRM supply chain in which BIOTRONIK competes.

Broad incumbents

• Koninklijke Philips N.V. Large incumbent in cardiac care with image-guided therapy, electrophysiology, and patient monitoring — broader portfolio than BIOTRONIK but overlapping in EP ablation and remote cardiac monitoring.
• Stryker Corporation: Diversified medtech incumbent with neurotechnology, including SCS overlap with BIOTRONIK's Prospera — broader portfolio and not a direct CRM competitor but competes in neuromodulation pain therapy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/biotronikjobs
• LinkedInlinkedin.com/company/biotronik

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about BIOTRONIK