Cardiac Device Manufacturers

Based in Halethorpe, MD, Abiomed manufactures the Impella heart pump, a percutaneous catheter-based technology. This device provides hemodynamic support for patients with cardiogenic shock, severe coronary artery disease, or advanced heart failure, facilitating minimally invasive treatment options.

AliveCor manufactures AI-enabled, machine learning-powered ECG sensors and devices. Their product line includes the Kardia 12L, a portable 12-lead ECG device for healthcare professionals, and doctor-recommended personal ECG devices, serving millions of users globally.

Alpha Medical Instruments, Inc. is a manufacturing organization based in Mission Viejo, CA. The company specializes in the manufacturing and assembly of cardiac devices for the medical industry, providing critical services for the production of essential medical instruments.

Based in Santa Clara, CA, Ancora Heart is a medical device company developing innovative therapies for heart failure. They focus on the AccuCinch® Ventricular Restoration System, an investigational cardiac device with FDA Breakthrough Designation, designed to improve quality of life for patients. Clinical trials are ongoing.

Based in Salt Lake City, UT, Biomerics is a contract manufacturing partner specializing in the development and production of neurovascular and cardiovascular microcatheters. They offer end-to-end solutions, from design and materials engineering to finished medical devices, leveraging extensive expertise in polymer and metal for complex interventional components.

Based in Irvine, California, BridgeMed Solutions is an ISO 13485 certified contract manufacturer for the medical device industry. The company specializes in custom manufacturing of Transcatheter Heart Valves, including TAVR, TMVR, Tricuspid, and Pulmonic Valves, from design to final product.

Based in Miami Lakes, FL, Cordis is a leading manufacturer of cardiology and endovascular devices. The company provides a range of quality products and services for cardiovascular health globally.

Based in Houston, TX, CorInnova, Inc. develops a minimally invasive, non-blood contacting cardiac assist device for acute heart failure. The collapsible device conforms to the heart’s surface, gently compressing it to increase cardiac output. Operating without touching blood, it eliminates risks such as thrombosis and the need for anti-coagulants.

Edwards Lifesciences develops innovative patient-focused technologies for individuals fighting cardiovascular disease. The company specializes in advanced transcatheter heart valves, mitral and tricuspid solutions, surgical valve technologies, and implantable heart failure management devices. Their solutions aim to improve patient lives through pioneering medical advancements.

Based in Milpitas, CA, Elixir Medical is a company focused on developing disruptive medical technologies for vascular interventions. They re-imagine radical solutions in vascular medicine, with products such as the BIOADAPTOR and DESyne BDS Plus, backed by extensive clinical evidence and trials.

Based in Bellaire, TX, Evaheart, Inc. manufactures the EVAHEART®2 Left Ventricular Assist Device (LVAD). This implantable mechanical pump supports advanced heart failure patients. It features a hydraulically levitated “open vane” impeller, ensuring gentle blood circulation and native pulsatility, complemented by a novel double cuff tipless inflow cannula.

Based in Garland, TX, Galt Medical Corp. designs, develops, manufactures, and markets disposable medical devices. They specialize in vascular products, including introducers, guidewires, and drainage catheters, for peripheral, coronary, and pediatric vascular interventions.

Based in Denver, CO, Genesee BioMedical develops innovative cardiac surgery devices. The company offers a complete portfolio of annuloplasty rings and bands for mitral and tricuspid repair, specialized retractors for adult, pediatric, and neonatal cardiac surgery, and coronary graft markers, supporting open, port-access, and robotic-assisted procedures.

Indian Wells Medical, Inc., based in Lake Forest, CA, develops innovative medical devices for cardiology and electrophysiology. The company focuses on improving patient outcomes in cardiac procedures with products like the FlexPoint® Steerable Transseptal Needle (STSN) and FlexPoint® Piercing Stylet (PS), serving the healthcare market.

Based in Clarksville, TN, Insightra Medical is an FDA-approved manufacturer specializing in Intra-Aortic Balloon Pump (IABP) Catheters. As one of only three global producers, the company delivers high-quality, innovative cardiac devices. Insightra Medical is recognized for its excellence in the medical device industry, advancing cardiovascular care.

Based in Sunnyvale, CA, Intuitive Surgical manufactures advanced robotic surgical systems. Their da Vinci Xi system enables surgeons to perform minimally invasive procedures, including complex cardiac surgeries, offering precise control and enhanced visualization for medical professionals.

HeartBeam, Inc. develops and manufactures innovative medical devices for cardiac condition detection and monitoring. Their FDA-cleared, cable-free device collects 3D ECG signals, synthesizing a 12-lead ECG for at-home arrhythmia assessment. This portable platform enables remote cardiac health management, transforming patient care outside traditional medical facilities.

Based in New York, NY, Jarvik Heart, Inc. specializes in the development and manufacturing of miniature heart assist devices, including left ventricular assist devices (LVADs). The company's technology includes wirelessly charged heart pumps designed for infants and children, addressing critical cardiac support needs.

Kestra Medical Technologies, Inc. is a wearable medical device company developing diagnostic and therapeutic technologies for cardiac patients. They focus on innovative, intuitive solutions leveraging digital healthcare, smart wearables, and mobile connectivity to protect at-risk patients.

Laza Medical develops advanced imaging technologies and systems designed to support cardiac procedures. The company leverages expertise in medical robotics, imaging, and artificial intelligence to innovate new solutions, focusing on enhancing the precision and effectiveness of cardiac interventions.

LeeMAH Electronics, based in California, is a custom contract manufacturer providing electronic manufacturing services (EMS) for the medical device industry. They offer end-to-end solutions, including printed circuit board assembly (PCBA), cable assembly, box build manufacturing, and comprehensive testing services.

MicroPort, based in Memphis, TN, develops and manufactures innovative medical devices and technologies. The company specializes in solutions for diagnosing and treating cardiac rhythm disorders, offering a range of cardiac pacemakers and implantable devices.

Nventric, Inc. provides medical device design, development, and contract manufacturing for the Neurovascular, Electrophysiology, and Coronary markets. Capabilities include cardiac devices like drug-eluting stents, balloon catheters, and ablation catheters, offering innovative solutions for vascular disease treatment.

Prevailing Medical, a Minneapolis, MN-based contract medical device manufacturer, specializes in complex catheter design and development. They focus on electrophysiology EP, steerable, balloon, and sensor mapping catheters. Operating a 24,000 sq ft facility with a certified cleanroom ensures high-integrity device production.

Based in Diamond Bar, CA, QT Medical, Inc. develops and manufactures innovative 12-lead resting ECG systems. Their offerings include the PCA 500® recorder, QHeart® single-use pre-positioned sensors, and a mobile ECG app, simplifying testing and improving accuracy for professional remote care, urgent care, and clinics.

Reprieve Cardiovascular develops the Reprieve System, an intelligent decongestion management solution for Acute Decompensated Heart Failure patients. This automated fluid management technology aims to revolutionize care and improve patient outcomes.

Spaulding Medical is a cardiovascular device company that provides patients with immediate computer-interpreted ECG results. They offer a device catalog and solutions for taking ECGs in-home, focusing on accessible and accurate cardiac diagnostic technology.

Surge Cardiovascular is an ISO 13485 certified medical device manufacturer based in Grand Rapids, MI. The company specializes in innovative products designed for progressive cardiac care professionals, enhancing the surgical suite. They address the unique needs of demanding medical environments with advanced cardiovascular solutions.

Based in Tucson, AZ, SynCardia manufactures the SynCardia Total Artificial Heart (STAH). As the first and only commercially available replacement, their device is designed to fully replicate human heart functions, offering a vital solution for patients with end-stage heart failure.

Terumo Cardiovascular Systems manufactures advanced medical devices. The company specializes in developing robust, customizable perfusion management systems, ensuring reliable and consistent performance for cardiac procedures. These systems are designed to enhance patient safety and reduce risks during complex cardiovascular interventions.

Terumo Medical Corporation, based in Elkton, MD, manufactures a broad range of medical devices and supplies. The company performs research and development, manufacturing, and marketing of advanced cardiovascular products including guidewires, catheters, and interventional systems for cardiac care.

Based in Newport Beach, CA, TriFlo Cardiovascular Inc. is a biomedical company specializing in innovative cardiac device manufacturing. They develop and produce transcatheter systems to treat tricuspid valve regurgitation, featuring their unique Tricuspid Flow Optimizer implantable device with polymer leaflets. The company focuses on improving outcomes through minimally invasive solutions.

ZOLL Medical Corporation provides innovative medical devices and solutions for emergency care and cardiac resuscitation. The company manufactures products such as the LifeVest wearable defibrillator, designed to protect patients at risk of sudden cardiac death. ZOLL supports medical professionals across the continuum of care.

Based in Johns Creek, GA, Zywie Healthcare specializes in remote cardiac monitoring. They develop wearable heart monitors and cardiac devices, collecting crucial ECG data for healthcare providers and patients. Zywie's advanced analytics simplify access to health insights, optimizing treatment plans and improving patient outcomes.

Based in Waukegan, IL, Paragon Medical specializes in custom manufacturing and engineering for medical device components. The company provides cable assemblies, interconnect, and assembly solutions for various medical sectors including cardiac rhythm management, electrophysiology, and neuromodulation, utilizing materials such as Nitinol, PEEK, stainless steel, and silicone.

Based in Los Angeles, CA, Artivion, Inc. develops and manufactures advanced aortic technologies and cardiac devices. They provide innovative solutions for cardiac and vascular surgeons treating diseases of the aorta, including the AMDS Hybrid Prosthesis for aortic dissections and the On-X Aortic Heart Valve.

Based in Boston, MA, Autus Valve Technologies, Inc. is a medical device company developing the Autus Valve, a novel synthetic size-adjustable surgical pulmonary valve replacement for pediatric patients. This biomimetic, bileaflet device is designed to be balloon expanded transcatheter as the patient grows.

Based in Huntington Beach, CA, BiVACOR, Inc. is a clinical-stage medical device company specializing in the development of cardiac devices. They are pioneering the BiVACOR Total Artificial Heart (TAH), an FDA-approved solution for end-stage biventricular heart failure patients awaiting transplant, with an ongoing first-in-human Early Feasibility Study.

Based in Santa Cruz, CA, Capstan Medical specializes in transforming structural heart disease treatment. The company merges surgical robotics with catheter-based technology to develop next-generation heart valve implants. They aim to provide significantly less invasive alternatives for heart valve repair and replacement, currently for clinical investigation use.

Cardiosense manufactures medical-grade wearable cardiac devices, including the multimodal CardioTag™ Sensor. This technology integrates AI to analyze physiological signals, detecting early signs of cardiac disease. Their platform provides digital biomarkers and actionable clinical insights, enabling personalized patient therapy and improved outcomes.

Abbott manufactures a comprehensive range of cardiac devices in the United States. Their offerings include insertable cardiac monitors, advanced heart valve repair and replacement systems, ablation catheters, pacemakers, and various stents. They also produce heart pumps, contributing significantly to cardiovascular health technologies.

CobiCure MedTech is a nonprofit dedicated to reimagining pediatric medical device development. They specialize in creating novel solutions for pediatric cardiology, addressing the critical need for purpose-built devices for congenital heart defects. The company aims to reduce off-label use and accelerate innovation, especially for neonates and infants.

Johnson & Johnson, through its Biosense Webster division, manufactures advanced electro-anatomical mapping systems, like the CARTO ELEVATE™ Module, for catheter ablation procedures. These devices are critical for treating cardiac rhythm disorders. The company also focuses on broader cardiovascular health, innovating for heart failure recovery.

Laguna Tech USA is a medical device company located in Irvine, California. It specializes in developing transcatheter heart valves, including the ZETA Balloon Expandable Aortic Valve. This innovative system is designed for simple, reliable, and accurate deployment to treat aortic regurgitation and stenosis, featuring an easy-to-use delivery system.

LivaNova is a global medical device company that develops and manufactures neuromodulation devices and cardiopulmonary products. The company focuses on improving patient lives worldwide through innovation, maintaining a sustainable business, and ensuring product safety. They are dedicated to creating impactful medical technologies.

Medtronic is a direct manufacturer of advanced cardiac devices, offering a variety of pacemaker options designed to address diverse heart health situations. The company provides essential medical technology, collaborating with healthcare professionals to determine optimal solutions for patients.

Procyrion develops the Aortix™ percutaneous mechanical circulatory support (pMCS) device, designed for heart failure patients too sick for medication alone. Their dedicated team of specialists and engineers focuses on addressing unmet clinical needs through the development of this innovative cardiac support device.

Based in Wilmington, DE, P&F Products & Features is a medical technology company specializing in minimally invasive structural heart devices. The company develops cutting-edge technologies, such as the TricValve® system for severe tricuspid regurgitation, to transform structural heart condition treatment and improve patient outcomes globally.

Based in Valencia, CA, Sensydia develops and manufactures the Cardiac Performance System (CPS). This non-invasive platform accurately measures hemodynamic metrics such as Ejection Fraction (FDA approved 2018), Cardiac Output, and Pulmonary Artery Pressure. The system facilitates rapid, point-of-care assessment for critical care and heart failure patients, advancing cardiovascular care.

Based in Los Gatos, CA, Supira Medical is a clinical-stage company dedicated to advancing cardiac device technology. They specialize in the development of next-generation percutaneous ventricular assist devices (pVADs), aiming to provide innovative solutions for high-risk cardiac patients.

Tioga Cardiovascular specializes in the development and design of transcatheter mitral valve replacement (TMVR) systems. Based in Los Gatos, CA, the company focuses on innovative valve and anchor designs to treat a broader range of patients with mitral regurgitation, offering advanced solutions for cardiac care.

Terumo Interventional Systems develops and provides a comprehensive portfolio of interventional cardiology products. These advanced medical devices are designed for diagnosing and effectively treating various coronary artery diseases, supporting healthcare professionals with critical solutions for patient care.

Based in San Jose, CA, Vantis Vascular develops innovative medical devices. The company focuses on creating solutions for vascular interventionalists, enabling them to confidently, safely, and efficiently treat complex cases.

AngioDynamics, based in Latham, NY, develops and manufactures innovative medical devices for vascular interventions and oncology. They provide solutions for restoring healthy blood flow, including systems for peripheral arterial disease, deep vein thrombosis, and aspiration thrombectomy from the right heart, improving patient quality of life.

AtriCure designs, develops, and manufactures innovative medical devices for cardiac treatment. The company specializes in providing atrial fibrillation (Afib) treatment solutions, including the AtriClip device for left atrial appendage management (LAAM) and various surgical ablation therapies for commercial medical use.

Avive manufactures the Avive Connect AED®, an innovative automated external defibrillator system. It features Wi-Fi, cellular, and GPS connectivity, enabling direct 911 integration and rapid incident data transfer for out-of-hospital cardiac arrest response. Avive partners with communities to deploy comprehensive connected systems.

Based in Minneapolis, MN, CVRx develops and manufactures the Barostim neuromodulation device. This implantable cardiac device treats heart failure by delivering gentle electrical pulses to baroreceptors. It enhances signals to the brain, reducing stress and improving patient outcomes and quality of life.

Based in Lake Oswego, OR, Biotronik is a medical device manufacturer specializing in solutions for heart diseases and chronic pain. The company develops and produces cardiac rhythm management devices, including pacemakers and advanced DX ICD systems, to improve the diagnosis, treatment, and prevention of cardiovascular conditions.

Boston Scientific is a medical technology leader specializing in innovative solutions that transform patients' lives. The company provides advanced pacemaker technology, including respiration-based pacing, alongside other cutting-edge medical devices.

Based in Eagan, MN, Encore Medical manufactures transcatheter heart defect closure devices. The company specializes in patented PFO and ASD closure devices, designed to safely and effectively close cardiac defects. This technology prevents clots and reduces the risk of embolic stroke.

FARAPULSE provides an advanced Pulsed Field Ablation (PFA) system for minimally invasive cardiac ablation procedures. This technology utilizes quick pulses of electrical energy to precisely target and treat irregular heartbeats, specifically Atrial Fibrillation (AFib). The FARAPULSE PFA solution effectively restores healthy heart rhythm.

LeMaitre specializes in providing game-changing vascular surgery solutions. Since 1983, the company has focused on developing innovative devices and technologies for vascular procedures, supporting healthcare professionals with advanced tools to improve patient outcomes in cardiovascular care.

Reflow Medical is a US-based company specializing in the research, design, and engineering of high-performance medical devices. They partner with physicians to develop innovative solutions for unmet clinical needs in cardiovascular disease, focusing on products for Peripheral Artery Disease (PAD) and Coronary Artery Disease (CAD).

The WATCHMAN Implant is an FDA-approved, minimally invasive, one-time cardiac device designed to reduce stroke risk in people with non-valvular atrial fibrillation (AFib). It provides an alternative to lifelong blood thinners, with over 600,000 successful implants.

Bracco is a global healthcare group specializing in diagnostic imaging. Its subsidiary, ACIST Medical Systems, is a market leader in diagnostic and interventional cardiology, providing medical devices and systems for cardiovascular procedures. Bracco also develops and distributes contrast agents like AiMIFY and gadopiclenol.

Based in Irvine, CA, HighLife Medical develops and manufactures innovative transcatheter mitral valve replacement (TMVR) solutions. Their HighLife TSMVR system addresses moderate to severe mitral regurgitation, holding CE Mark approval and US FDA Breakthrough Device Designation.

iRhythm Technologies provides comprehensive cardiac monitoring services through its Zio® ECG monitors. These easy-to-wear devices capture critical heartbeat data, assisting doctors in detecting various cardiac conditions. The company's end-to-end service model emphasizes outstanding patient compliance and exceptional accuracy in cardiac monitoring solutions.

J&J MedTech US develops and manufactures advanced cardiac devices for the treatment of arrhythmia. With over 30 years of expertise in medical technology, the company provides innovative solutions for cardiovascular care. They are a prominent provider of products designed to improve patient outcomes.

Based in San Diego, CA, MaxWell Biomedical develops advanced cardiac devices. Their Rhythm360 AI-powered Cardiac Resynchronization Therapy for the Atrium (CRT-A) is designed to restore both atrial rhythm and mechanical function for patients with atrial fibrillation and heart failure.

Based in Newport Beach, CA, Renata Medical specializes in pediatric congenital heart disease innovation. The company manufactures the Minima Stent System, a first-of-its-kind, FDA-approved stent designed and tailored for treating vascular stenosis in neonates and infants. They focus on improving cardiac care for the youngest patients.

Based in San Diego, CA, Starlight Cardiovascular specializes in developing a portfolio of medical devices for babies born with Congenital Heart Disease. The company's mission is focused on healing little hearts by providing innovative cardiac solutions for pediatric patients.

Stereotaxis specializes in pioneering endovascular robotics, manufacturing the Genesis RMN System. This Robotic Magnetic Navigation System provides physicians with unprecedented responsiveness for various cardiac procedures, including advanced cardiac ablation.

Abbott Structural Heart develops and delivers a range of cardiac devices and therapies for structural heart conditions. The company provides heart solutions, including Transcatheter Edge-to-Edge Repair (TEER) systems like MitraClip and TriClip, TAVI systems, and LAAO programs, to improve patient quality of life.

Teleflex Medical OEM custom-engineers and manufactures complex catheters and medical device components for original equipment manufacturers. They offer comprehensive solutions from concept to commercialization, specializing in advanced extrusion, diagnostic, and interventional catheters. With multiple US manufacturing facilities, the company supports diverse medical device applications.