Integer Holdings Corporation, (Integer) operates as a medical device contract development and manufacturing organizations in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets.
As a strategic partner of choice to medical device companies and original equipment manufacturers (OEMs), the company is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company’s brands include Greatba...
Integer Holdings Corporation, (Integer) operates as a medical device contract development and manufacturing organizations in the world, serving the cardiac rhythm management, neuromodulation, and cardio and vascular markets.
As a strategic partner of choice to medical device companies and original equipment manufacturers (OEMs), the company is committed to enhancing the lives of patients worldwide by providing innovative, high-quality products and solutions. The company’s brands include Greatbatch Medical and Lake Region Medical. The company’s primary customers include large, multi-national OEMs and their affiliated subsidiaries.
Acquisitions and Divestitures
On October 31, 2024, the company completed the sale of the company wholly owned subsidiary Electrochem Solutions, Inc. (Electrochem), which focused on nonmedical applications for the energy, military and environmental sectors.
On January 5, 2024, the company acquired 100% of the outstanding capital stock of Pulse Technologies, Inc. (Pulse), a technology, engineering and contract manufacturing company focused on complex micro machining of medical device components for high growth structural heart, heart pump, electrophysiology, leadless pacing, and neuromodulation markets. Pulse also provides proprietary advanced technologies, including hierarchical surface restructuring (HSRTM), scratch-free surface finishes, and titanium nitride coatings.
As of October 1, 2023, the company acquired substantially all of the assets and assumed certain liabilities of InNeuroCo, Inc. (InNeuroCo), a privately held company based in Florida. A recognized leader in neurovascular catheter innovation with strong development and manufacturing capabilities, InNeuroCo’s expertise and highly differentiated neurovascular catheter innovation complements its existing capabilities and market focus, while further increasing the company’s ability to provide enhanced solutions to the company’s customers in the neurovascular catheter space.
On April 6, 2022, the company acquired 100% of the outstanding equity interests of Connemara Biomedical Holdings Teoranta, including its operating subsidiaries Aran Biomedical and Proxy Biomedical (collectively Aran). A recognized leader in proprietary medical textiles, high precision biomaterial coverings and coatings as well as advanced metal and polymer braiding, Aran delivers development and manufacturing solutions for implantable medical devices.
Segment and Product Lines
The company operated in two reportable segments: Medical and Non-Medical.
Cardio and Vascular
The Cardio and Vascular product line leverages a global footprint to produce a full range of components, subassemblies, and finished devices used in interventional cardiology, structural heart, heart failure, peripheral vascular, neurovascular, interventional oncology, electrophysiology, vascular access, infusion therapy, hemodialysis, urology, and gastroenterology procedures.
The following are the principal products and services offered by the company’s Cardio and Vascular product line:
Interventional Cardiology: The company’s interventional cardiology portfolio is focused primarily on the design, development and manufacture of catheter and wire-based technologies intended to diagnose and treat cardiac disease. Key products and capabilities span a full suite of devices including coronary stents, balloon catheters, atherectomy devices, imaging and sensing devices, chronic total occlusion solutions, percutaneous transluminal coronary angioplasty and access guidewires, introducer sheaths, and vascular closure devices. Core areas of technical expertise include laser-cut hypotubes, catheter shafts (extrusion, filmcast, and reflow), integrated hub assemblies, pad printing, tip shaping, polytetrafluoroethylene (PTFE) coating, complex machining, and sensor integration.
Structural Heart and Heart Failure: Structural heart and heart failure products include those used by cardiologists, echocardiographers, cardiac surgeons, and heart failure specialists to treat diseases or defects of the heart, such as valvular diseases and congenital defects. Integer provides components, subassemblies, and finished devices to these markets leveraging a wide range of technologies and capabilities. These include laser-cut and machined components, complex braided meshes, guidewires, introducer sheaths, steerable sheaths and delivery catheters, and implants used in transcatheter aortic valve replacement, balloon aortic valvuloplasty, transcatheter mitral valve repair and replacement, tricuspid mitral valve repair and replacement, atrial and defect closure, left ventricular assist, and shunt procedures.
Peripheral Vascular, Neurovascular, and Interventional Oncology: The company’s peripheral vascular, neurovascular, and interventional oncology portfolio is primarily focused on the design, development and manufacture of devices used during the treatment of peripheral artery disease, transcatheter embolization and occlusion, aortic aneurysm repair, and neurovascular stroke treatment. The company’s broad portfolio of devices, capabilities and technology platforms provides its customers with cost-effective, high-quality solutions ranging from device components to complex assemblies to finished devices such as regulatory approved guidewires and introducers.
Integer’s broad technology and capability portfolio within the peripheral vascular markets enables the company to address the full spectrum of devices needed in the diagnoses and treatment of peripheral vascular disease. In the peripheral artery disease markets, the company’s technologies are focused on the manufacture and development of interventional guidewires, support catheters, introducers and guiding sheaths, balloon catheters, self-expanding stents and stent grafts as well as embolic protection devices. The company’s neurovascular technology portfolio encompasses micro guidewires, micro and access catheters, aspiration catheters, stent retrievers, embolization coils, as well as flow diverters. In the interventional oncology market, it offers customers guidewires and microcatheters designed to enable the effective delivery of embolic agents.
Electrophysiology: Electrophysiology products include devices used by electrophysiologists and interventional cardiologists for the treatment of cardiac arrythmias, such as atrial fibrillation. Integer primarily produces devices used for the treatment of atrial fibrillation, the most prevalent cardiac arrythmia. These devices include sheaths and needles for transseptal access, diagnostic and mapping catheters to record and map the arrythmia sources, and ablation catheters to create lesions for blocking the arrythmia signals. Integer has the technical capabilities and expertise to provide the full spectrum of products from components to finished devices. Typical components include polyimide tubing, electrode rings, platinum tips and fine wires. Sub-assemblies include electrode ring and wire assemblies, steerable handle assemblies, and spline and basket assemblies. Finished devices include steerable transseptal sheaths, diagnostic catheters and ablation catheters.
Vascular Access, Infusion Therapy and Hemodialysis: The company’s solutions in these markets are focused on vessel access, treatment and device placement for medication and fluid delivery in patients with severe conditions requiring repeated vessel access. The company designs and manufactures a wide range of vascular access guidewires, stylets, catheters, valved / non-valved peelable and micro introducers. The company’s portfolio of market-ready vascular access guidewires and introducers kits enables a range of venous and arterial access applications, including transradial access. Additionally, the company supports customers with custom introducer sheaths and kit solutions leveraging its deep expertise in thin-wall sheath design, hydrophilic coatings and guidewire manufacturing (including poly-jacketed, mandrel, and nitinol core guidewire constructions).
Non-vascular Markets: Within the Cardio and Vascular product line, the company also manage non-vascular markets for which the company has expertise and offer a broad range of products, technologies and capabilities. Those markets include:
Urology: The company focus is in endourology for which it develops and manufactures finished devices and components for access and interventional devices such as guidewires, ureteral access sheaths, dilation devices, retrieval devices, ureteral stents, biopsy forceps, and endoscopes.
Gastroenterology: The company’s comprehensive range of technologies and capabilities enable te company to support its customers’ needs with a broad variety of products such as guidewires, dilatation devices, retrieval devices, snares, wire-formed and polymer stents, stent delivery systems, RF ablation devices, and endoscopes.
Cardiac Rhythm Management and Neuromodulation
The Cardiac Rhythm Management and Neuromodulation product line offers design, development and manufacturing capabilities for components, sub-assemblies, assemblies, and finished medical device systems. The company supports a variety of clinical markets, with an emphasis on the following markets:
Cardiac Rhythm Management: The cardiac rhythm management (CRM) market comprises implanted medical devices (IMDs), implanted leads, procedure accessories, as well as external devices that monitor and treat heart rhythm disorders and heart disease. Examples of CRM products include implantable pacemakers, implantable cardioverter defibrillators (ICDs), insertable cardiac monitors (ICMs), implantable cardiac pacing and defibrillation leads, and heart failure therapies such as ventricular assist devices and cardiac resynchronization devices (CRT-P and CRT-D). An IMD system generally includes an implantable pulse generator (IPG) and one or more stimulation leads. An IPG is a small battery powered device implanted under the skin in the chest that can sense and produce electrical pulses through specialized wires called leads. These leads sense electrical heart signals and carry them back to the IPG which in turn delivers electrical pulses back through the lead to the heart to deliver therapy.
The company’s portfolio of technologies and products include components, sub-assemblies, and assemblies for active IPGs, implanted sensing and stimulation leads, accessories, or external instruments. The company’s investments in research and development have created leadership positions in battery, capacitor, and feedthrough technology, including filtered feedthroughs.
The IPG, Integer’s CRM product line provides lead development and manufacturing solutions including expertise in low-polarization specialty-coated electrodes and components, and lead and device accessories such as stylets, guidewires, introducers, and lead adapters. Integer also offers fully designed and manufactured epicardial pacing leads.
Neuromodulation: Similar to the CRM market, the neuromodulation (Neuro) market comprises IPGs, implanted leads, procedure accessories, and external devices, such as battery chargers, trial stimulators and patient controllers. Examples of Neuro products include implantable spinal cord stimulators for chronic pain, sacral nerve stimulators for incontinence, deep brain stimulators for movement disorders and other IMDs to treat psychiatric disorders, sleep disorders and hearing loss. The Neuro market also includes several new emerging applications, such as implanted bioelectronic devices aimed at treating chronic diseases.
Within the Neuro market, the company offers IMD component technologies that have been developed to meet the needs of the company’s customers including its Xcellion line of lithium-ion rechargeable batteries, QMR and CFx non-rechargeable batteries, feedthroughs, device enclosures, machined components and lead components and sub-assemblies. Additionally, Integer helps OEMs and other emerging companies with the development and manufacture of complete neuromodulation IMD solutions, including custom IPGs, programmer systems, battery chargers, patient controllers, fully finished lead systems and accessories from initial development through commercial quantities.
Other Markets
The company provides a broad range of products and services to other markets such as minimally invasive surgery, general surgery, orthopedics, and Portable Medical. Other markets are areas where Integer is not strategically focused.
Portable Medical: The company’s offerings include customized rechargeable batteries and chargers to power medical devices across multiple clinical markets including patient monitoring, ventilators, portable defibrillators, portable ultrasound and X-Ray machines.
Customers
The company’s customers include large multi-national medical device OEMs and their subsidiaries. During 2024, three of its customers, Abbott Laboratories, Boston Scientific and Medtronic were each in excess of 10% of total sales and collectively accounted for 47% of the company’s total sales.
Sales and Marketing
The company sells its products directly to its customers, including large, multi-national OEMs and their affiliated subsidiaries.
Research and Product Development
The company’s RD&E expenses for 2024 is $53.4 million.
Patents and Proprietary Technology
As of December 31, 2024, the company owned 556 U.S. and foreign patents and have license right to another 159 patents.
Government Regulation
Integer develops, manufactures, markets and sells products in multiple countries throughout the world and is therefore subject to regulation by numerous agencies and legislative bodies, including the FDA, European Medicines Agency, Health Product Regulatory Agency, Health Canada, Therapeutics Goods Administration and other comparable foreign counterparts.
In the U.S., these regulations are enacted by the Federal Food, Drug and Cosmetic Act and its subsequent amendments, and the regulations issued or proposed thereunder.
The FDA’s Quality System Regulation sets forth basic quality requirements for the company’s sites that includes product design and manufacturing processes, requires the maintenance of certain records, and provides for on-site inspection of its facilities and continuing review by the FDA. Authorization to commercially market the company’s non-exempt products in the U.S. is granted by the FDA under procedures referred to as 510(k) pre-market notification or pre-market approval (PMA). These processes require the company to notify the FDA of the new product and obtain FDA clearance or approval before marketing the device.
The company is subject to Securities and Exchange Commission (SEC) rules adopted pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act concerning ‘conflict minerals’ (generally tin, tantalum, tungsten and gold) and similar rules are being implemented by the EU. It is also subject to disclosure requirements regarding abusive labor practices in portions of its supply chain under the California Transparency in Supply Chains Act and the U.K. Modern Slavery Act.
The company’s sales and marketing practices are subject to regulation by the U.S. Department of Health and Human Services pursuant to federal anti-kickback laws and are also subject to similar state laws.
History
The company was founded in 1970. The company was incorporated in 1997. The company was formerly known as Greatbatch, Inc. and changed its name to Integer Holdings Corporation in July 2016.