Based in Chicago, IL, Abbott specializes in the manufacturing of medical devices, including innovative stent technologies. The company is known for its fully dissolving Absorb stent, approved for the treatment of coronary artery disease. Abbott develops and provides advanced cardiovascular health solutions.
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Stent Manufacturers
Last updated: January 2026
This directory lists 65 stent manufacturers across the United States, from specialized Nitinol micro-machining houses to full-service contract manufacturers for complex drug-eluting stent systems.
Buyers in this space are often solving critical problems related to scaling production for a new cardiovascular or neurovascular device, seeking deep expertise in achieving precise radial strength and fatigue life for self-expanding stents, or navigating the intricate coating requirements for a new generation of drug-eluting stents (DES). The complexity of geometries and material science for implantable devices demands partners who truly understand the nuances.
Supplier types in this category vary significantly, encompassing dedicated contract manufacturers specializing in private-label stent fabrication, precision component manufacturers focused on laser-cut frames or braided structures, and integrated device manufacturers who can handle everything from design for manufacturability (DFM) to packaging and sterilization. Some specialize in specific materials like Nitinol or Cobalt-Chrome, while others offer broad expertise across various vascular and non-vascular applications.
Successful engagement requires buyers to arrive with detailed design files, comprehensive material specifications, explicit performance requirements—including anticipated crimpability, trackability, and deployment forces—and a clear understanding of their regulatory pathway. Manufacturers, in turn, expect a collaborative approach to design iterations, robust verification and validation protocols, and alignment on quality system requirements aligned with ISO 13485 and FDA 21 CFR Part 820.
A significant trend in stent manufacturing is the increasing demand for miniaturization for peripheral and neurovascular applications, pushing the boundaries of micro-laser cutting and advanced surface treatments like electropolishing. There's also a growing focus on bioresorbable scaffolds and next-generation drug-eluting coatings that offer enhanced biocompatibility and controlled elution kinetics, requiring manufacturers to continuously evolve their process capabilities and analytical testing.
Company Directory
65 companies nationwide
Based in Milpitas, CA, Elixir Medical is a company developing disruptive medical technologies for vascular interventions. They are re-imagining how these technologies will reshape vascular care, focusing on clinical evidence for products such as BIOADAPTOR and DESyne BDS Plus, indicative of stent development.
Based in San Marcos, CA, ACI Medical provides contract manufacturing and engineering services for medical devices. The company specializes in custom molding and miniature pumps, leveraging its expertise to produce medical device orders on time. They also develop their own vascular-related devices.
Advanced Bifurcation Systems is a Livermore, CA-based coronary medical device company. They specialize in developing FDA Class III medical devices, specifically engineered for challenging bifurcations within the coronary anatomy. The company focuses on innovative solutions for complex vascular interventions.
Based in Frisco, Texas, Argon Medical Devices manufactures specialty medical devices for interventionalists and specialists. The company develops and produces innovative products, including vascular stents and stent delivery systems. They provide solutions for peripheral intervention and drainage, utilizing advanced manufacturing capabilities to improve patient care.
Based in Highland Heights, OH, Norman Noble Inc. specializes in microprecision contract manufacturing for the medical device industry. They focus on Nitinol and other alloys, providing essential services for complex components like stents and other implantable devices.
Based in Columbus, OH, Battelle provides comprehensive medical device design, development, testing, and manufacturing services. Their experts support clients from concept through full-scale production, ensuring innovative and effective solutions across various therapeutic areas within the medical device industry.
BD is a prominent global medical technology company, directly providing the FDA-approved LifeStent™ Vascular Stent for vascular applications. They also offer a range of healthcare solutions, including connected care platforms, diagnostic systems, and services focused on advancing global health.
B. Braun Interventional Systems provides medical devices, specializing in interventional cardiology and radiology solutions. Their offerings include the NuDEL™ CP Stent® Delivery System, Occlutech® ASD Occluders, and Accel® all-purpose and biliary drainage catheter sets.
Based in Dublin, OH, Cordis, a Cardinal Health company, specializes in manufacturing advanced cardiology products. The company develops and produces innovative medical devices, including cobalt-chromium bare-metal stents (BMS) for cardiovascular applications, serving the medical industry.
Contego Medical develops and manufactures advanced medical devices for peripheral vascular interventions. Their flagship product, the Neuroguard IEP® System, is a 3-in-1 system combining a carotid stent, dilation balloon, and integrated embolic protection, designed for smarter, safer carotid stenting to prevent stroke and cognitive impairment.
Based in Bloomington, IN, Cook Medical is a family-owned medical device manufacturer specializing in minimally invasive procedures. The company invents and produces a unique portfolio of devices, including vascular stents. They collaborate with physicians to develop less invasive options, prominently featuring the Zilver® Vena™ Venous Self-Expanding Stent.
Based in Buffalo, NY, Nissha Medical Technologies specializes in end-to-end design, development, and contract manufacturing of complex single-use medical technologies. They offer innovative solutions, including Isometric Micro Molding Solutions and Accelerator Programs, to streamline product advancement and production efficiency for medical device customers.
Engineering By Design (EBD) provides manufacturing solutions for medical devices from San Jose, CA. Specializing in micro coil winding and catheter lamination, their processes include stent loading, stent crimping, and guidewire manufacturing. EBD also develops precision equipment for the medical device industry.
Edwards Lifesciences develops innovative patient-focused technologies for cardiovascular disease treatment, specializing in transcatheter heart valves and mitral and tricuspid technologies. They also provide surgical valve solutions and implantable devices for heart failure management, manufacturing advanced medical devices often incorporating stent technology.
Based in Chaska, MN, Formacoat provides advanced medical device contract manufacturing coating services. The company specializes in coating stents and catheters, offering a full spectrum of drug-eluting, biocompatible, hydrophilic, hydrophobic, and custom coatings. Their expertise spans formulation to sterilization, enhancing device performance.
Gore Medical is a manufacturer of advanced medical devices, including the GORE VIABIL Biliary Endoprosthesis. This fully covered self-expanding metal stent is designed for the palliation of malignant strictures in the biliary tree, showcasing their expertise in interventional medical solutions.
Infiniti Medical is a Fort Collins, CO-based manufacturer specializing in a wide range of veterinary stents and interventional radiology devices. They offer design and manufacturing services for bronchial, nasopharyngeal, trachea, caval, colonic, and esophageal stents, along with other solutions for companion animals.
Based in Eagan, MN, InSitu Technologies Inc. is a medical device company specializing in intra-vascular stents and cardiovascular products. They innovate stent technology, currently developing the Kauree™ Covered Stent. The company provides life-saving devices globally through a network spanning over 40 countries.
Integer Holdings Corporation, headquartered in Plano, TX, is a global medical device outsource manufacturer specializing in advanced medical device development. They produce standard and custom coronary stents, ensuring products meet stringent design requirements and functional demands for various medical applications.
Based in Minneapolis, MN, Coloplast Interventional Urology manufactures specialized medical devices. The company produces silicone hydro-coated double loop ureteral stents, designed for the drainage of the upper urinary tract. These stents are intended to address issues such as fistulas or ureteral obstacles, providing essential urological solutions.
Jupiter Endovascular develops and manufactures innovative endovascular therapies for cardiovascular diseases, including advanced stent-like devices. They focus on reimagining patient treatment for conditions like heart failure, leveraging engineering and biomedical expertise to deliver novel solutions.
Medical Murray is a contract manufacturer specializing in the design, development, and production of medical stents. They offer extensive experience with both metallic and polymer-based stents, serving the medical device industry. With facilities in North Barrington, IL, they provide comprehensive manufacturing solutions.
Based in South Jordan, UT, Merit Medical Systems, Inc. manufactures proprietary disposable medical devices for interventional, diagnostic, and therapeutic procedures. The company's Endoscopy division develops next-generation stent technology for airway and esophageal applications, serving client hospitals and physicians.
Based in Memphis, TN, MicroPort is a global medical device company providing solutions across twelve therapeutic areas. They specialize in high-quality medical devices and technologies, including cardiovascular and orthopedics, dedicated to improving lives worldwide through their innovations.
Boston Scientific is a medical technology leader that manufactures and launches a family of neurovascular stents in the U.S. and Europe. The company also develops and provides a range of medical therapies and devices, helping patients overcome conditions like cancer pain. It supports healthcare providers with advanced treatment solutions.
Norman Noble specializes in advanced manufacturing, machining, and finishing of medical devices. They offer laser processing capabilities for vascular nitinol stents, heart valve and neurovascular components. Additionally, they provide 5-axis micro milling for orthopedic implants, often creating custom manufacturing technologies for complex designs.
Norwood Medical, based in Dayton, OH, manufactures precision medtech innovations for demanding markets. Leveraging nearly a century of experience, they provide high-quality manufacturing services for cardiovascular, minimally invasive surgery, orthopedics, and robotic-assisted devices from their 700,000 square-foot campus.
Nventric, Inc. is a contract development and manufacturing organization (CDMO) specializing in end-to-end medical device solutions. They offer innovative design, development, and volume production for OEMs in the Neurovascular, Electrophysiology, and Coronary markets. Capabilities include manufacturing Drug Eluting Stents, revascularization, and ablation devices.
Based in Watertown, MN, Olexander R&D Inc. specializes in proprietary coating methods for neuro, coronary, and peripheral stents. They offer comprehensive coating services, including formulation (drug, polymer, solvent carrier), crimping, and sterilization, for both device manufacturers and academic institutions.
Based in Pepper Pike, OH, QMD provides end-to-end manufacturing for medical device OEMs, specializing in silicone and other elastomerics. Their services include precision components, custom subassemblies, device assembly, packaging, and sterilization. QMD develops coronary and peripheral vascular products, like PTCA, PTA, and aspiration catheters, with comprehensive regulatory approvals.
Based in San Diego, CA, REVA Medical develops and sells implantable bioresorbable medical devices for vascular applications. The company manufactures bioresorbable scaffolds, such as the MOTIV Bioresorbable Scaffold for peripheral artery disease and Fantom Encore for coronary arteries, using its proprietary Tyrocore™ polymer.
Roberson Machine Company provides precision CNC machining services, encompassing milling, turning, wire EDM, and 3D printing. Serving customers since 2002, they specialize in manufacturing components for diverse industries, including medical devices, oil & energy, and automotive. The company handles projects from prototype stages to full-scale production.
Based in Los Angeles, CA, TaeWoong Medical USA manufactures medical devices, specializing in gastrointestinal (GI) stents. They offer through-the-scope esophageal stents, engineered for precise deployment and enhanced patient comfort. The company provides innovative GI stent products and accessories, supporting healthcare professionals with advanced endoscopic solutions.
Terumo Medical Corporation is a prominent manufacturer providing medical solutions for cardiology, specializing in minimally invasive entry site management, lesion access, and therapeutic intervention. The company develops advanced devices and technologies to support cardiovascular care and improve patient outcomes.
Thoracent, Inc. specializes in providing pulmonary and thoracic medical products to the U.S. market. The company offers a range of stents, including their flagship BONASTENT tracheobronchial stent, Y-shaped tracheal stents, and various esophageal stents. They serve the medical sector with specialized devices for respiratory and digestive applications.
Based in Bridgeport, PA, Tube Methods, Inc. specializes in high precision tube manufacturing for demanding industries. The company produces cobalt cardiovascular stent tubing, providing critical components for medical clients. Their services include custom shapes, fabrication, and materials testing, supporting complex applications.
Micro-Tech Endoscopy is a medical technology company with over two decades of experience in manufacturing. It provides high-quality, affordable esophageal stent options, including fully covered and partially covered designs. The company focuses on physician-inspired innovations to enhance the effectiveness, safety, and potential of scope-based care, striving to make healthcare more value-driven.
Based in Laguna Hills, CA, Wallaby Medical is a medical device manufacturer specializing in advanced neurovascular intervention products. The company develops and globally launches innovative stent systems, such as the laser-cut, open-cell pEGASUS HPC Stent with antithrombogenic coating.
Advanced NanoTherapies engineers medical devices for cardiovascular health. They specialize in developing technologies for stent-like patency and restenosis prevention, using long-term release of two synergistic drugs. Their innovations deliver higher therapeutic potency with lower doses, aiming to enhance patient outcomes in stent applications.
Paragon Medical, with its brand Laserage, specializes in stent manufacturing for the medical device market. The company provides collaborative engineering and custom manufacturing of interconnect solutions and components. They serve major medical device OEMs across sectors like electrophysiology, neuromodulation, and peripheral vascular.
Based in Los Angeles, CA, Artivion, Inc. develops and manufactures advanced aortic technologies. The company provides innovative solutions for cardiac and vascular surgeons, including the AMDS Hybrid Prosthesis, an aortic arch remodeling device for acute aortic dissections, and the On-X Aortic Heart Valve.
Abbott Cardiovascular manufactures life-changing medical device technologies, specializing in solutions for treating cardiovascular conditions. They produce drug-eluting stents, including the XIENCE DES, known for performance even in complex cases.
Getinge is a global medical technology company specializing in solutions for operating rooms, intensive care, and sterile processing. The company provides equipment for cardiovascular procedures, including its iCast covered stents, alongside ventilation systems and surgical imaging solutions.
Medtronic manufactures and provides medical devices, specifically stent technologies for Percutaneous Coronary Intervention (PCI). They develop and offer a robust portfolio of stents designed to address the needs of patients in cardiovascular care.
Based in Sartell, MN, Revive Medical Technologies Inc. is a healthtech partner specializing in FDA-compliant medical-grade manufacturing of implantable devices. They offer end-to-end services including product design, development, testing, validation, regulatory strategy, and contract manufacturing for devices such as pacemakers, orthopedic implants, and stents.
Stryker is a global medical technology company advancing less invasive therapies for stroke treatment. They provide innovative products and services for both ischemic and hemorrhagic stroke, contributing to medical advancements in neurovascular care. Their offerings are integral to modern, less invasive medical procedures.
Based in Eastlake, OH, Astro Manufacturing & Design offers full-service contract manufacturing for the medical, aerospace, and military sectors. They specialize in large CNC machining, sheet metal fabrication, welding, automation, and integrated assembly of systems, machines, and sub-assemblies for complex applications.
ATEX Technologies designs and manufactures custom abdominal aortic stent grafts, combining self-expanding frames with precision-knit or woven textiles. This company focuses 100% on the medical device market, providing custom implantable components and medical textile solutions for various applications.
Confluent Medical specializes in expert design and manufacturing of interventional catheter-based devices and implants. The company offers material science technologies, Nitinol components, precision tubing, laser cutting, welding, and polymer stent coverings, bringing medical device designs to life through high-performance manufacturing.
Based in Newbury, OH, DEM Manufacturing is an FDA-registered, vertically integrated company specializing in medical device engineering, prototyping, and production. They provide turnkey product development, from design to high-precision manufacturing, applying Design for Manufacturing best practices for diverse medical device needs in the U.S.
Based in Poway, CA, Hobbs Medical manufactures and directly supplies plastic medical stents. Specializing in pancreo/biliary endotherapy, their MRI-safe stents provide essential devices for various medical procedures. They focus on high-quality, reliable solutions for healthcare providers.
Olympus America is a medical device company providing a wide range of high-quality ureteral stents and other endoprostheses. They offer diverse solutions for urological and biliary applications, ensuring high standards of quality and performance for patient care.
Based in San Clemente, CA, Reflow Medical designs and engineers high-performance medical devices, including the Spur Peripheral Retrievable Stent System. The company partners with physicians to develop innovative solutions for unmet clinical needs in cardiovascular disease, focusing on product concept through to patient outcomes.
Based in Fridley, MN, Resolution Medical provides comprehensive medical device manufacturing services. They specialize in complex delivery systems, active implantables, and component manufacturing, supporting trans-catheter devices made from Nitinol. Their capabilities span design, biosimulation, testing, and commercial production, partnering with OEMs and physicians.
Based in San Diego, Rev.1 Engineering is a medical device development company. It specializes in design and development, validation testing, and early-stage manufacturing. The company supports clients from concept to production with its expertise in various medical devices, including stent technologies.
Based in El Paso, TX, Seisa Medical is a full-service contract manufacturer specializing in Class II and Class III medical devices and specialty components. They offer end-to-end solutions, from design to packaging, for products including implantable stents. Utilizing high-quality nitinol, Seisa provides precision medical device manufacturing for its customers.
SMC Ltd. provides contract design, development, and manufacturing services for a range of medical devices. The company specializes in custom solutions for intricate surgical tools, advanced biopsy and injection devices, and other single-use medical devices. They also offer sterile filling and analytical services.
Based in Fairborn, OH, Tangible Solutions, Inc. is an ISO 13485:2016 certified and FDA registered 3D contract manufacturer. They specialize in medical devices, offering end-to-end services. Capabilities include additive manufacturing, 5-axis milling, and post-processing for high-quality implants and complex structures.
Based in Azusa, CA, Tecomet Etch offers precision chemical machining and etching services. They specialize in working with specialty metals like nitinol and titanium to produce components for implantable medical devices, including precision stents. Their services support prototyping to high-volume production.
VisionAir Solutions, based in Akron, OH, manufactures patient-specific silicone airway stents. The company leverages advanced 3D-printing technology and AI VisionAir 3D Stent Software to custom-develop personalized stents tailored to unique patient airway anatomies, improving quality of life for patients requiring such medical devices.
CERENOVUS, a part of the Johnson & Johnson MedTech family of healthcare companies, specializes in providing comprehensive solutions for stroke care. The company focuses on developing and manufacturing advanced medical devices, including neurovascular stents and related technologies, to address the needs of patients suffering from stroke.
Medinol Group designs and manufactures high-quality coronary and peripheral drug-eluting stents using innovative techniques and materials. The company focuses on improving patient outcomes in structural heart and stenting. Medinol operates with robust R&D, clinical trials, and a comprehensive quality management system.
Based in Newport Beach, CA, Renata Medical specializes in pediatric CHD innovation, developing and marketing solutions for infant vascular stenosis. The company manufactures the Minima Stent System, the only stent system designed, tested, and FDA approved specifically for infants.
Viant Medical partners with medical OEMs to design and manufacture advanced cardiac and interventional devices. The company provides comprehensive MedTech solutions, utilizing its expertise to solve complex design and manufacturing challenges for high-performance medical applications.
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How to Choose a Company
- Verify their specific expertise with your chosen material, whether it's Nitinol for superelasticity, Cobalt-Chrome for high radial strength, or Stainless Steel, and ensure they have validated processes for its unique fabrication (e.g., Nitinol shape-setting, laser cutting thin-walled tubing).
- Assess their quality management system (QMS) against ISO 13485 and FDA 21 CFR Part 820 requirements, demanding specific evidence of process validation (IQ/OQ/PQ) for critical steps like laser cutting, electropolishing, and heat treatment relevant to implantable medical devices.
- For Drug-Eluting Stents (DES), confirm their capabilities or established partnerships for precise polymer coating application, drug loading, and comprehensive in-vitro release testing to ensure coating integrity, stability, and controlled drug delivery.
- Evaluate their experience in Design for Manufacturability (DFM) specific to stent geometries, including cell design optimization, strut thickness, and link count, and how these choices impact crucial performance characteristics such as fatigue life, flexibility, and radial strength.
- Confirm their in-house testing capabilities for critical stent performance metrics, including but not limited to radial force, crimpability, pushability, trackability, and accelerated or real-time fatigue life testing, which are essential for regulatory submissions.
- Be wary of manufacturers who lack robust process validation (IQ/OQ/PQ) data or cannot demonstrate full traceability of raw materials and every manufacturing step for implantable devices. This indicates a critical gap in their quality system that could jeopardize regulatory approval and patient safety.
- Inquire about their experience with delivery system integration; a full-service partner should understand guidewire compatibility, balloon inflation (for balloon-expandable stents), and the nuances of precise stent deployment within a sheath.
Frequently Asked Questions
How do manufacturers ensure consistent crimpability and deployment for self-expanding Nitinol stents?
Consistent crimpability and reliable deployment for self-expanding Nitinol stents depend on precise thermal processing (shape-setting), accurate laser cutting of the frame, and meticulous electropolishing to create a smooth surface. Manufacturers achieve this through validated processes, strict control over material batches, and in-process testing of crucial parameters like radial force, deployment force, and recoil, often using specialized fixtures and deployment simulations.
What are the key regulatory certifications (e.g., ISO 13485, FDA 21 CFR Part 820) I should look for in a stent manufacturer, and why are they critical?
For implantable stents, ISO 13485 (Medical Devices Quality Management Systems) is paramount, demonstrating a commitment to quality and regulatory compliance. US-based manufacturers must also adhere to FDA 21 CFR Part 820 (Quality System Regulation). For global markets, CE Marking (Europe) and MDSAP (Medical Device Single Audit Program) compliance are vital. These certifications assure that the manufacturer's processes meet the stringent quality, safety, and traceability requirements essential for medical devices, directly impacting your product's regulatory approval.
What specific performance testing capabilities should a reputable stent manufacturer offer, especially for vascular applications?
A reputable stent manufacturer for vascular applications should offer comprehensive in-house testing, including radial force testing (both constrained and unconstrained), crimpability, trackability, pushability, and deployment force analysis. Critically, they must also provide robust fatigue life testing, often through accelerated pulsatile flow or bending tests, to simulate long-term in-vivo performance and ensure device durability in a dynamic physiological environment.
How does a manufacturer approach design for manufacturability (DFM) for complex stent geometries and specialized alloys like Nitinol?
A skilled manufacturer integrates DFM early in the design cycle by evaluating stent cell design, strut thickness, and overall geometry against their specific manufacturing capabilities (e.g., micro-laser cutting tolerances, electropolishing limitations). For Nitinol, DFM also focuses on optimizing shape-setting parameters, understanding the alloy's superelasticity, and managing residual stresses to ensure the desired radial force, fatigue life, and deployment characteristics are achieved consistently in production.
What's involved in the manufacturing process for a drug-eluting stent (DES) beyond the bare-metal frame?
Beyond the precision laser cutting and electropolishing of the bare-metal frame, manufacturing a drug-eluting stent (DES) involves intricate polymer coating application, precise drug loading, and often, a controlled drying or curing process. This requires specialized cleanroom environments, validated spraying or dipping techniques, and sophisticated analytical methods to verify coating thickness, uniformity, drug concentration, and controlled release kinetics. Biocompatibility and long-term stability of both the polymer and drug are paramount.
What is the typical lead time difference between prototyping and high-volume production for implantable stents?
Prototyping lead times for stents can range from 4-8 weeks for initial iterations, depending on design complexity and material. However, scaling to high-volume production for implantable stents involves significantly longer lead times, typically 6-12 months, or more. This accounts for extensive process validation (IQ/OQ/PQ), test method validation, acquiring specialized equipment, implementing robust quality controls, and securing long-term raw material supply chains, all under stringent regulatory requirements.