Development and vertically integrated manufacturing of complex Class II and Class III medical devices from idea to series production.
Cirtec Medical
Brooklyn Park, MN (HQ) · Brooklyn Park, MN (Novelcath) · Enfield, CT · Chandler, AZ · Santa Clara, CA · Rock Hill, SC · Alajuela, Costa Rica · Birkenfeld (Vascotube), GermanyNew on Amplifa
About Cirtec Medical
Cirtec Medical is an end-to-end development partner for complex Class II and Class III medical devices, supporting OEMs and start-ups from concept through prototyping and regulatory approval to series production. The company actively manufactures implantable systems (IPGs, pacemakers, defibrillators, VADs), interventional catheter systems, microelectronics and thin-film circuits, neuromodulation leads, and precision components made of Nitinol, stainless steel, and MP35N. Processes include CNC and Swiss micro-machining, laser welding and cutting, extrusion, braiding, balloon forming, silicone and epoxy injection molding, SMT assembly, hermetic sealing, and Class 7 and 8 cleanroom assembly with in-house EO sterilization. Target markets are cardiology, electrophysiology, structural heart disease, neuromodulation, neurovascular interventions, orthopedics, diabetes care, drug delivery, and ophthalmology. With 11 locations in the USA, Costa Rica, and Germany – including Vascotube in Birkenfeld for Nitinol and MP35N components – Cirtec has more than 300,000 sq ft of production space, over 800 completed projects, and 22 PMA/IDE devices in ongoing production.
- Site
- Brooklyn Park, MN 55445
- Processes
- Advanced Catheter Technologies (Braiding, Balloon Forming, Electrode Integration), Silicone & Elastomers (Silicone processing for implants, drug delivery, tubing), Precision Metals (CNC Machining, Swiss Milling, Laser Processing), Advanced Electronics (Thin-Film Technology, Custom ASICs, Flexible Electronics), CNC and Swiss micro-machining for implant components, Laser welding, marking, cutting, and drilling, Metal Stamping (precision stamping) and secondary machining, Coil winding and assembly
- Materials
- Silicone, Synthetic Polyisoprene, Nitinol, Stainless Steel, MP35N, MP35NLT, FEP (Fluorinated Ethylene Propylene), Epoxy Resin
- Certificates
- ISO 13485:2016, FDA registered, ISO 14644 Class 7/8 Cleanroom
- Founded
- 1987
- Industries
- Medical Technology, Cardiology, Electrophysiology, Structural Heart Disease, Neuromodulation/Neurology, Neurovascular Interventions
- 01
Design & Development
- 02
Prototyping
- 03
Precision Component Manufacturing (CNC/Swiss, Laser, Stamping)
- 04
Extrusion, Braiding & Catheter Processing
- 05
Microelectronics & Thin-Film Assembly
- 06
Cleanroom Assembly (Class 7/8)
- 07
Sterilization & Packaging
- 08
Regulatory Support & Market Launch
Materials & Processes
Nitinol
Tubes and workable components for stents and catheter-based systems, including at Vascotube in Birkenfeld.
MP35N / MP35NLT
High-strength alloy for catheter reinforcements (braiding/coiling) and demanding medical components.
Stainless Steel
Material for catheter reinforcements, precision parts, and implant components.
Silicone
Elastomer for implants, drug delivery systems, and medical tubing with biocompatibility and flexibility.
Synthetic Polyisoprene
Elastomer for implantable devices and tubing applications.
FEP
Low-friction, biocompatible liners and heat shrink tubing for jacket bonding on catheters.
Epoxy Resin
Used in molding and backfilling for components of active implants.
Locations
Brooklyn Park 1 (HQ), MN
USHeadquarters; precision machining, laser processing, components for IPGs, catheters, and neurostimulation
- Materials
- Nitinol, Stainless Steel, MP35N
- CNC and Swiss micro-machining
- Laser welding/marking/cutting/drilling
- Stamping technology
- Coil winding
- Hermetic Sealing & Leak Testing
Brooklyn Park 2, MN
USDesign, development, and manufacturing of active implants; microelectronics & leads
- Microelectronics assembly
- Hermetic sealing
- Class 7/8 cleanrooms
- Sterile/non-sterile packaging
Brooklyn Park (Novelcath), MN
USElectrophysiology/ablation catheters, structural heart and neuro microcatheters
- Extrusion
- Tipping
- Catheter assembly
- Class 7 cleanroom
- R&D and prototyping
Enfield, CT
USDevelopment and manufacturing Class II/III, FDA registered
Chandler, AZ
USASIC/IC development and embedded systems for implantable devices
- Custom ASIC/ASSP development
- Mixed-signal/analog IC design
- IC evaluation boards
- Embedded software/firmware
Santa Clara, CA
USDevelopment and manufacturing Class II/III, FDA registered
Rock Hill, SC
USManufacturing, FDA registered
Alajuela (Coyol Free Zone), Costa Rica
CRHigh-volume manufacturing Class II/III with cleanroom and sterilization
- Lot size
- Clinical and commercial volume builds
- Class 7/8 cleanrooms
- In-house EO sterilization
- High-volume assembly of implantable and interventional devices
- Catheter assembly and packaging
Birkenfeld (Vascotube), Germany
DEComponents made of Nitinol and demanding materials such as MP35N/MP35NLT
- Materials
- Nitinol, MP35N, MP35NLT
Components & Systems
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Advanced Catheter Technologies (Braiding, Balloon Forming, Electrode Integration)Plastics | – | – | – | – | Silicone, Polyisoprene, Nitinol, Stainless Steel, MP35N, FEP |
| Silicone & Elastomers (Silicone processing for implants, drug delivery, tubing)Plastics | – | – | – | – | Silicone, Synthetic Polyisoprene |
| Precision Metals (CNC Machining, Swiss Milling, Laser Processing)Machining | micron-level precision | – | – | – | Nitinol, Stainless Steel, MP35N, MP35NLT |
| Advanced Electronics (Thin-Film Technology, Custom ASICs, Flexible Electronics)Assembly | – | – | – | – | – |
| CNC and Swiss micro-machining for implant componentsMachining | – | – | – | – | Metals |
| Laser welding, marking, cutting, and drillingJoining | – | – | – | – | Metals |
| Metal Stamping (precision stamping) and secondary machiningForming | – | – | – | – | Metals |
| Coil winding and assemblyAssembly | – | – | – | – | – |
| Hermetic sealing and leak testingTesting | – | – | – | – | – |
| Microelectronics assembly and hermetic sealing (ESD-safe environments, hermetic welding)Assembly | – | – | – | – | – |
| Manufacture of components for IPGs, catheters, and neurostimulation systemsAssembly | – | – | – | – | – |
| Complex deflectable and steerable catheters, braided and coiled reinforced shafts,Plastics | – | – | – | – | – |
| Extrusion (catheter extrusion)Plastics | – | – | – | – | – |
| Tipping (catheter tip manufacturing)Plastics | – | – | – | – | – |
| Catheter assembly and packaging (precision catheter assembly and packaging)Assembly | – | – | – | – | – |
| Custom ASIC and ASSP development, mixed-signal and analog IC design, neural sensing andEngineering | – | – | – | – | – |
| Nitinol tubes and processing (stents, catheter-based systems)Forming | – | – | – | – | Nitinol |
| Precision Swiss turning, wire EDM, and stampingMachining | – | – | – | – | Metals |
| Laser welding, marking, etching, and cuttingSurface | – | – | – | – | Metals |
| Silicone and epoxy resin injection molding (molding and backfilling)Plastics | – | – | – | – | Silicone, Epoxy Resin |
| Sterile and non-sterile packaging / sterilization management (in-house EO sterilization)Assembly | – | – | – | – | – |
| Cleanroom manufacturing (ISO Class 7 and Class 8 cleanrooms, ISO 14644)Assembly | – | – | – | – | – |
| Device Assembly (manual and automated assembly of complex medical devices)Assembly | – | – | – | – | – |
| Subassembly and secondary operations: precision welding and bonding, surface treatments,Heat Treatment | – | – | – | – | Metals |
| Thin Film and Flexible Circuits (ultra-miniaturized circuits, sensors, electrodes)Assembly | – | – | – | – | – |
| Leads Design & Manufacturing (paddle, percutaneous, and cuff leads for neuromodulation and cardiacAssembly | – | – | – | – | – |
| Active Implantable Devices (IPGs, Pacemakers, Defibrillators, VADs)Assembly | – | – | – | – | – |
| Complex medical extrusions for cardiovascular and neurovascularPlastics | – | – | – | – | – |
| Braiding & Coiling Reinforcement (reinforcement with Nitinol, stainless steel, or MP35N)Forming | – | – | – | – | Nitinol, Stainless Steel, MP35N |
| FEP Heat Shrink Tubing (FEP liners and heat shrink tubing)Plastics | – | – | – | – | FEP |
| Advanced Catheter Subassemblies (steerable multidirectional systems through microcatheters)Assembly | – | – | – | – | – |
| Catheter Electrode Rings (electrode rings)Assembly | – | – | – | – | – |
| Steerable Pull Rings (pull rings for catheters)Assembly | – | – | – | – | – |
| R&D and PrototypingEngineering | – | – | – | – | – |
| Research, Design & Development (end-to-end medical device development)Engineering | – | – | – | – | – |
| SMT Manufacturing (Surface Mount Technology assembly)Assembly | – | – | – | – | – |
| Testing and validation: functional testing, packaging and sterilization validation,Testing | – | – | – | – | – |
| Regulatory Support (510(k), PMA, CE marking, MDR/IVDR)Engineering | – | – | – | – | – |
| High-volume assembly of implantable and interventional devices (Costa Rica)Assembly | – | – | – | – | – |
| Medical devices made of Nitinol and demanding materials such as MP35N and MP35NLT (Vascotube,Forming | – | – | – | – | Nitinol, MP35N, MP35NLT |
Additional services
Reference customers
Quality & Regulatory
Cirtec operates with an ISO 13485:2016-certified QMS in FDA-registered facilities (21 CFR Part 820) and ISO 14644 Class 7/8 cleanrooms. In-house capabilities include functional, packaging, and sterilization validation, biocompatibility testing, IQ/OQ/PQ, in-process inspection, and eDHR-based traceability.
| Evidence | Brooklyn Park 1 | Brooklyn Park 2 | Novelcath | Enfield | Chandler | Alajuela (Costa Rica) | Birkenfeld (Vascotube) |
|---|---|---|---|---|---|---|---|
| ISO 13485:2016 | |||||||
| FDA registered | |||||||
| ISO 14644 Class 7/8 Cleanroom |
History
- 1987
Founding of Cirtec Medical.
- 2025
Steven Chevillotte was appointed to the Board of Directors in October.