Nitinol & Stainless-steel Stents Manufacturing
One of the few European contract manufacturers offering dedicated Nitinol and stainless-steel wire stent production, from a purpose-built facility in Rødovre, Denmark.
~2,000
Stents per day estimated capacity on the Wafios FMU16+ alone, not at full speed
100%
Inspection of all welds as standard
ISO 8
Cleanroom capability at the end of the cleaning line
A dedicated facility
Separated from the CNC floor by design
Brüsch ApS is one of the few European contract manufacturers offering dedicated Nitinol and stainless-steel wire stent production, with a purpose-built facility on the Islevdalvej site in Rødovre, Denmark.
The stent production facility is housed in a separate building from the main CNC production floor, a deliberate decision, as CNC machining environments are inherently oil-rich and the cleanliness requirements for medical implant wire components demand a fundamentally different controlled environment. The facility operates under a regulated controlled environment, with ISO 8 cleanroom capability available at the end of the cleaning line where customer requirements demand it.
The facility is built around a Wafios FMU16+ wire forming machine, widely regarded as among the most precise wire processing equipment available, with the remainder of the production and cleaning setup custom-engineered specifically for Brüsch's stent manufacturing process, including a purpose-designed multimodule ultrasonic passivation and closed cleaning system.
Production process
A controlled, sequential flow
01
Wire sourcing
02
Wire bending
03
Welding
04
Heat setting
05
Electropolishing
06
Passivation
07
Ultrasonic cleaning in purified water (Ph. Eur.)
08
Final packaging
Each stage is documented and traceable, with 100% inspection of all welds performed as standard. Sampling inspection is conducted on every 20th component, including stress testing to verify mechanical integrity across the production run.
Materials
Two stent materials
Nitinol (nickel-titanium)
Wire stents produced in wire diameters from 0.05–0.30 mm, exploiting Nitinol's unique super elastic and shape-memory properties for minimally invasive cardiovascular and structural applications.
Stainless steel
Wire stents produced in wire diameters from 0.03–0.25 mm, offering high radial strength and established biocompatibility for a broad range of implant applications.
Brüsch has established a dedicated stent production facility, with qualification programmes currently underway across multiple medical device OEMs. The facility is production-ready and operating under full process control, in accordance with the requirements of ISO 13485:2016. Full material traceability, batch records and certification documentation are provided with every order.
Capabilities
More capabilities
CNC Equipment & Machinery
30 CNC production machines across sliding head turning, multitasking, milling and grinding, running 24-hour production.
Read more →Surface Finishing
Cylindrical grinding, honing, glass blasting and electropolishing for surfaces down to Ra 0.01 µm.
Read more →Cleaning, Assembly & Packaging
Validated cleaning, partial or full assembly and custom packaging integrated into the manufacturing flow.
Read more →Ready to discuss your next component?
Send your drawing or RFQ to sales@brusch.dk, and we'll make sure it reaches the right specialist.