Cirtec Medical

CIRTEC MEDICAL Your fully-integrated, full-service outsourcing partner for complex medical devices for over 30 years, Cirtec provides end-to-end product design, development and manufacturing of Class II and III medical devices and components. We specialize in today's most advanced product technologies including:

WORLD CLASS CAPABILITIES IN THREE DIVISIONS

Interventional
- Design and development services
- Finished device assembly
- Precision machined & stamped components
- Coil winding
- Laser welding
- Nitinol tubing/processing
Neuromodulation / Active Implants
- Design and development services
- Software, firmware, hardware
- Implantable Pulse Generators (IPG)
- ASIC design
- VAD
- Thin-flex circuits
- Leads, Cables, Connectors
- Patient controllers
- Precision machined & stamped components
Precision Components & Devices
- Application Specific Integrated Circuits (ASICs)
- Thin-film and flexible circuits
- Nitinol tubing
- Machining and Swiss turning
- Wire EDM
- Precision metal stamping
- Coil winding
- Hermetic welding and testing
- Laser marking, welding and cutting
- Silicone molding (HCR & LSR) and extrusion
- In-house EO sterilization

DESIGN & DEVELOPMENT Cirtec has the technical expertise needed to design innovative medical devices, solve complex design challenges and help bring your device to market. Our approach to product development enables us to design, test, validate and manufacture all the controls, electrical and mechanical parts within the most complex systems. Capabilities include:

Flexible and robust design control system
High concentration of engineers – 16%
Mechanical design
- SolidWorks
- Cosmos FEA
Electrical design
- Altium design software test system development
FDA compliant software design controls
FDA compliant human factors design controls
Packaging design
Rapid prototyping
- 3D printing
- In-house machining
- Engineering lab space
Design verification, process validation, and risk management activities

OUR FACILITIES:

Brooklyn Park, MN 1 – Corporate Headquarters

Facility core competences
- Nitinol Processing
- Nitinol Tubing Stock
- Laser Processing
- Precision machining
- Coil winding
- Cleanroom assembly
Typical markets
- Structural Heart and Vascular
- Neuromodulation
- MIS
- CRM
- Ophthalmology
Concept through commercialization capabilities

Brooklyn Park, MN (BP2) – Neuromodulation Center of Excellence

Facility core competences
- Manufacturing/assembly of leads
- Manufacturing/assembly of IPG’s
- Mechanical assemblies
Typical markets addressed
- Active implantable devices
Concept through commercialization capabilities
Risk mitigation facility

Brooklyn Park, MN (NovelCath) – Interventional Center of Excellence

Facility core competences
- Highly engineered catheter delivery systems
- Deflectable and steerable catheters
- Braiding
- Coiling
- Extrusion
- Tipping
- Prototyping lines
- Catheter assembly
Typical markets addressed
- Structural Heart
- Electrophysiology
- Neurovascular
Speed, Agility and Results

Los Gatos, CA – Design Center

Facility core competences
- Interventional device design and development
- VAD design and development
- EE/SW/Firmware design
- Mechanical engineering
- Rapid prototyping – 3D printing
Typical Markets Addressed
- Structural Heart and Vascular
- VAD
- Neuromodulation
Concept through commercialization capabilities
High mix / lower volume
Clinical builds
Low volume production

San Jose, CA - NovelCath (fka Cardea Catheter Innovations)

Facility core competences
- Braided and coiled catheter systems
- Deflectable and steerable catheters
- Multi-lumen/Multi-durometer designs
- Handle design
- PTCA/PTA balloons including semi-compliant and non-compliant
- Balloon catheter design and assembly
- Extrusions
- Catheter assembly
Typical markets addressed
- Structural Heart
- Electrophysiology
- Neurovascular

Santa Clara, CA – West Coast Center of Excellence for Catheters and Delivery Systems

Interventional Capabilities
- Catheter development
- Full device assembly
- Packaging
- Volume manufacturing
- Path to Cirtec Costa Rica production
Los Gatos facility will move into this location
- Interventional device design and development
- VAD design and development
- EE/SW/Firmware design
- Mechanical engineering
- Rapid prototyping – 3D printing

Enfield, CT - Active Implantable Design and Development

Facility core competences
- Active device development
- Mechanical engineering
- Commercial IPG production
- Mechanical engineering
- Welding / hermetic welding
- Packaging and EO sterilization
Typical markets addressed
- Neuromodulation
- VAD
- CRM
- Implantable drug pumps
Concept through commercialization capabilities
R&D lab development

Chandler, AZ

Full custom ASIC design
- Designed specifically for one application
- Produces significant power savings
- Key to miniaturization due to smaller batteries
- Enables higher level of integration, further reducing size and cost
Market experiences
- Implantable drug delivery IC’s
- Implantable peripheral nerve stimulator ICs
- Ingestible medical sensor IC
- Battery backup IC
Key markets
- Class III implantable medical device
- Battery powered portable electronics
- Power management applications

Lowell, MA

Thin-film and electroformed components
- Thin-film circuits
  - Single layer
  - Multi layer
- Flexible microcircuits
  - RF applications
  - Biosensor applications
- Precision electroforming
- Proprietary photolithography process
- Miniaturization
- SMT line
Key Markets
- Active medical device market
- RF/Microwave
- Optical applications

Sturtevant, WI – LSR Molding/Extrusion Center of Excellence

Rapid prototyping
Cleanroom molding (class 7 & 8)
ID/OD/Profile silicone extrusions – platinum and peroxide
Liquid injection molding/LSR
Liquid silicone rubber molding
Low volume transfer molding
Insert overmolding
Automated vision inspection
Data integration throughout manufacturing facility
Cryogenic de-flash
Ultrasonic wash
Coating applications
Pad printing
High volume cold runner
Assembly and sterile packaging
Implantable LSR
Full mold automation – including de-molding

Sturtevant, WI – Engineering Center

Quadra core competencies
- Design and Build of Prototype and Production for:
  - LSR hot runner
  - LSR cold runner – valve gated
  - HCR – low waste transfer - inserted flashless
  - Internal mold design
  - SolidWorks, SigmaSoft
- CNC machining centers capable of high volume runs for turning, milling
- Swiss lathes for ultra precise turning
- 5 axis CNC machining
- High precision surface grinders
- Internal mold repair for fast reaction and continuous improvement activities
- CMM inspection

Rock Hill, SC – HCR Molding Center of Excellence

Rapid prototyping
Molding: HCR wasteless/flashless
Core materials: Polyisoprene, Neoprene, Butyls, EPDMs, Silicones
Cryogenic de-flash and chlorination
Custom material development support, internal compounding & mixing
Tooling design
Dedicated in-house mold maintenance
FEA modeling and simulation
Data integration throughout plant
Automated vision inspection and automation
Analytical laboratory, FTIR, UV, DSC
Process validations
Precision slitting for flow control and slitting and die cutting

Birkenfeld, Germany – Vascotube – Precision Implantable Tubing

Facility core material
- Nitinol
- Cobalt-Chromium
- L-605
- Tantalum
- Titanium
- Magnesium
Typical markets addressed
- Minimally invasive interventional therapies
- Heart valves
- Peripheral vascular
- Neurovascular

Birkenfeld, Germany - Cirtec Medical Services GmbH

Continuous drawn tubing
Peripheral tubing
Nitinol processing

Coyol Free Zone, Costa Rica

Prime facility for line transfer business
Large-scale manufacturing site
Presence in Costa Rica’s major Med Device hub
Risk mitigation facility
Line transfers to-date:
- Catheter assembly line
- Client specific line
- Coil winding line
Capabilities:
- Coil winding
- Leads
- Device assembly
- Micro-Coiling

ADDITIONAL OFFICE LOCATIONS
Cirtec Medical – Los Gatos, 101 Cooper Court, Los Gatos, CA, 95032, United States, T (408) 395-0443, E [email protected]

ADDITIONAL OFFICE LOCATIONS
Vascotube A Cirtec Company, Birkenfeld, Goethestr. 38, 75217 Birkenfeld, Germany, T +49 7231 589 10 10, E [email protected]

ADDITIONAL OFFICE LOCATIONS
NovelCath a Cirtec Company, San Jose, 90 Great Oaks Blvd Suite 107, San Jose, CA, 95119, United States, T (408)385-7670, E [email protected]

ADDITIONAL OFFICE LOCATIONS
Cirtec Medical – Sturtevant, 1810 Renaissance Blvd, Sturtevant, WI, 53177, United States, T (262)417-1307, E [email protected]

ADDITIONAL OFFICE LOCATIONS
Cirtec Medical – Rock Hill, 663 Bryant Blvd, Rock Hill, SC, 29732, United States, T (803)366-7036, E [email protected]

Additional Offices

Cirtec Medical - Chandler 60 N. McClintock Dr. Suite #1 Chandler, AZ 85226 United States T 480.497.4511 E ASIC. [email protected]	Cirtec Medical - Costa Rica Edificio B11 Zona Franca Coyol Alajuela Alajuela Province Costa Rica E [email protected]
Cirtec Medical - Enfield 99 Print Shop Road Enfield, CT 06082 United States T 860.814.3900 F 860.394.1728 E [email protected]	Cirtec Medical - Los Gatos 101 Cooper Court Los Gatos, CA 95032 United States T 408.395.0443 E [email protected]
Cirtec Medical - Lowell 1001 Pawtucket Blvd Lowell, MA 01854 United States T 1.800.261.2557 E [email protected]	Cirtec/NovelCath (NC2) – Santa Clara 3301 Leonard Ct Santa Clara, CA 95054 United States T 408.353.6939 E [email protected]
NovelCath A Cirtec Company 8609 Xylon Ct N Brooklyn Park, MN 55445 United States T (763) 494-5551 E [email protected]