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Internal Catheter Manufacturing Capabilities

Internal Catheter Manufacturing Capabilities

CathCAD™ Catheter Design Software
  • Allows the user to analyze and predict the mechanical characteristics of catheters. Aids in efficient translation of design inputs to performance outputs.

Carbon™ 3D Printing Additive Manufacturing
  • Catheter handles, internal gears, mechanisms, etc. Leverage specific FDA registered materials that are sterilizable and biocompatible allowing quick, iterative devlopment through to clinicals, low vol. manufacturing.

Injection Molding (With Integrated Mud-Base to Save Cost & Time)
  • Catheter components to lead components: Hubs, luers, implanatbles, handles, dilator tips, etc.

Braiding (16 & 32 Carrier Options Available) & Coiling
  • Metallic and non-metallic. Varying pic counts, braid patterns to hit specific catheter shaft performancce requirements (ex. torque, pushability)

Welding (Laser, Ultrasonic, Resistance, Glovebox), Soldering & Leak Testing
  • Pull-wires to distal anchor rings for steerability, marker band integration, etc.

 

  • Implantable Pulse Generator (IPG) (active/passive) internal component assembly & hermetic can sealing

Laser Cutting (Metal & Polymer)
  • Custom hypotubes for high performance catheters to hit specific catheter shaft performance requirements (ex. king resistance, torque, pushability) stent design, cannula formation, etc.

Tipping (RF)
  • Precise catheter tip shaping to optimize device transition, interactions, and trackability via low profile design.

Reflow (Vertical & Horizontal)
  • Multiple Grieve Ovens with latest custom model that can accommodate up to 6ft of length per catheter shaft.

Machine Shop
  • CNC, lathe used for creating precision, custom fixtures in rapid timeframe to support catheter prototyping and manufacturing.

Automated Inspection System
  • Zeiss O-Inspect provides speed and versatility with both optical & contact measurement to assure high quality & well-tolerated components.

Customized, Flexible, Electronic Quality System
  • Differentiates components from finished systems/devices

  • Feasability: proof of concept

  • Certificate of Analysis: process and material traceability maintained, product has not been fully evaluated for all print criteria (prototype)

  • Certificate of Conformance: product meets all requirements within the specification, plus process and material traceability maintained

Testing
  • Anatomical, pulsatile bench top models, track paths

  • Torque, dimensional, tensile, etc

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