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ATRAVERSE

RF GENERATOR

Atraverse partnered with Garrett Technologies, Inc. to develop a custom RF generator as part of its next-generation puncture system for left-heart access procedures. The project required integration with existing Hotwire/Hotwire Sidecar systems, a universal-voltage design, and future regulatory submissions in both U.S. and global markets. Garrett provided full-stack support, from requirements definition through transfer to pilot production.

Garrett's multidisciplinary engineering and regulatory leadership enabled Atraverse to accelerate development of a safe, intuitive, and compliant RF generator platform aligned with surgical workflow and global standards.

WE DELIVERED

  • Program management, system engineering, and planning

  • Design History File (DHF) creation and documentation

  • Requirements gathering and architecture definition

  • Integration with existing Atraverse catheter systems

  • Mechanical, electrical, and software engineering

  • Human factors and UI/UX design collaboration

  • Alpha prototype system builds and verification

  • Biocompatibility and toxicity evaluations (ISO 10993)

  • Disposable encryption and use tracking implementation

  • Preliminary EMC, FCC, environmental, and HALT testing

  • System verification protocol development and execution

  • Beta (DVT) unit build and verification

  • System testing with catheter/sheath variants

  • Agency testing support (FDA 510(k), CE mark preparation)

  • Full design transfer to manufacturing partners

  • First article inspection and pilot production support

  • Post-transfer documentation and 510(k) readiness