Pulsed Field Ablation


Project: Pulsed Field Ablation

Client Need:

  • Innovative start-up developing pulsed field ablation (PFA) for therapeutic use in pulmonology
  • Software development and hardware/software integration for CE Marked system
  • Manufacturing of CE units for human clinical

How RBC Added Value:

This multiple phase project was initiated while the client was mid-way through project work with another contract manufacturer. RBC was contacted to aid in project rescue work to keep the client’s goals and timelines on track. RBC was able to transfer the design into its ISO 13485 Quality System and complete all development work to get the system completed and manufactured for US clinical study use. A parallel project was scoped for design verification and validation for the CE marked system, followed by a pilot phase. This included rebuilding and integrating software modifications and necessary product enclosure updates. RBC was also contracted through manufacturing for units to be used in European clinical studies.   

This client returned for a subsequent and unique development project that would assist them in determining viability to leverage platform technology across other applications.

Project: Pulsed Field Ablation

Client Need:

  • Pre-clinical prototype for pulsed field ablation to be used in prostate treatments
  • Development of initial proof of concept design for a bi-polar high-voltage pulse generator 

How RBC Added Value:

RBC was contacted to design and develop an RFIRE electroporation system to be used in pre-clinical investigation of therapeutic soft tissue destruction. The project required designing to specific characteristics for energy pulse waveform, frequency, duration and field strength. RBC also developed requirements for first generation commercialization. 

 

RBC’s speed of innovation, flexibility and dependability creates long term partnerships with our clients.
Learn more about RBC’s PFA capabilities

RBC has deep knowledge and extensive capabilities in Pulsed Field Ablation, spanning a variety of customers and indications. Utilizing the AdvantagePFA™ platform for rapid development, RBC can help bring your idea to market expediently. Learn more about RBC’s Acceleration platforms to help bring your idea to market expediently.

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