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.
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 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.
Pulsed Field Ablation
AdvantagePFA™ Overview
The Advantage Platforms™ offer a menu of technologies and capabilities to give your innovation a competitive edge and expedite time to market
Pulsed field ablation is a tissue ablation technique that delivers electrical pulses to isolated, affected tissue to initiate cellular necrosis through a process commonly known as irreversible electroporation (IRE). This offers safe treatment without disturbing the surrounding tissues for further damage.
Serving the needs of our clients and their objectives to expand therapeutic applications of PFA, we’ve gained experience in pulmonology, cardiology, oncology and drug delivery. Introducing this therapy to new market segments requires an experienced partner to bring your concept to life in the fastest, most cost effective way possible.
Customize Your PFA System on Our Market-Proven Foundation
Pulmonary Health
Cardiac Health
Oncology
Drug Delivery
Have an ablation system design ready for prime time? Learn more about our contract manufacturing services today
Leverage established architecture designed for rapid customization
Leverage established architecture designed for rapid customization.
From concept to market – Expedite your design process without sacrificing quality. Here at RBC, we offer a deep knowledge in the extensive capabilities available within this platform spanning across a variety of customers and indications. Leveraging our AdvantagePFA™ Platform and other platform capabilities can get your technology to market 60% faster!
RBC has aided clients in multi-phase project rescues to ISO certify PFA systems for complete development and manufacturing. This included rebuilding and integrating complex software modification necessary for product enclosure updates and using this system in European clinical studies.
RBC was contacted to develop an electroporation system for pre-clinical investigations of therapeutic soft tissue destruction. This project required design specifications for energy pulse waveforms, frequency, duration, and field strength – RBC used this to develop requirements for first generation commercialization.
RBC’s speed of innovation, flexibility and dependability with our clients has created long-term partnerships that have led to the design and development of more life-changing technologies through this platform
Let’s connect to get your pulsed field ablation program in motion!
Our pre-existing base systems are customizable to match your vision.
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