PROJECT: Renal RF Ablation System
High blood pressure is traditionally treated with pharmaceuticals. When this two-person company determined a new way of addressing this critical disease, they came to RBC with their brand new concept: A renal denervation device to treat chronic hypertension by ablating sympathetic nerve bundles using a basket catheter in the renal artery.
HOW RBC ADDED VALUE:
Using the AdvantageRF RF generator platform as a head start, RBC helped deliver the Renal RF Ablation System from blank sheet to approved product in 20 months.
From concept to commercialization in 20 months!
The client came to us with conceptual requirements for a flexible generator to implement their proprietary energy delivery algorithm. This energy would be delivered into a large number of electrodes in a very small basket catheter. They knew with AdvantageRF any combination of electrodes can be precisely controlled to create a unique ablation zone.
Starting with just a concept, RBC was instrumental in bringing this renal denervation system to market. During the project, RBC:
- Design: Designed and developed a spec-to-file product ready for CE certification
- Quality: Implemented and certified a quality system in the company including CE-marking the product
- Sourcing: Produced the entire supply chain including catheter developer/manufacturer
- Audits: Performed ISO audits
- Accessories: Created accessories including carts, stands, and extension cables
ASTONISHING SPEED TO MARKET
The Renal RF Ablation System effort is an excellent example of getting medical devices to market faster. We estimate use of the AdvantageRF from Energize Medical helped cut development from 36 months to 20 months.
By week 6, we were testing a rough prototype on different tissues.
By month 6, we were in pre-clinical studies using a form factor representative prototype of the device to deliver temperature controlled ablations.
A few clinical studies later, by month 14, we were in verfication, validation and certification.
By month 20, the CE mark was achieved for the Renal Ablation System, which is now saleable in the European market.
TECHNICAL AND DESIGN CHALLENGES
The client’s concept is an exciting innovation in the fight to control chronic hypertension. Bringing the Renal RF Ablation System required great collaboration and engineering ingenuity on all parts.
- The system drives 9 individual channels for ablation into 5F catheters.
- Temperature feedback shares the same line as the RF energy delivery.
- The system we built maximizes apposition inside the vessel to give optimal ablative zones pressing up against a circumferential area.
- With two electrodes on each spline, a large spread-out ablation can be delivered versus a single ablation area.
This project was a perfect fit for RBC Medical Innovations. The client, a two-person company at the time outsourced the design and development of a RF generator they needed in record time.