As an integrated, single-source supplier, Vention was able to provide the critical components and services needed for this project in-house, accelerating the timeline. Team members at various facilities designed, developed, and manufactured the device under one quality system, saving significant time compared with working with a network of outside suppliers.
The team rapidly generated concepts and prototypes to demonstrate design feasibility in 6 weeks, providing proof-of-concept evidence for a key investor milestone.
One of the primary challenges was designing a 5 Fr catheter that could accommodate the complex array of electrodes and sensors required for multipoint ablation and real-time monitoring, while meeting all standards for electrical safety testing.
- Reinforced shafts:
- An inner, film-cast, braid-reinforced polyimide shaft for strength and flexibility
- A middle extruded layer with a complex geometric profile to provide connectivity to the electrodes and sensors
- An outer laminated, multidurometer thermoplastic shaft to provide structure and kink resistance
- PET heat-shrink tubing: This tubing was ideal to add strength at stress points and provide ultrathin insulation at electrical junctions
- Balloons: Drawing on its expertise in balloons, Vention devised an innovative means of increasing the efficiency of the RF energy delivered for treatment, while protecting the patient from excess RF energy
Vention strategically deployed team expertise for each stage of the project, engaging various technical leaders within the organization while maintaining continuity by focusing on key priorities and deliverables at each phase.
Throughout the project, the team operated within Vention’s Quality Management System and followed Vention's stage-gate process: Concept & Feasibility, Design & Development, Verification & Validation, and Manufacturing Transfer & Clinical Manufacturing.