Overview of PFA Catheters
PFA is gradually gaining clinical acceptance due to its safety and other advantages associated with its cell-selective specificity. Some U.S. electrophysiologists believe that the use of PFA will increase from today’s 9% to more than 30% in the next year, and that PFA may soon become the dominant ablation technique for the treatment of atrial fibrillation. As advanced therapies like PFA continue to evolve, companies are increasingly relying on specialised partners to support complex device development and manufacturing. Learn more about what a medical device CDMO does
Companies developing PFA technology typically focus on voltage, electrode size, and other pulse parameters. But as with all active catheters, in addition to these key parameters, the overall design of the PFA catheter is very important and can be a substantial obstacle in the way of product development. Achieving this level of precision requires strong design foundations, particularly when applying design for manufacturability principles to ensure consistency and scalability. Learn more about design for manufacturability
In contrast to RF ablation catheters, which are highly versatile, PFA catheters come in a variety of catheter designs based on patient anatomy, such as Farapulse’s variable basket and petal shaped catheters.
Challenges Posed for Catheter Designing
This poses unprecedented challenges for both overall catheter design and process landing including:
- Stability of shaped catheter tip machining
- Stability of multi-electrode assembly
- Stability of wire and generator soldering
- Smoothness of head-end release and retraction
- The fit of the electrode to the inner wall after release
Rapid prototyping plays a key role in refining catheter designs and testing performance before moving into full-scale production. Learn more about medical device prototyping
Successfully scaling these designs into production requires a structured and controlled design transfer process. Explore medical device design transfer
Solutions Offered at Salt Medical
Salt has extensive experience in the design, development and manufacture of catheters for a wide range of interventional diagnostic and therapeutic applications. We have the ability to integrate a variety of diagnostic and therapeutic components such as precision braids and coils for catheter reinforcement, adjustable bend technology, and integrated intelligence platforms for delivery, diagnostics, and therapeutics to fulfil a wide range of clinical needs.
The Salt team has assisted a number of RF ablation, cryoablation, ultrasound ablation, and IVUS catheter customers with tasks such as transducer co-development and supply chain management, multi-lumen design and production, balloon capsule design and production, overall catheter design and production, and design and production of ancillary delivery systems.
Ongoing innovation in catheter technologies is also driven by continuous improvement across both design and manufacturing processes. Explore continuous improvement in medical device manufacturing
Contact us today to explore how partnering with us as your CDMO can benefit your organisation and discuss your specific requirements.
Discover more about catheter technologies and medical device development:
- Steerable Catheter Technology: Advancing Precision
- Advancing Intravascular Diagnosis and Treatment
- Flexible Electrode Balloon Catheters
- What is a Medical Device CDMO and Why Do You Need One?
- Design for Manufacturability in Medical Devices
- Medical Device Prototyping
- Medical Device Design Transfer
- Medical Device Design Validation
