Advanced cardiovascular catheters are essential to treating life-threatening medical conditions. The global catheters market is expected to see a compound annual growth rate of 9.6% between 2022 and 2028. This is due in large part to rising rates of chronic cardiovascular conditions that require minimally invasive surgeries. As a result, medical equipment manufacturers are developing innovative catheters designed for delicate surgical procedures.
Many catheter suppliers are replacing traditional material solutions – including polyethylene, latex and silicone – with high-strength thermoplastic elastomers (TPE), such as polyether block amide (PEBA) sold as PEBAX® and VESTAMID®. In addition to being highly biocompatible, this material is kink-resistant, easy to sterilize and compatible with extrusion processes.
Yet, PEBA poses reliability issues in demanding catheter applications. The material absorbs moisture levels that may cause tubing to change dimensions or lose stiffness – making it more difficult to predict how final parts will perform in clinical environments. Manufacturing with PEBA also produces gel defects that create stress risers in thin-walled components and potential points of failure.
Selecting PEBA can also lead to quality issues during production. Catheter tubing made of the material tends to show high variation in extrusion behavior, which yields high scrap rates. High and low durometer PEBA grades tend to show varying levels of shrinkage, which can result in challenges gluing or welding together components of different sizes, hardness or materials. Due to its limited thermal stability, the material is not well-suited for manufacturing processes that require six or seven thermal events, or high-heat procedures such as cardiac ablation.
In 2020, recalls of 138,000 FDA Class 1 catheters impacted nine medical equipment suppliers in the United States alone. To protect and grow your business, you need to select a high-performance material that minimizes any risk to patients, enables you to reduce costs and is well-suited to catheter production processes.
A high-performance material solution you can trust
Envalior’s Arnitel® Care is specially engineered for manufacturing soft, durable medical devices that excel in high moisture and high-temperature conditions. The material combines high flexibility with the strength of rubber, due to its unique hard polyester and soft amorphous link structure. Key benefits for catheter manufacturers include:
- Compliance with FDA food contact, USP Class VI and ISO 10993-5/10 standards
- Stiffness tunable between 20 and 1000MPa for catheters with strict performance needs
- Extremely predictable extrusion behavior, ensuring high repeatability and reducing scrap
- Best-in-class snap back memory to prevent part deformation
- Outstanding thermal stability during assembly and in use
- Eliminates the risk of gel forming at bonding points
- High to low durometer grades that are easily welded and glued together
Due to the semi-crystalline hard blocks in its structure, Arnitel Care maintains excellent stiffness regardless of how much moisture its exposed to. Testing confirms that the material shows virtually no decrease in tensile strength after prolonged saturation in water – while PEBA shows significant plasticization in the same conditions. As a result, clinicians can be assured that Arnitel Care catheters will perform as expected throughout long, high-fluid surgical procedures.
Minimize the risk of recalls to give you peace of mind
Medical device malfunctions are frequently the result of lab testing data that doesn’t accurately predict how final parts will respond to real-life conditions. Envalior protects your reputation through comprehensive computer-aided engineering services that assess how catheter materials perform in high-stress clinical settings. Our virtual extrusion and weld line analysis tools accurately measure the fatigue lifetime of parts – enabling you to bring superior products to market faster.
At Envalior, we know that keeping patients safe is your first priority. Our commitment to helping you meet the healthcare industry’s needs is reflected by relationships with our customers – 97% of whom confirm that our materials consistently meet or exceed their expectations for quality. As we continue to enhance our portfolio of thermoplastic solutions for medical devices, we’re ready to partner with you to deliver advanced catheters that elevate the success of your business.
