The heart of the matter

Meeting demanding technical requirements

"Developing devices for these therapies requires meeting strict technical demands," says Don Bonitati, Americas Segment Director for Trelleborg’s medical solutions. "Catheters need to navigate the vascular system effectively, which means finding the right balance between flexibility and pushability."

Key functional specifications include low crossing force, dependable hemostasis to limit bleeding and compatibility with various device sizes. Hemostasis, the process of stopping blood flow, relies on advanced valve and seal designs, such as multi-layer membranes and precise geometries, to ensure both safety and performance.

The impact of advanced extrusion techniques

"Creating certain cardiovascular devices relies on advanced extrusion techniques," explains Bonitati. "Modern extrusion allows us to form complex, multifunctional components that support trends in device miniaturization and greater functionality."

"We extrude multi-lumen tubing with high precision to include multiple wires or channels. Technologies like variable cross-section extrusion remove the need for extra bonding steps, which results in stronger and more hygienic products," he adds. "Enhancements like colored striping, reinforcement braiding and co-extrusions open more doors for device development. These techniques help engineers meet changing medical needs and regulatory expectations."

Partnerships as a key to success

Tackling the complexities of cardiology device development often involves early collaboration between Trelleborg and its customers. Bonitati shares an example involving an original equipment manufacturer (OEM) that created a left ventricular assist device (LVAD), a Class III medical implant used by patients awaiting heart transplants. Scaling production for its complex subassemblies presented significant challenges.

Trelleborg provided expertise in materials, metal-silicone insert molding and extrusion to develop critical driveline components. Through close collaboration and a structured quality management process, Trelleborg supported efficient design improvements, scalable production and an on-time product launch. Additionally, Trelleborg ensured the device complied with the US FDA (Federal and Drug Administration) and the EU’s MDR (Medical Device Regulation) safety standards, from initial development through post-market monitoring.

Future advances in cardiology

"In the future, cardiology will likely continue advancing toward smaller, more integrated device designs using bioresorbable materials that reduce risk and improve long-term safety," says Bonitati. "Artificial intelligence will surely drive more improvements in diagnostics, patient monitoring and manufacturing efficiency."