Metal replacement in medical device saves OEM production time and expense

Apollo Medical extruded plastic tubingApollo Medical Extrusion (Sandy, UT) typically presents polymers in its portfolio to medical device OEMs in terms of solutions, said Jonathan Jurgaitis, Senior Process Engineer. But the company is taking a different tack with the medical-grade Veradel polyethersulfone (PESU) from Solvay (Alpharetta, GA), which it recently added to its product line. It describes the material “as an idea generator.” The reason, explained Jurgaitis, is because it expands the design envelope for micro tubing used in catheter, endoscopy and laparoscopic instruments.

Apollo Medical Extrusion now offers single- and multi-lumen medical micro tubing extruded from Solvay’s medical-grade Veradel HC A-301 NT PESU. It is suited for applications that require a combination of rigidity, transparency and sterilization. “It’s stronger than polycarbonate, more transparent than PEI and it enables multi-lumen micro-tube configurations that stainless steel cannot achieve,” said Jurgaitis. He cited one customer who effectively replaced stainless steel tubing with a PESU alternative, boosting productivity and reducing cost in the process.

The customer had been cutting stainless steel tubes and welding them together again to fabricate a medical component. Apollo was able to extrude the final part from Veradel HC A-301 PESU in one step, saving the customer significant production time and expense.

“While PESU is not intended to replace stainless steel in structural components, it introduces more flexible design options in applications where specifying stainless steel might over-engineer the part,” said Jeff Hrivnak, Business Manager for Healthcare at Solvay’s Specialty Polymers global business unit. “The material’s high flow rate is well-suited for extruding thin-walled micro tubes with complex geometries, and it offers the highest stiffness of all of Solvay’s sulfone polymers. This helps explain why Solvay is seeing increasing interest in Veradel HC A-301 PESU’s potential for enabling game-changing new medical device designs.”

Solvay’s medical-grade PESU polymer has been tested under ISO 10993 biocompatibility standards for cytotoxicity, irritation and acute systemic toxicity, and it is compatible with steam sterilization and chemical sterilants. The company also provides a detailed FDA Master Access File (MAF) for the new material, along with additional regulatory support to help streamline customers’ time-to-market.

Solvay was also in the news recently when it introduced a 30% carbon-fiber-reinforced polyetheretherketone (PEEK) as part of its Solviva Biomaterials line for implantable device applications. The radiolucent Zeniva ZA-600 CF30 PEEK polymer features a modulus similar to cortical bone. Unlike implantable metals, the material can help implants minimize reduction in bone density by maintaining normal stress on surrounding bone tissue, according to Solvay. To learn more about this material, read “Solvay unveils high-strength, injection-moldable PEEK polymer for medical implantables.”

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