Genesis Medical Plastics introduces implantable PEEK film

Genesis Medical Plastics has developed production-scale calendering to convert medical grade and implantable PEEK into thin sheet and film. The technology adds to the medical polymer conversion services it provides in injection moulding, extrusion of machinable shapes, and CNC machining.

PEEK (Polyetheretherketone) has seen exceptional growth in medical device applications. Unlike grades sold commercially, implantable PEEK is available to device manufacturers from polymer producers under restrictive conditions. Device manufacturers either process the polymer in-house or align with a medical polymer conversion specialist such as Genesis for production.

Genesis’ calendering operation converts implantable PEEK into thicknesses from 0.1mm to 1.0mm, in rolls, spools of strip, and custom-sized sheets. The film can be precision laser-cut or stamped into intricate configurations for implantable bioelectronic applications including connectors and components for defibrillators and pacemakers. Injection moulding and machining of stock shapes have been the prominent methods for producing implantable PEEK components. The lack of commercially available implant grade PEEK film and thin sheet has hampered advancements in medical devices. “Our investments in calendering for medical PEEK came in response to customers’ requests. Starting with FDA F2026 certified PEEK resin and hitting the necessary targets for reliable production with consistent thicknesses, physical properties and overall quality led us to engineer our own production equipment and process control systems,” said Stephen Kramer, General Manager.

“Genesis is a project-based conversion service for customers’ medical polymer formulations. Our mindset is about adapting or developing technology to deliver whatever customers need for their medical devices. With film calendering, we saw the development challenge as an opportunity to help our customers bring the proven benefits of implantable PEEK to more applications,” Kramer said.

Genesis Medical Plastics based in Cypress, Texas is an ISO 13485:2016 certified company and an FDA Class II registered medical device manufacturer.

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