Veriva PPSU – Comprehensive Overview

Veriva PPSU is a polyphenylsulfone polymer developed specifically for implantable medical devices that see prolonged or permanent exposure to bodily tissue and fluids. The thermoplastic resin is available in two colors: a transparent grade designated Veriva V-500 PPSU, and  white opaque version designated Veriva V-501 PPSU.

Veriva
Implantable Veriva PPSU machinable stock shapes are available from Genesis in transparent amber and opaque white.

What are Veriva PPSU Performance Benefits for Implantable Medical Devices

Veriva adds biocompatibility for permanent implantation to the inherent physical properties of PPSU, a material with decades of acceptance for short-term medical implant devices.  Its attributes include high structural strength, toughness, and compatibility with all common sterilization methods. Additionally, Veriva PPSU’s transparency and radiolucency facilitate CT, MRI, and x-ray procedures for implanted devices.

What is Veriva’s Regulatory Compliance for Biocompatibility?

Veriva PPSU resin is produced by Syensqo* in a dedicated facility that is cGMP-compliant and ISO 13485 certified. The material is tested in ISO 17025 accredited laboratories.  Regulatory approvals have been granted in the US, Europe and China. Support for MDMs includes access to the FDA Master File, Global Technical Files and ISO 10993:1 biocompatibility testing data (Table 1).  

Table 1: Veriva Implantable PPSU Biocompatibility Testing

What are Typical Implantable Device Applications for Veriva PPSU?

Veriva PPSU can easily withstand the pressures associated with implantable applications such as valves and shunts. This makes the high-performance polymer an excellent candidate for applications such as ventriculoperitoneal, ventriculoarterial and lumboperitoneal shunts for removing excess cerebrospinal fluid (CSF) from the central nervous system for the treatment of hydrocephalus and related conditions affecting the brain.

Genesis Medical Plastics Capabilities in Veriva Implantable PPSU

Genesis is ISO 13485:2016 and ISO 9001:2015 certified and FDA registered as a device manufacturing facility. Capabilities include prototyping, machining, injection molding and extrusion of semi-finished shapes.

Specifications –

SEMI-FINISHED SHAPES

Rod diameters – mm

  • 6.4mm – 152.4mm
  • Custom & larger diameters on request

Plate thicknesses

  • 6.4mm – 31.75mm
  • Larger thicknesses on request
  • Maximum width 610mm

All semi-finished shapes are made to order, with reasonable minimums.

Data Sheet

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