Parylene for Medical Device Coatings

Why Parylene for Medical Device Coatings?

History of Approval.

Parylene has been used as a medical device coating for over four decades and is FDA-approved with a USP XXII, Class VI biocompatibility rating. 3rd party test certificates available on request.

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Deposits as a Vapor.

Parylene film deposits one molecule at a time which enables parylene to coat intricate structures without pooling. Parylene is solvent-free, requires no curing and is deposited at room temperature.

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Sterilize on any Substrate.

Parylene can be used with all common sterilization methods: e-beam, gamma, ethylene oxide (EtO) and autoclave. Ask about VSi’s parylene type F for high temperature requirements.

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Next-Gen Material Properties.

Parylene’s unique material properties have allowed the medical device industry to advance innovative designs and find solutions for life saving technologies.

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Medical Device Coating Applications

Barrier Layer

Advanced Barrier Protection for Medical Devices

Parylene provides a uniform, ultra-thin barrier against moisture, bodily fluids, electrical interference, and contaminants—enhancing device reliability with minimal added material or stress on components. From long-term implants to single-use electronics, parylene ensures durability and performance across a wide range of medical devices.

Often used in:

  • Medical PCBs and sensors

  • Robotic Laparoscopic Devices

  • Cochlear Implants

  • Pacemakers and Implantable

  • Cardioverter Defibrillator (ICD)

  • Orthopedic Hardware: Pins And Screws

Parylene as a medical device coating used for barrier layer protection.

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Dielectric Layer

Precision Electrical Insulation for Medical Devices

Parylene provides a thin, uniform dielectric layer that insulates sensitive components, controlling current paths and preventing shorts or arcing. Its exceptional dielectric properties make it ideal for protecting electrically sensitive medical devices and ensuring reliable performance in critical applications.

Often used in:

  • Neurostimulation Devices

  • Ablation Devices

  • Electrodes

Parylene coating medical devices, Parylene Dielectric layer on medical devices

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Dry Lubricity

Friction Reduction for Smoother Device Operation

Parylene N creates a thin, dry-film lubricant that lowers friction, enhancing device control and reducing trauma to blood vessels. Offering a low coefficient of friction similar to PTFE (Teflon) but without PFAS, parylene provides a safer, more environmentally friendly alternative without the risk of harmful chemical exposure or long-term environmental impact.

Often used in:

  • Endoscopic Cables

  • Silicone Guide Tubes

  • Catheters

  • Power and Communication Cables

  • Mandrels

  • Guide Wires

Parylene coating medical devices, Parylene on Endoscope for dry lubricity

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Tie Layer

Tie Layer for Stronger Coating Adhesion

Parylene acts as a biocompatible primer, improving adhesion between medical devices and drug coatings or lubricious layers. It supports both hydrophilic and hydrophobic coatings without reacting with carrier polymers or drugs. Parylene is non-thrombogenic and does not trigger an immune response, making it ideal for implantable and blood-contacting devices.

Often used in:

  • Catheters

  • Balloon catheters

  • Guidewires

  • Stents

  • Needles

Parylene coating medical devices, Parylene as a drug adhesion tie layer on catheters and guide wires

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Why VSi?

VSi Parylene is Focused on the Medical Device Industry.

VSi meets all the necessary vendor approval requirements for regulated medical device manufacturing. What sets us apart, however, is our dedication to solving the challenges that help our customers bring life-saving products to market.

ISO 13485 Certified

And FDA 21 CFR 820 compliance ensures acceptance into your QMS.

Transparency

Open collaboration reduces risk and provides the best experience in parylene.

Clean Rooms

Multiple ISO class 7 (class 10,000)clean rooms for critical applications.

Development Partner

Custom process development and engineering; including qualifications (IQ, OQ, PQ) and PFMEA creation.

Pilot Lines

Facilitate pilot production for animal and human clinical trials. Validate process for commercialization.

Technology Transfer

Documented Work-Instructions with proprietary equipment lets you install process anywhere.

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