Parylene for Medical Device Coatings

What is parylene?

Parylene conformal coatings are ultra-thin, biocompatible polymer coatings.  Deposited as a vapor, parylene offers solutions for next-generation medical technology.

Learn more about the parylene coating process.

Benefits of using Parylene on Medical Devices

The combination of parylene’s advanced material properties and unique deposition process have long been beneficial for the life sciences. Parylene has helped advanced technology in cardiology, neurology, peripheral vascular, vascular access, urology, ophthalmology and other clinical markets.

History of Approval.

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

Learn More

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.

Learn More

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.

Learn More

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.

Learn More

Medical Applications

Tie Layer

Parylene promotes adhesion of drugs or lubricious coatings onto medical devices.

Parylene acts as a primer when it is applied between a device and a drug, hydrophilic or hydrophobic lubricious coating. Parylene provides unique bonding properties, exhibits nonthrombogenic properties and does not trigger an immunological response. Parylene is inert and does not react with the carrier polymers or drugs.

Often used in:

  • Catheters
  • Balloon catheters
  • Guidewires
  • Stents
  • Needles
Parylene as a drug adhesion tie layer on catheters and guide wires

Barrier Layer

Parylene protects medical devices from moisture, electrical charges, bodily fluids, and contamination.

Parylene is superior in terms of uniform coverage, barrier properties, less stress on mechanical structures, all with very little added material. These unique benefits make parylene an enabling solution for a wide range of medical device applications. Everything from encapsulating electronics in long term implants to improving the reliability in single use electronic 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 Barrier Layer

Dry Lubricity

Parylene lowers surface friction to  improve device control and reduce trauma to blood vessels for patients.

When parylene N is deposited in very thin layers, it acts as a dry-film lubricant. Parylene’s low coefficient of friction is comparable to PTFE (Teflon). Compared to PTFE, PVP and silicone parylene can be a better choice if flaking and particulates are a concern. Parylene outperforms spray and dip coatings when tight dimensional tolerances and complex geometries are involved, the device has heat sensitive materials or needs to be sterilized.

Often used in:

  • Endoscopic Cables
  • Silicone Guide Tubes
  • Catheters
  • Power and Communication Cables
  • Mandrels
Parylene on Endoscope for dry lubricity

Dielectric Layer

Parylene provides electrical insulation that controls the electrical current path and prevents arcing.

Parylene has excellent dielectric properties that are used to create a thin-film electrical insulation barrier. Medical device engineers use parylene to protect electrically sensitive components from shorts and arcing. Parylene is also be used in electrosurgical applications or control the area where current is exposed.

Often used in:

  • Neurostimulation Devices.
  • Electrostimulation Leads and Devices
  • Electrosurgery
  • Ablation Devices
  • Electrodes
Parylene Dielectric layer on medical devices

Why VSi?

VSi is Focused on the Medical Device Industry.

VSi checks all the boxes needed to comply with the vendor approval requirements for regulated medical device manufacturing. But what really separates VSi, is our passion for solving challenges that enable our customers to bring life-saving products to market.

About VSi

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.