Frequently Asked Questions
Frequently Asked Questions
Hydrophilic coatings are common on medical devices. These coatings reduce procedure times by making it easier to thread a catheter through the vasculature during a minimally invasive surgery. Additionally, ISurGlide coatings reduce tissue damage during the passage of the device. These factors create better outcomes for the patient.
Many major medical device manufacturers in the US, Europe, and South America use ISurGlide coatings for their hydrophilic devices. ISurTec signs non-disclosure agreements as part of its licensing business model, so we cannot reveal the names of our customers. However, ISurGlide has been used on FDA-approved devices since 2007.
ISurGlide coatings feel very slippery when wet and lower the coefficient of friction from >1.0 for most medical device materials to < 0.05. You will be able to feel the difference our lubricious coating makes.
ISurGlide coatings range from 50 microns to less than 2 microns thick when hydrated. A typical coating is 5-10 microns thick when wet.
ISurGlide coatings are typically applied by a dip coating process followed by UV curing. The coating step can be incorporated into the customers in-line manufacturing or provided by a coating service company.
ISurTec provides research coating work on your medical device to demonstrate ISurGlide coatings but we do not provide coating services for human use.
The length of UV exposure is dependent on the intensity and wavelength of the UV light as well as the distance from the lamp to the device. These parameters need to be optimized for every unique device and coating machine. As a guideline, UV exposure lasts from 30 sec to 5 minutes UV cure time.
UV lamps should emit at wavelengths < 320 nm for the most efficient cure. Recommended UV lamps include broad-spectrum mercury metal halide lamps, single-wavelength fluorescent bulbs, and low-wavelength LEDs.
ISurGlide coating solutions are certified for use from 18 months to 2 years from the date of manufacture.
ISurGlide coating solutions are supplied in amber 1L bottles sealed with Teflon-coated lids. They can be stored at room temperature in ambient humidity conditions. ISurGlide coating solutions contain isopropanol and require flammable cabinets for safe storage.
ISurTec maintains an FDA masterfile on ISurGlide coatings and PhotoPrime primers. The FDA masterfile can be accessed by the FDA in support of licensed companies during the regulatory process.
ISurTec has tested ISurGlide coatings for biocompatibility per the short-term ISO 10993-1 biocompatibility panel including cytotoxicity, acute toxicity, irritation, sensitization, materials-mediated pyrogenicity and hemocompatibility. ISurGlide coatings were found biocompatible by this standard through testing at an external laboratory.
What is the standard process for obtaining an ISurGlide coating solution/how does ISurTec do business?
Upon contacting ISurTec, we will discuss your specific device needs with you. Depending on those needs, we will either offer to coat your device in-house to demonstrate ISurGlide coating or sell your company coating solution through a material transfer agreement. If the coating works well, a license/supplier agreement will be negotiated. ISurTec manufactures the coating solutions in house and will ship to your facility or to a coating service provider of your choice.
For further information, contact Patrick Guire at 651-209-9757 ext 11 or firstname.lastname@example.org.
ISurTec is a technology innovator with a deep passion for identifying, creating and commercializing new methods and products that enable companies to fulfill their mission.
Innovative Surface Technologies, Inc.
1045 Westgate Drive Suite 100
Saint Paul, MN 55114
ISurTec will consistently provide high quality products and services that meet requirements for medical device coatings and other scientific coatings. We will actively strive to bring excellence to the surface in all that we do, meeting or exceeding customers’ needs and expectations, and improve the quality of our products and service by enabling each employee to fulfill their job responsibilities correctly the first time.