About the material
- Expanded polytetrafluoroethylene (ePTFE)
- Flexible, biocompatible material
- Lubricity, strength and durability
- The ability to collapse and expand repeatedly is critical for use in vascular applications
- The material can cycle many times w/o breaking or coming off of the device - which makes it valuable in the stent deployment process and resistant to wear in the body.
- Varying permeability
- Material is easy to work with due to its temperature stability and achievable thinness.
- Internal and external layers of coating measure in microns - meaning while the structure is deployed, it enhances the ability to navigate the vasculature but does not add significant thickness or diameter to the primary device.
- Takes much longer, is more manual and costs exhorbentently more.
- Difficult to scale up in a manufacturing operation
Electrospinning/Wrapping (?) Difference?
- Our ePTFE covering can encapsulate complex geometries and have an extremely thin wall thickness (can be less than 0.001”)
- Covering technologies
- Suturing - time consuming, manual, less repetitive, harder to scale up. 1 layer of ePTFE the sutures create another mini layer and generate stress in the areas of the sutures - disadvantage for crimping profile.
- Lamination - can be laminated on ID, OD, or both. Uses temperature and pressure to connect the cover to the metallic scaffold - sandwich like - good for when thickness increase and crimping profile does not pose a problem
- Sintering - 2 layers of eptfe are sintered onto each other then adhered to the metal stent - process requires higher temperatures so more of an issue for the thermal propeties of the nitinol or metalic stent
Clinical Areas + Applications
- Valve Repair & Replacement
- Left Atrial Appendage (LAA) Implants
- Mitral Valve Clips
- Septal Occluders
Covering Testing Standards
We use our company's expertise and experience to manage all aspects of the testing your ePTFE-covered device requires - whether performed in-house or through our partners. Our testing services examine your device's conformity with standards and compatibility with appropriate accessories and fittings.
Cardiovascular implants — Endovascular device requirements
> Fatigue & Durability
> Fixation & Seal
> Migration Resistance
Tubular vascular grafts and vascular patches testing requirements
> Porosity (non-textile materials)
> Tensile Strength
> Suture Retention & Burst Strength
> Kink Diameter / Radius
> Preclinical In-Vivo