Properly designed mock vessels are a critical component of a successful pulsatile durability test for intravascular medical devices. Their geometry and mechanical properties play a key role in testing device deployment, apposition, loading, and inspections.
We have extensive experience in designing custom mock vessels for pulsatile fatigue testing and other test methods for devices such as stents, occluders, and heart valves. Through strategic relationships with silicone prototyping companies, we produce high grade, custom silicone models with fast turnaround time.
Designing silicone mock vessels
Element’s silicone mock vessels cover a wide variety of anatomical models that include bifurcations, aneurysms, valves, and other complex geometries. Straight, stepped, and U-shaped vessels are common geometries for mock vessels. We also provide standard models for iliac, aortic arch, and heart valve devices with a range of wall thicknesses.
The vessel’s tubing inner diameter and thickness are fully customizable, with typical inner diameters ranging from 1.5mm to 40mm and thicknesses from 0.25mm to 5mm or higher. Our partners can develop fibered, lubricious or sticky coatings for different applications and product requirements.
Silicone mock vessel compliance
ISO 7198 provides guidance for mock vessel compliance. Tube shape and thickness must be consistent throughout and meet customer specifications before testing occurs. The typical compliance range is 3%-7% per 100mmHg, and may be as high as 25% for some venous applications. Additionally, ASTM F2477 contains useful information on mock vessel selection, validation, and best practices for pulsatile durability testing. Learn more about mock vessel compliance validation in our Pulsatile Durability Testing of Complex Intravascular Devices article.
Our cardiovascular device experts follow well-developed protocols on mock vessel inspections, conditioning, and validation, and provide thorough documentation for each order. For more information about our silicone mock vessels, or to request a quote, contact our experts today.
International Organization for Standardization
Stent & Graft Testing
Element’s cardiovascular device experts offer a comprehensive suite of stent and graft testing including pulsatile durability, fatigue, visual inspection, and custom test methods.
ISO 10555 Catheter Testing
ISO 10555 outlines general requirements for testing intravascular sterile use catheters. We offer comprehensive testing services for catheters and balloons according to FDA guidance document recommendations and ISO standards.
Pulsatile Durability Testing of Complex Intravascular Devices
Designed to demonstrate the long-term integrity of devices under mechanical fatigue, pulsatile durability typically simulates ten years of post-implantation use under accelerated conditions.
Preconditioning Stents for Fatigue through Simulated Use Testing
Simulated use testing of implantable cardiovascular medical devices is a well-established non-clinical engineering test used to serve many purposes including delivery, deployment and retraction of a stent.