Medical Device Testing Services
Medical Device Testing Services
 

In Vitro Pulsatile Durability Testing:

Intravascular Devices  

Scope:

This benchtop test provides empirical evidence for the continued structural integrity of the devices when subjected to mechanical fatigue replicating in vivo conditions. The test is designed to simulate the device radial fatigue due to expansion and contraction of the surrounding vessel. Physiological strain of a healthy vessel at normal heart rate is first modeled using mock arteries implanted with the device. The test is then accelerated to obtain results in less time than physiological rates would allow. The test is conducted under simulated physiological conditions with saline at 37C.

Commonly tested devices include:

Objective:

The testing objective is to meet the requirements for in vitro mechanical fatigue testing stated in ASTM F2477-07 “Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents” as well as ISO 25539-1, 7198:1998, and 99128. The test demonstrates the integrity of the device under mechanical fatigue for a minimum of 10 years post-implantation. A device failure is defined by the device manufacturer (for example, any broken or cracked strut visible at 30x magnification during or at the end of the test). The device manufacturer will also examine the devices post-testing against the defined acceptance and/or failure criteria.

Equipment:

MDT uses ElectroForce 9100 Series Stent Testers which operate on the principle of fluid displacement. Electrodynamic linear motors on each end of the tester apply a sinusoidal action which forces fluid into and out of mock arteries causing them to expand and contract. A laser micrometer measures the radial strain by scanning the outside diameter of the arteries at 1200 scans per second.

Device OD Mock Artery # *Frequency
1.5mm- 7.0mm 12 50Hz - 60Hz
7.0mm - 10mm 8 - 12 40Hz - 60Hz
10mm - 20mm 4-8 35Hz - 55Hz
20mm - 40mm 4-6 15Hz - 35Hz

 * estimates based on 3% - 5% physiological compliance

Test Protocol & Set Up:

MDT tests are conducted in accordance with ANSI/ISO/IEC 17025-2005. Testing schedules and resource needs are determined during project kick off meetings with MDT engineers and the customer. The services are performed in accordance to standard operating procedures and test protocols specific to the service. For feasibility or non standard tests, MDT will develop a method and protocol with the customers input and will review the final process with the customer prior to initiation of the test. The customer will be notified of the final method prior to test start to align expectations before the test is initiated. 

Mock Artery Geometry:

Recently regulatory bodies, including the FDA, have begun requesting that pulsatile durability tests be performed in a physiologically relevant geometry. MDT is pleased to provide customized mock artery geometries and fixtures to accommodate the physiological application site of your device.

Straight Pulsatile Durability Test:
MDT provides custom mock arteries for intravascular devices in a range of sizes. Mock arteries are available in either latex or silicone. Please refer to the table above for device OD size ranges and mock artery quantity accommodations on the SGT testers.

Bifurcated Pulsatile Durability Test:
MDT provides custom mock arteries for intravasular devices with bifurcated applications (see picture above). Standard methods used a bifurcated latex tube, which can only accommodate a single device per tube/tester position and the maximum frequency was 30 - 40Hz. MDT's new approach models the physiological geometry in a custom dipped straight latex tube. For example, the aorta/renal artery intersection geometry (modeled in pink) can be maintained with addition of a straight coaxial aorta (modeled in clear). This geometry can be replicated twice along the length of a single test position, thus accommodating more samples. Additionally, this configuration is more stable and can run at higher frequencies. This test can accommodate a wide range of device sizes and test configurations.

Device Branch OD Bifurcation Angles Mock Artery # Frequency
3mm - 10mm 30° - 90° 6 - 8 40Hz - 60Hz

Curved Pulsatile Durability Test:
Please click here to visit our In Vitro Curved Pulsatile Durability test page for more information.

Inspections & Services Offered:

MDT offers several inspection methods including:

Test Monitoring & Weekly Updates:

The test equipment software monitors the cycle count, displacement, and pressure throughout the duration of the test. MDT engineers monitor the test daily and record the temperature and pressure for the system, as well as the outside radial strain at predetermined positions for each device being tested. MDT sends weekly updates to ensure customers are apprised of the status of their test. Updates include raw data collected throughout the week for the customer’s analysis.

Test Reports:

MDT tests are conducted in accordance with ANSI/ISO/IEC 17025-2005. In compliance with this standard, MDT test reports include comprehensive documentation and summary of the test protocol and results. All reports are GLP compliant and can be submitted directly to regulatory agencies. Any test method deviations, additions, or exclusions are documented and reviewed with the customer prior to beginning the test. Information within the report includes the specific test conditions, statements of compliance with test protocol and the estimated measurement uncertainty. The reported results only relate to the items tested. Any opinions and interpretations provided will be clearly marked as such in the test report. Additional information required by customer specific methods will also be noted. At the conclusion of the test, MDT provides the customer with a Microsoft Windows formatted CD containing copies of all raw data, inspection results, or other information collected during the test (contact an MDT representative to see an example test report).   

Please take a few moments to tell us more about your device and test requirements in our short questionnaire, and we will be happy to provide you with a quote.

 

In Vitro Pulsatile Durability Testing
In Vitro Pulsatile Durability Testing
In Vitro Pulsatile Durability Testing