Dynatek’s new Fatigue-to-Fracture Tester highlighted in a paper presented at a recent ASTM International Symposium.
The American Society for Testing and Materials (ASTM) International subcommittee on Endovascular Test Methods developed the new standard ASTM F3211 Standard Guide for Fatigue-to-Fracture (FTF) Methodology for Cardiovascular Medical Devices.
Dr. Matthias Froscher of Cortronik presented a paper at ASTM’s Fourth Symposium on Fatigue and Fracture of Metallic Medical Materials and Devices in May 2018. This was the culmination of three years of research and instrument development by Dynatek and Cortronik. The paper “A New Approach for Fatigue-to-Fracture Testing of Coronary Stents” presented a test methodology taking the new ASTM standard into account, which can subject cardiovascular stents to hyperphysiological loading. In combination with FEA analysis, it can help to understand how stents fracture, e.g., to optimize device designs or evaluate the criticality of manufacturing process changes with regard to fatigue without the need to test to high numbers of cycles.
This testing was run on Dynatek’s patented FTF extreme conditions radial fatigue tester. The instrument utilizes Dynatek’s more than 30 years of experience designing and manufacturing medical device testing instruments. It provides extreme loading conditions to stents, so that they can be radially stressed to a much greater degree than previously possible.
This paper has been chosen for publication in STP 1616 on Fourth Symposium and Fatigue of Metallic Medical Materials and Devices to be available at the ASTM STP in the near future.
Acute medical particulate testing
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Dynatek’s products are designed to fulfill current and anticipated international regulations. Learn more about how our machines satisfy the following standards:
ASTM F2394 – 07(2017)
- ASTM WK60510
- ASTM WK60511
Dynatek’s innovations list continues to grow
- First to develop fatigue to fracture testing of stents.
- First to develop technology for integrated, real-time acute particulate testing.
- First commercially available coating durability tester with in-line particulate analysis.
- First to develop precise high-speed photographic verification protocols and procedures.
- First to offer a commercially available pulsatile artificial heart tester.
- First to use 5% to 7% compliance for mock vessels.
- First in the use of precise, optically clear mock vessels.
- First to use tuned fluid oscillation in heart valve testing.
- First to create velocity flow standard.
- First to introduce Dynamic Internal Compliance of mock vessels.
- First commercially available stent/graft durability tester with single ended pressurization. Read more
Dynatek rolls out a real Fatigue to Fracture solution
Acute Particulate Tester gets an upgrade
Representative in China
Room 1302, Aetna Tower, No.107 Zunyi Road
Shanghai 200051, China
Contact: Harry Zhong /Sales Manager
Dynatek is pleased to announce an exclusive distributorship and service agreement with DJK- Shanghai Yishi Trading Co, Ltd. for the Chinese market. Harry Zhong, sales manager, will serve as primary contact for new and existing customers.
DJK was established in 1948, and has grown into a comprehensive trading company with 32 overseas branches and offices. DJK has built a strong market presence in the medical device industry, as well as a variety of other sectors including aeronautics, petroleum products, pharmaceuticals, and electronics.
Moving forward, DJK will provide new and existing Chinese customers with prompt product support, as well as the opportunity for on-site demonstrations of new Dynatek equipment.
Dynatek is confident that this partnership will expand our market presence in China, and provide excellent customer service for years to come.
MD&M 2018 Anaheim, CA
Dynatek Labs attended the 2017 TCT (Transcatheter Cardiovascular Therapeutics) show in Denver, held Oct 30 through Nov 2 this year.
Drs. James Conti and Elaine Strope, owners of Dynatek; Kendra Conti, Global Sales Manager; and Chris Conti, Sr. Engineer, attended for Dynatek. The Acute Particulate Tester (APT), and the M6 Heart Valve Durability Tester, were showcased at this year’s exhibit.
Still haven’t seen Dynatek’s Acute Particulate Tester?
Make plans now to attend TCT 2017 and stop by our booth 4002, Oct. 30- Nov. 1, 2017.
Also featured will be our M6 accelerated durability tester for surgical and catheter-delivered heart valves as well as vascular occluders.
We look forward to seeing you there to discuss how Dynatek Labs can help with your vascular device durability and particulate testing needs!
Acute medical particulate testing device patent awarded to Dynatek Labs
Acute Particulate Testing in our lab is growing fast
No one tests faster than we do!
Test at accelerated speeds? Yes!
Test at physiological speeds? Yes!
Test at high temperatures and expanded pH levels? Yes!
Verify stent deflection using high speed photography? Yes!
ISO, ASTM and FDA regulations require the testing of stents and stent grafts for at least 380 million cycles. At physiological speeds of 72 beats per minute (1.2 Hz), it would take one month for 3.1 million cycles of testing, or literally 10 years to meet the regulatory requirements. To meet the regulatory requirements of 380 million cycles, regulatory agencies allow testing at accelerated speeds, leading to shorter test periods, and significantly lower testing costs.
Dynatek’s testers feature proprietary Hyper Drive motors that are capable of over 60 Hz or 3,600 rpm, far in excess of physiological conditions. Assuming the intravascular device can tolerate such speeds, 380 million cycles can be completed in 10 weeks!
Dynatek can assist you in developing a test protocol that will offer you the fastest possible speed for accelerated durability testing of stents, stent grafts and intravascular devices.
In addition to accelerated speeds, some customers have chosen to test at higher temperatures and expanded pH levels, as part of their test-to-failure protocols. Contact us to find out more about such testing protocols.
Verification of stent deflection using high speed photography is the most accurate way to measure deflection. Dynatek routinely performs accelerated durability testing of intravascular devices using high speed photography.
No one tests faster than we do!
Acute Phase Particulate Testing of Stents, Stent-grafts and Stent Delivery Systems
Dynatek Labs performs Acute Phase Particulate Testing of a variety of vascular devices. Acute Phase Particulate Testing of vascular devices such as stents, stent-grafts, and stent delivery systems includes:
- Real-time Particulate Matter Evaluation during Deployment and Withdrawal
- Coating Integrity Inspection
Dynatek Labs provides a ‘one stop’ facility for your Acute Phase Particulate Testing requirements.