We are a world leader in medical device testing, equipment, services and consulting. Core products & services centered around stent testing, heart valve testing, acute particulate stent testing, particulates shed from catheters guide wires, implantable device delivery systems, fatigue to fracture stent testing, and coated durability device testing. Over 30 years of experience.
Dynatek’s products are designed to fulfill current and anticipated international regulations. Learn more about how our machines satisfy the following standards:
Acute medical particulate testing device patent awarded to Dynatek Labs
An acute medical particulate testing device for determining particle shed from a medical device during implantation. The device includes a closed loop system through which a solution is forcibly passed. An inlet port allows a catheter-mounted medical device to be incorporated into the flow loop. At least one tortuous passage is provided to replicate the vascular pathway and tortuosity which simulates the turns and bends and rubbing that affect particulate release from an implantable medical device as it is passed through the vasculature. Read more
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
The Acute Particulate Tester (pat. pend.) moves to an 8 foot platform.
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.
Acute Particulate Testing in our lab is growing fast
Acute Particulate Testing demand is growing and Dynatek is scaling up to meet the demand.
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
- 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.
Dynatek Labs, Inc.
105 East 4th Street
Galena, MO 65656