New Test Method Proposed for Vascular Stents

A proposed new standard test method for radial stiffness and strength of balloon expandable stents will help the medical device industry with the measurement and design of vascular stents.

The future standard--WK15227--was proposed by the American Society of Testing and Materials (ASTM; West Conshohocken, PA, USA) International committee F04 on medical and surgical materials and devices. The proposed standard will be used to support submissions to regulatory agencies and to assist in the comparison of new products to existing ones. A standardized method for radial stiffness and strength assessment may also indirectly help to improve understanding of the causes of late stent thrombosis, as there is some evidence that this often-fatal coronary event is associated with stent malapposition, which is often the result of insufficient radial stiffness or strength.

"Vascular stents are commonly used as a minimally invasive way to treat stenosis in arteries and improve blood flow to the heart, kidneys, brain, and legs,” said Kenneth J. Cavanaugh, Ph.D., co-chair of the F04 task group on endovascular device test methods. "Due to the challenging service environment that stents face in vivo, the radial stiffness of a stent is critical to its function of keeping the arteries open and eliminating abrupt closure.”

Dr. Cavanaugh noted that while the task group has traditionally focused on the development of standards for vascular stents, it is also interested in developing test methods for other endovascular devices, such as aortic aneurysm endovascular grafts, embolic protection devices, and inferior vena cava filters. Established in 1898, ASTM International is one of the largest international standards development and delivery systems in the world.


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American Society of Testing and Materials