Absorbable Vascular Stents Are Subject of New Surgical Devices Standard
Patients with blockages in their coronary vasculature have historically been treated with permanent metallic stents, metal mesh tubes that open clogged blood vessels, restore blood flow and keep the vessel open over time. Certain patients can now be treated with an absorbable stent, otherwise known as a vascular scaffold, available in international markets.
Absorbable stents are designed to open clogged blood vessels and restore blood flow, similar to a permanent metallic stent, but are temporary and completely absorbed in time. A new ASTM standard will be used to drive consistency in the way vascular scaffolds are evaluated, from initial manufacture to absorption within the patient’s body.
ASTM F3036, Guide for Testing Absorbable Stents, was developed by a task group of Subcommittee F04.30 on Cardiovascular Standards, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.
“The physical and mechanical properties of a vascular scaffold change as the device is absorbed in the body, resulting in unique considerations for testing absorbable scaffolds compared with permanent metallic stents,” says Julia Fox, Ph.D., program manager, Abbott Vascular, and chair of F04.30.
ASTM F3036 provides specific criteria for evaluating physical and mechanical characteristics to guide industry, academia, government agencies and any other additional parties evaluating vascular scaffolds.
According to Fox, while metallic stents and absorbable stents have similar clinical objectives, there are fundamentally different characterizations between the two types. ASTM F3036 provides specific considerations for evaluating physical and mechanical characteristics of absorbable vascular stents.