How Material Testing can Assure Quality in Stent Manufacturing

QMED article from Sep.30, 2013 at:

http://www.qmed.com/mpmn/medtechpulse/how-materials-testing-can-assure-quality-stent-manufacturing

From the article:

Comprised of biocompatible metal or biodegradable polymers, stents bear a complex geometry, enabling them to act as effective scaffolds. As they must be able to push against the internal walls of the blood vessel or other conduit into which they are placed, their mechanical integrity is of the utmost importance. An insufficient level of flexibility can result in tissue damage while insufficient rigidity inhibits the device’s capacity to support natural flow.

Designed to address specific applications, stents are available in a wide range of sizes, diameters, mesh patterns, and strengths.An intraluminal coronary artery stent is a small, self-expanding, metal mesh tube placed inside a coronary artery following a balloon angioplasty procedure. This particular type of stent is designed to prevent the artery from re-closing. As it is placed within an artery, it is subjected to rather large forces that must be thoroughly characterized during the product development cycle and as part of quality management initiatives.

Zwick PrecisionLine Vario system
The Zwick PrecisionLine Vario system

Drug-eluting stents are among the most recent types of stents approved for use. Coated with time release pharmaceutical compounds, drug-eluting stents are also utilized in cardiovascular procedures to maintain blood flow. According to the New England Journal of Medicine, more than 500,000 patients in the United States are implanted with drug-eluting stents annually. A chief benefit is the reduced risk of repeat revascularization, a condition in which the patient requires additional cardiovascular procedures.

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