DISA Vascular’s Small-Vessel Heart Stent Receives European Approval

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Medical device company receives CE Mark approval for the cobalt chromium ChromoFlex Micro.

Medical device company DISA Vascular (Pty) Ltd today announced European CE Mark approval and market launch of its ChromoFlex Micro stent system for small coronary vessels. This follows CE approval of the large-vessel version, the ChromoFlex, in September 2004.

Coronary stents are tiny metallic tubular mesh-like structures which are used to re-open coronary arteries after they have become obstructed by the build-up of plaque. A certain percentage of patients who are treated with stents return with a condition called “restenosis,” a build-up of scar tissue within the stent.

The ChromoFlex range is marketed as a competitive treatment alternative to drug-eluting stents to reduce restenosis.

Similar to the large-vessel ChromoFlex, the new Micro version has ultra thin struts. This feature has been shown to reduce restenosis dramatically in various independent clinical studies. This is made possible by the use of a special cobalt chromium alloy offering numerous advantages over the more conventional stainless steel because of its increased strength and radiographic visibility.

“Since the launch of the ChromoFlex stent in Europe and elsewhere, this product has performed extremely well,” said Dr. Starke, CEO of DISA Vascular. Starke noted that there are currently no cobalt chromium drug eluting stents on the market. DISA Vascular’s own program uses the ChromoFlex as the platform stent. Starke said he felt confident that properly designed cobalt chromium stents used for local drug delivery, such as the ChromoFlex & ChromoFlex Micro, will be markedly easier to deliver and have better clinical outcomes than the stainless steel drug eluting versions currently available.

According to Starke, the new Micro stent, for vessels 2.5 - 3.0mm in diameter, will have even better deliverability features than the large vessel version because of its extremely low profile and high flexibility. Smaller vessel stents are in high demand in Asian and Middle Eastern markets where DISA Vascular has strong market interests.

DISA Vascular (Pty) Ltd is a medical device company, focused on innovative vascular devices for the treatment of heart and peripheral vascular disease.

Contact:

Dr. Gregory Starke

+27 21 4480923

http://www.disavascular.com

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