ChromoFlex Heart Stent Receives European Medical Device Approval

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DISA Vascular announces the latest in medical technology for heart health with the ChromoFlex coronary stent.

We are very excited about this device which uses the ChromoFlex as the delivery platform. The drug-eluting stents currently on the market are bulky and difficult to deliver. With the low-profile, highly flexible ChromoFlex as the platform for our drug coating, clinicians will enjoy a profound improvement in deliverability.

Medical device company DISA Vascular (Pty) Ltd today announced European CE Mark approval of its ChromoFlex coronary stent system. The latest in technology for heart disease, the ChromoFlex is DISA Vascular's latest generation stent platform made from a special cobalt chromium alloy. The stent, which incorporates ultra-thin struts, a very low delivery profile, increased vessel wall support and improved flexibility, provides a competitive treatment alternative to drug-eluting stents.

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 against the vessel wall. Despite the huge success of stenting as a medical treatment of coronary artery disease, a certain percentage of patients who are treated with stents return with a condition called “restenosis”. This re-narrowing of the artery after stenting is due to a build up of scar tissue within the stent.

Discussing the design features of the ChromoFlex, Damian Conway, R&D Director of DISA Vascular said, "A number of clinical studies have shown that judicious stent design can reduce restenosis considerably. By exploiting the high strength and angiographic visibility of our particular cobalt chromium, we have been able to produce an incredibly refined structure while still providing excellent vessel wall support and good visibility. It is our belief that this ultra-thin-strut ChromoFlex will out-perform the other thicker-strut stents on the market, and produce clinical results that begin to compete quite convincingly against the drug-eluting stents currently in use."

Dr. Gregory Starke, CEO of DISA Vascular, said that the launch of the ChromoFlex is the precursor to DISA Vascular's drug-eluting stent, the Taxochrome. "We are very excited about this device which uses the ChromoFlex as the delivery platform. The drug-eluting stents currently on the market are bulky and difficult to deliver. With the low-profile, highly flexible ChromoFlex as the platform for our drug coating, clinicians will enjoy a profound improvement in deliverability." DISA Vascular's Taxochrome stent is currently undergoing pre-clinical trials, and is scheduled for a human clinical study in 2005.

The ChromoFlex stent is based on DISA Vascular’s flagship stent the S-Flex, which was the first Class III device to obtain CE approval in South Africa in 2000. The S-Flex has been sold internationally for the past five years and has enjoyed very favourable independent reviews and shown excellent long-term clinical performance.

DISA Vascular (Pty) Ltd is a medical device company, focused on innovative vascular devices for the treatment of heart and peripheral vascular disease. DISA Vascular is a privately owned company in which Bioventures (http://www.bioventures.co.za) holds a substantial equity position.

Contact: Dr. Gregory Starke, Tel: +27 21 4480923, or visit http://www.disavascular.com

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