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Coronary Stent Approved for Sale in Europe

Devax Inc., a medical device developer in Lake Forest, California says it received the Conformité Européenne (CE) mark for its AXXESS stent system designed for the treatment of coronary and vascular bifurcation lesions. The CE mark certifies that a product has met EU health, safety, and environmental requirements, allowing the company to market the stent in the European Union and other countries that recognize the CE mark.

The company says bifurcation lesions occur in approximately 20 percent of patients that are treated for ischemic heart disease — reduced heart pumping that can lead to congestive heart failure — with coronary angioplasty and stenting. Recent large scale clinical studies have shown that lesions located at vessel bifurcations increase the frequency of major adverse cardiac events by as much as 40 percent compared to lesions in straight vessel segments.

Devax says its AXXESS System is a self-expanding Nitinol (nickel titanium alloy) stent designed for the treatment of coronary and vascular bifurcation lesions. The conical shape of the stent is designed to conform to the bifurcation anatomy and provide full access to both branches for additional interventional procedures.

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