ITGI Medical Ltd. (TASE:ITGI) has obtained US Food and Drug Administration (FDA) desigantion of two cardiovascular stents as humanitarian use devices (HUD). The Or Akiva-based company's share jumped 320% to NIS 0.21 on the news.
The compnay said the designation is a first step toward marketing approval.
ITGI obtained the HUD designation for its pericardium covered Over and Under Stent and its Aneugraft Stent. Both stents are already commercially available in Israel, Europe, and Latin America.
The pericardium covered stents are geared for treatment of bypass stenosis, aneurysms, and for emergency situations such as perforations.
In 2008, the company won a Frost and Sullivan award as a "revolutionary stent company".
Published by Globes [online], Israel business news - www.globes-online.com - on April 26, 2009
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