Rafael Medical Technologies Ltd. has obtained US Food and Drug Administration (FDA) marketing approval for its SafeFlo Vena Cava Filter. The approval is for the permanent implantation of the filter in patients at risk of pulmonary embolism; safety and effectiveness as a retrievable or temporary filter have not been established.
Rafael Medical obtained EU CE Mark certification for the filter for both permanent and removal options in 2004.
The SafeFlo filter is an implanted expandable metal device used to capture hazardous blood clots caused by trauma, surgery or other medical conditions before they can reach the lungs, causing a pulmonary embolism. SafeFlo's design provides a double ring anchoring mechanism as an alternative to the standard strut-based designs of filters available on the market since the 1970s.
In late 2006, Rafael Medical raised $2.5 million at a company value of $16 million from Possis Medical Inc. (Nasdaq: POSS), which develops and makes cardiovascular and vascular treatment devices.
Published by Globes [online], Israel business news - www.globes-online.com - on May 21, 2009
© Copyright of Globes Publisher Itonut (1983) Ltd. 2009
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