Edwards Enters Embolic Filtration Market With Embol-X Technology
This article was originally published in The Gray Sheet
Executive Summary
Edwards Lifesciences will offer embolic filtration technology developed by Embol-X, Inc. for use during open-heart procedures such as valve replacement under an asset purchase valued at about $10 mil
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Embol-X U.S. launch
185-patient study at Goethe Universitat in Frankfurt shows that Embol-X reduces cerebral injury 74% in high-risk patients compared to procedures without the filter, Edwards notes in materials for U.S. launch of aortic embolic protection device, announced Aug. 20. Edwards acquired the device through its $10 mil. purchase of Embol-X, Inc. in May (1"The Gray Sheet" May 5, 2003, p. 24). Embol-X is the only aortic embolic protection device approved in the U.S. for use during cardiac surgery, the company claims...
Embol-X U.S. launch
185-patient study at Goethe Universitat in Frankfurt shows that Embol-X reduces cerebral injury 74% in high-risk patients compared to procedures without the filter, Edwards notes in materials for U.S. launch of aortic embolic protection device, announced Aug. 20. Edwards acquired the device through its $10 mil. purchase of Embol-X, Inc. in May (1"The Gray Sheet" May 5, 2003, p. 24). Embol-X is the only aortic embolic protection device approved in the U.S. for use during cardiac surgery, the company claims...
Clinical Efficacy, Equivalence Concerns Hinder Embol-X Aortic Filter Review
The difficulty of reconciling PMA clinical trial results with a 510(k) submission may hamper Embol-X, Inc.'s chances of achieving FDA clearance for its Embol-X aortic filter