Pluromed, Inc. has completed enrollment in its LeGoo™ off-pump coronary artery bypass clinical study, based on a protocol reviewed by the U.S. Food and Drug Administration (FDA). When completed, the report of the study will be filed with the FDA as part of the company's submission for U.S. regulatory approval of LeGoo™.
(PRWEB) -- Pluromed, Inc. today announced that it has completed enrollment in its LeGoo™ off-pump coronary artery bypass clinical study, which is evaluating the clinical efficacy of LeGoo™ as compared to a traditional vessel loop. This prospective, randomized trial commenced enrollment in 2008 and has reached its goal of 110 patients, enrolled at 9 hospitals in 4 countries. Principal investigators for the trial were Gerhard Wimmer-Greinecker, M.D., Ph.D., Ardawan Rastan, M.D., Ph.D., Volkmar Falk, M.D., PhD, Olivier Bouchot, M.D., Jan Gummert, M.D., Ph.D., Jean-Philippe Verhoye, M.D., Ph.D., Louis Perrault, M.D., Ph.D., Anno Diegeler, M.D., Ph.D. and Jos G. Maessen, M.D., Ph.D.; Dr. Valavanur A. Subramanian, Chairman of the Department of Cardiothoracic Surgery at The Lenox Hill Heart and Vascular Institute of New-York, served as Chairman of the study’s Data Safety Monitoring Board.
Pluromed’s LeGoo™ is a polymer-based device which is comprised of a non-toxic and biocompatible gel that exists as a liquid at low temperatures and rapidly transitions to a solid at body temperature, forming a plug that can occlude blood vessels. LeGoo™ is injected into a blood vessel that is intended to be occluded, where it stays in a “plug” form for several minutes allowing the surgeon to work in a bloodless field. The gel dissolves with time (spontaneously) or can be reversed back to liquid instantly by cooling the site with ice or irrigating with cold saline. Once dissolved below a minimum concentration, the polymer cannot never re-so
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