The primary purpose of the study is to demonstrate the clinical safety and efficacy of LeGoo™ in comparison to a standard vessel occlusion method (i.e. vessel loops). Although LeGoo™ is also designed for use in other vascular surgeries where temporary vessel occlusion is desired, this study specifically focuses on the use of LeGoo™ in off-pump coronary bypass (OPCAB, as a most sensitive model of adverse changes that may occur at any vascular site outside of the neurovascular system. The primary endpoint is the proportion of anastomoses (process of suturing the bypass graft to the coronary artery) in which satisfactory hemostasis is achieved.
Dr. William J Cohn, Director of Minimally Invasive Technology at Texas Heart Institute, is the medical director of the study. "With enrollment completed, our focus now turns to data monitoring, completion of follow up and preparation for filing with the U.S. Food and Drug Administration and for primary endpoint publication” said Dr. Cohn. "We are grateful to all the trial investigators who have worked so diligently to reach this milestone."
“This important trial is the latest example of the commitment of leading vascular and cardiovascular surgeons, who seek less traumatic methods to improve patient outcome”, said Jean-Marie Vogel, President and CEO of Pluromed. “We appreciate the participation of the 22 leading physicians and 13 research coordinators, whose efforts led to the successful completion of enrollment."
About Pluromed, Inc.
Pluromed, Inc., Woburn, Massachusetts, founded in 2003, is pioneering the use of atraumatic gel plugs to improve the safety, efficacy and economics of medical interventions. These products potentially address a broad surgery market that includes cardiac and vascular surgery, prostate, kidney and liver surgery, plastic/reconstructive surgery, trauma/battlefield applications and the treat
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