February 5, 2010 – Enrollment is complete for the trial of a polymer-based gel that rapidly transitions to a solid at body temperature, forming a plug that can temporarily occlude blood vessels for heart surgery.
The LeGoo off-pump coronary artery bypass clinical study 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 nine hospitals in four countries.
Pluromed’s LeGoo is a polymer-based device which is comprised of a nontoxic 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 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 resolidify.
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 focused on the use of the device 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.
William E. Cohn, M.D., director of minimally invasive surgery 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.”
The polymer technology is used in Pluromed’s BackStop, a product used in the treatment of ureteral stones, is cleared for human use in Europe, Canada and the United States. LeGoo is approved for human use in Europe, but is not currently cleared for human use in the United States.
For more information: www.pluromed.com