MOUNTAIN VIEW, Calif., April 18 /PRNewswire/ -- Vivant Medical, Inc. announced that data from a clinical study using its VivaWave(TM) Microwave Ablation system was presented in a poster session at the American Hepato-Pancreato-Biliary Association's 2005 Meeting, taking place April 14-17, 2005 at the Westin Diplomat Resort in Ft. Lauderdale, FL. Robert Martin, MD, FACS, Assistant Professor of Surgery at the Division of Surgical Oncology of the University of Louisville presented a poster titled "Microwave Hepatic Ablation Leads to a More Efficient and Effective Hepatic Ablation."
The study, a prospective, multi-institutional trial and retrospective study of procedures taking place from January through October 2004, represents the first report of a clinical study of microwave ablation as the primary therapy in patients with hepatic malignancies. In it, microwave ablation was utilized to treat 67 hepatic tumors in 20 subjects; a median of two tumors (range 1-13 tumors) with a median size of 3 cm (range 1.5 to 4.5 cm) were treated in the study. Multiple types of microwave probes (surgical straight VivaTip(R), VivaRing(R) Atom, and laparoscopic VivaTip(TM)) were utilized depending on location and size. Total median ablation time for each patient was 10 minutes (range 5 to 40 minutes). In all cases, multiple ablations of hepatic lesions were performed simultaneously.
In the abstract, Dr Martin concludes, "Microwave ablation represents a faster and safer way to perform hepatic ablations in patients. The ability to perform bracketed ablations in tumors that are not perfectly spherical may result in more complete initial ablations and fewer ablation recurrences. The ability to perform multiple ablations simultaneously allows for a more efficient surgical procedure, especially in patients with multiple lesions."
Rod Young, Chief Executive Officer of Vivant Medical, said, "We are extremely pleased to see data that validates our work to offer doctors a highly attractive option in the treatment of hepatic tumors. For the first time, follow-up data provides evidence to support the safety and efficacy of Vivant's VivaWave microwave ablation system for treating hepatic tumors."
About Vivant Medical, Inc.
The VivaWave Microwave Ablation System is a novel and proprietary technology developed by Vivant Medical, Inc., Mountain View, California, USA. The VivaWave System has received FDA 510(k) clearance for the coagulation of soft tissue, and the system is in clinical usage at medical centers and university hospitals worldwide. The VivaWave System has not been granted the CE Mark and is not available for sale or supply in Europe.
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