Vivant Medical and Wake Forest University Complete Ablate and Resect Study
Patients in Study were treated Using the VivaWave(TM) Microwave Ablation System in Renal Tumors
MOUNTAIN VIEW, Calif., and LOUISVILLE, Ky., Nov. 9, 2004 /PRNewswire/ -- Vivant Medical, Inc. and Wake Forest University Baptist Medical Center today announced completion of an "ablate and resect" study to determine the effectiveness of microwave ablation for treatment of renal tumors. In the study, Wake Forest used Vivant's VivaWave(TM) Ablation System, which has received FDA 510(k) clearance for coagulation of soft tissue. Peter E. Clark, M.D., Assistant Professor, Department of Urology, is the principal investigator.
Surgery is still the treatment of choice for most kidney tumor patients. In many cases, this means the removal of at least one kidney. However, surgery is not an option for some patients, including select patients with only one kidney; those who have other medical conditions that might prevent surgery; or those for whom surgery or post-surgical recovery would be difficult.
Vivant's VivaWave microwave ablation system presents a fast, minimally invasive alternative to such patients, using heat to destroy tumors. The VivaWave(TM) energy applicator allows doctors to ablate with more than one applicator concurrently which can shorten procedure times, either surgically or percutaneously, with added safety for the patient since ablation grounding pads are not required. Further, in cases where the tumors are large or close to a vital structure or organ, microwave ablation may be less problematic than other thermal ablation technologies, such as radio frequency ablation or cryoablation.
Dr. Clark commented, "So far, we've been able to perform ablations on 10 patients with the VivaWave(TM) system. The system works efficiently and safely in our hands. We feel this is an exciting new technology that may soon offer our patients another option for the management of solid kidney tumors."
"An estimated 35,000 Americans are diagnosed annually with kidney cancer and more than 12,000 die of the disease," said Rod Young, Chief Executive Officer at Vivant Medical. "Vivant is happy that it can offer patients added safety, simplicity, and flexibility benefits through our VivaWave system. Our VivaTip(TM) energy applicator offers doctors a level of flexibility unrivaled among thermal ablation technologies."
About Wake Forest University Baptist Medical Center
Wake Forest University Baptist Medical Center is a health system comprised of North Carolina Baptist Hospital and Wake Forest University School of Medicine. Serving North Carolina and surrounding states, it operates 1,291 acute care, rehabilitation and long-term care beds. The Medical Center is involved in the training of more than 30,000 health care professionals and scientists each year, and receives more than $140 million annually in outside grants in support of its research mission. For more information, visit the Wake Forest University website.
About Vivant Medical's VivaWave(TM) Microwave Ablation System
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 throughout the United States. For more information, visit the Vivant Medical website.
11/12/2004
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