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Vivant Medical And Rhode Island Hospital Announce Beginning Of Clinical Study in Microwave Ablation For The Treatment Of Lung Cancer


10/19/2005 5:11:31 PM

MOUNTAIN VIEW, Calif. and PROVIDENCE, R.I., Sept. 20 /PRNewswire/ -- Vivant Medical and Rhode Island Hospital announced the beginning of a clinical study to determine the effectiveness of microwave ablation for treatment of lung cancer. In the study, Rhode Island Hospital will be using Vivant's VivaWave(TM) Ablation System, which has received FDA 510(k) clearance for coagulation of soft tissue. Damian Dupuy, MD, Director of Minimally Invasive Therapy and Ultrasound at Rhode Island Hospital, will be the principal investigator.

Microwave ablation is a new, heat-based treatment used to destroy tumors. Under the lead of Dr. Dupuy, Rhode Island Hospital's staff has already performed procedures in over 50 patients using VivaWave to ablate multiple masses in soft tissues including kidney, liver, bone, and adrenal glands. Due to its consistency, predictability, safety, reduced procedure times, and ability to treat large lesions, the VivaWave system is being developed as a promising and attractive option for patients with lung cancer who are typically not candidates for surgery and may not be able to be treated with current thermal therapy such as radio-frequency ablation. To date, Rhode Island Hospital is the largest user of microwave ablation.

Dr. Dupuy, said, "This development is in keeping with Rhode Island Hospital's commitment to providing our patients with the most recent advances in cancer treatment. Our research will result in a greater understanding of cancer and more effective, less traumatic treatment for our patients." Dupuy also noted, "As a large majority of lung cancer patients are not surgical candidates, VivaWave and microwave ablation offers doctors and their patients a much-needed option."

"We are pleased with the initiation of this study and look forward to broadening the use of the VivaWave system for the treatment of lung cancer," said Rod Young, Chief Executive Officer at Vivant Medical. "Approximately 174,000 new cases of lung cancer will be diagnosed in 2004, accounting for 13% of all new cancer cases. We believe that the VivaWave has the potential to aid doctors in effectively and safely treating patients with lung cancer who are left with precious few alternatives."

Dr. Dupuy was one of the pioneers in the development of radio-frequency ablation, the current industry standard in thermal ablation. Attracted by VivaWave's potential versus radio-frequency ablation, Dr. Dupuy is now a leading expert in microwave ablation.

About Vivant Medical, Inc.

Vivant Medical, Inc. develops novel and proprietary microwave ablation technology for the minimally invasive treatment of benign and cancerous soft tissue tumors. Vivant's next generation VivaWave(TM) 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 around the US. The VivaWave Microwave Ablation System is developed to overcome the limitations of current thermal ablation technologies and provides an attractive option for local control and/or pain palliation of unresectable tumors.

The Company's management team has extensive experience in the medical device marketplace. Vivant's founder, Dr. Thomas J. Fogarty, MD, first pioneered commercially successful products when he developed a line of balloon-based vascular catheters. Vivant Medical, Inc. is located in Mountain View, California, USA.

About The VivaWave(TM) Ablation System

The VivaWave Microwave Ablation System overcomes limitations of current thermal ablation technologies, the standard of treatment for oncology patients who are not candidates for surgery. Of patients with liver and lung tumors, 80% fall into this category. For these patients, microwave ablation would not preclude adjuvant treatment with chemotherapy and/or radiation. It can be an option for patients where other thermal modalities cannot be used due to tumor size or location. The system offers potential advantages to current thermal ablation methods in the following ways:

a. Minimally invasive procedure b. Consistency and predictability of ablations c. Fast procedure times d. Ability to treat large lesions (over 3 cm.) e. Increased safety due to the elimination of grounding pads f. Reduced pain possible because microwave does not send electrical current through the body g. Range of probe designs for maximum flexibility to match tumor geometries About Rhode Island Hospital

Rhode Island Hospital is an academic medical center affiliated with Brown Medical School. Among the medical staff are national leaders in oncology, cardiology and orthopedics. It is also the home of the New England Gamma Knife Center and the only site in Rhode Island to offer kidney and pancreas transplants. It serves as the Level 1 trauma center for Rhode Island and southeastern Massachusetts, with a new $40 million emergency department scheduled for opening in early 2005. Founded in 1863, it is a private, not-for-profit hospital and is the largest of the state's general acute care hospitals.

CONTACT: Vivant Medical Alice Jack Vice President, Marketing and Sales 650-694-2900 ajack@vivantmedical.com Rhode Island Hospital The Ruth Group Nancy Cawley Janine McCargo Senior Media Relations Officer Account Executive 401-444-4039 646-536-7033 ncawley@lifespan.orgjmccargo@theruthgroup.com

Vivant Medical; Rhode Island Hospital

CONTACT: Alice Jack, Vice President, Marketing and Sales of VivantMedical, +1-650-694-2900, ajack@vivantmedical.com; Nancy Cawley, Senior MediaRelations Officer of Rhode Island Hospital, +1-401-444-4039,ncawley@lifespan.org; Janine McCargo, Account Executive of The Ruth Group,+1-646-536-7033, jmccargo@theruthgroup.com


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