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Laguna Niguel, CA - September 18, 2002 - Volcano Therapeutics, Inc. has enrolled the first 20 patients in its international intracoronary thermography safety trial. Earlier this year, clinical sites in Auckland, New Zealand, Essen, Germany and Milan, Italy began enrolling patients in a trial designed to test the safety of Volcano Therapeutics' thermography system and to support regulatory filings for product commercialization in several markets around the world. Investigators report that all devices have performed as expected and met all safety endpoints.
Volcano Therapeutics' intracoronary thermography system includes a single-use, basket-tipped catheter with six discrete temperature sensing thermocouples, positioned to measure blood and circumferential vessel wall temperatures in the major coronary arteries. A free-standing processing unit displays temperature readings in graphic format. When used with an automatic catheter withdrawal device, the system allows thermal mapping of an entire coronary artery in seconds.
Mark Webster MD, Director, Cardiac Catheterization Laboratories, Green Lane Hospital, Auckland, New Zealand was among the first to test the system. "We were pleased to participate in the initial trials of this promising new technology. We have used the Volcano thermography system in nine patients with coronary disease. In each case the device performed as expected." Dr. Webster will present his initial results during the scientific sessions at the 2002 Transcatheter Cardiovascular Therapeutic ("TCT") international symposium on Wednesday, September 25, 2002 at the Washington Convention Center, Washington DC.
"The Volcano Therapeutics catheter has a simple, but elegant design and was easily and safely deployed during several cardiac interventions. I see a great future for this technique," said Professor Raimund Erbel, University Clinic of Essen, Germany. Dr. Erbel will discuss his findings at the Vulnerable Plaque workshop to be held on Friday, September 27, 2002 at the TCT meeting.
Scott Huennekens, CEO, Volcano Therapeutics, Inc. added, "The interest in intracoronary thermography is significant, as evidenced by the participation in this early trial by several leading international centers. We are certainly encouraged by the positive initial findings of the trial."
About Cardiovascular Disease
Cardiovascular disease is America's number one killer. Over one million people die from cardiovascular disease each year. There are currently over 1 million people in the United States each year that suffer from heart attacks and over half of these people die, that's about 10,000 people each week or one person every minute. Prior medical understanding was that fat laden material slowly built up on the surface of passive artery walls. Eventually the artery was clogged resulting in a heart attack. Scientists now understand that most heart attacks do not happen in this manner. Instead, new medical discoveries now show that heart attacks are caused by undetected vulnerable plaques that are embedded in the artery, become inflamed, and then rupture causing deadly heart attacks. Fortune magazine recently estimated the market potential for the detection and treatment of vulnerable plaques at over $10 billion.
About Volcano Therapeutics, Inc.
Volcano Therapeutics, Inc. was founded in 2001. Volcano is focused on the discovery, development and commercialization of products for the detection and treatment of vulnerable plaque in the coronary arteries and peripheral vascular system. Currently under development are technologies that could be potentially useful in detecting and treating patients who are at risk for developing plaque rupture and subsequent adverse cardiac events. For more information, please visit us at www.volcanotherapeutics.com
Company Contacts:
United States:
Scott Huennekens, President & CEO
Volcano Corporation
2870 Kilgore Road
Rancho Cordova, CA 95670 USA
(916) 638-8008
(916) 638-8112 (fax)
Japan:
Junichi Osawa, President & Managing Director
Koji Osaka, General Manager
Ebisu Shimizu Building 4F
1-25-7 Ebisu
Shibuya-Ku Tokyo
150-0013 JAPAN
+81-3-5791-2616
Europe & Middle East:
Michel Lussier, Vice President, Europe, Africa, Middle-East
Volcano Europe SA/NV
Excelsiorlaan 41
B-1930 Zaventem, Belgium
+ 32 475 80 00 97
+ 32 2 679 10 72 (fax)