EndoSonics Receives FDA Clearance for the ChromaFlo Option for the Oracle InVision Ultrasound Imaging System; Adds Colored Blood Flow to Intravascular Ultrasound Images.RANCHO CORDOVA, Calif.--(BW HeatlhWire)--Aug. 19, 1997-- EndoSonics Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ESON ESON Ethernet Switched Optical Network (Alamedia Networks) ESON Ethnobotanical Society of Nepal ) announced today that it has received clearance from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to begin U.S. marketing of its ChromaFlo option for the Oracle InVision(TM) ultrasound imaging system. EndoSonics currently markets the Oracle InVision system which provides black and white cross sectional images of the artery. The ChromaFlo option, when added to the Oracle InVision ultrasound imaging system, utilizes patented, proprietary technology to detect blood flow and represent it as a color (red). The company believes this blood flow information, coupled with state of the art image quality available from EndoSonics' Visions(R) Five-64(TM) catheter, should enhance image interpretation. ChromaFlo is designed to improve the diagnosis of certain anatomical features which may be more apparent when blood flow is differentiated from tissue. Identification of these features may be important in the successful treatment of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. . The ChromaFlo option, an intravascular ultrasound (IVUS IVUS Intravascular ultrasound, see there ) industry first, is possible because the InVision system uses an all-digital, all-electronic design, as opposed to a mechanical platform used by competitive products. The ChromaFlo option can be accessed through "one button activation" and requires no additional catheter. This feature can be ordered on new systems, or installed on existing Oracle InVision imaging systems. Dr. Greg Braden of The Bowman Gray School of Medicine at Wake Forest University, commented, "Color imaging of the blood adds a new dimension to image interpretation. I believe this may simplify image interpretation and provide a significant benefit to both new and experienced users." Reinhard Warnking, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of EndoSonics commented, "I am very excited about the ability to market this breakthrough technology. Historically, the introduction of color flow imaging to other external ultrasound applications has had a very significant impact on clinical acceptance. We anticipate that ChromaFlo has the potential to impact the IVUS marketplace in a similar way. It is useful in both simple and more complicated cases, adds nothing to the catheter cost, and should make images easier to interpret." EndoSonics develops, manufactures and markets intravascular ultrasound (IVUS) imaging systems and catheters to assist in the diagnosis and treatment of cardiovascular and peripheral vascular disease Peripheral Vascular Disease Definition Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms. . EndoSonics' IVUS imaging products enhance the effectiveness of the diagnosis and treatment of the coronary artery coronary artery n. 1. An artery with origin in the right aortic sinus; with distribution to the right side of the heart in the coronary sulcus, and with branches to the right atrium and ventricle, including the atrioventricular branches and by providing important diagnostic information not available from conventional x-ray angiography angiography or arteriography X-ray examination of arteries and veins with a contrast medium to differentiate them from surrounding organs. The contrast medium is introduced through a catheter to show the blood vessels and the structures they supply, including . The information includes the location, amount and composition of atherosclerotic plaque and enables physicians to identify lesion characteristics, select an optimum form of treatment, position therapeutic devices and promptly assess the results of treatment. The recently completed merger of Cardiometrics Inc. adds products which measure blood flow impairment caused by coronary artery disease. Cardiometrics' principle products, the FloWire(R) Doppler guide wire and FloMap(R) ultrasound instrument, represent a significant clinical advance -- on-line functional testing of blood flow impairment in the cath lab -- enabling cardiologists to evaluate the appropriateness of angioplasty interventions and assess post-procedural results. For additional information on EndoSonics, please visit Web site http://www.endosonics.com . This press release contains forward-looking statements that involve risks and uncertainties. The company's actual results may differ significantly from the results discussed in the forward- looking statements. For a discussion of factors that might result in different outcomes, see the company's Form 10K/A K/A Knowledge and Abilities and the Registration Statement on Form S-4 filed with the Securities and Exchange Commission on June 13, 1997. CONTACT: EndoSonics Corp. Donald Huffman, 916/638-8008 or Morgen-Walke Associates Inc. Doug Sherk, John Swenson, 415/296-7383 or Sandy Badurina, Joshua Passman, 212/850-5600 |
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