EndoSonics Receives 510-K Clearance for the Cardiometrics FloWire 300 and FloWire 300XT Doppler Guide Wires.RANCHO CORDOVA, Calif.--(BW HealthWire)--Nov. 13, 1997-- EndoSonics Corporation (NASDAQ NASDAQ
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ESON Ethnobotanical Society of Nepal ), a leading developer and marketer of intravascular ultrasound and flow measurement products, today announced that it has received 510(k) marketing 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
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) for its FloWire(R) 300 and FloWire(R) 300 XT Doppler Guide wires for use with the Cardiometrics FloMap(R) Functional Assessment products.
EndoSonics markets a line of guide wire-based doppler ultrasound devices as part of its Cardiometrics product line, which was acquired in July 1997.
The FloWire 300 and the FloWire 300XT are designed to enable catheter exchanges during cardiovascular intervention, which allows for stent deployment and alternative balloon therapies.
Prior to this approval action, physicians were limited in their ability to change their therapeutic strategy in the middle of the procedure. This FDA action allows the physician to begin a procedure with one catheter, and then switch to a different catheter or stent during the procedure without removing the FloWire(R).
"The clearance of the FloWire 300 and FloWire 300XT in less than 90 days was a major achievement," said 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. "We believe that this product will provide significant benefit to the clinician in assessing the state of patient conditions and the result of therapeutic interventions, and will provide this information in a manner consistent with the current trend toward stent-based interventions.
"The recent approval by FDA of several intracoronary stents, and the published information on the utility of physiologic assessment during the placement of these devices, increases the importance of the ability to quickly obtain quantitative information from within the coronary vasculature vasculature /vas·cu·la·ture/ (vas´ku-lah-chur)
1. circulatory system.
2. any part of the circulatory system.
n. . The addition of these longer exchange length wire products is an important tool in the expansion of this technique."
EndoSonics develops, manufactures and markets intravascular ultrasound (IVUS IVUS Intravascular ultrasound, see there ) 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 by providing important diagnostic information not available from conventional x-ray angiography.
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 that measure blood flow impairment caused by 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. .
Cardometrics' principal 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 our Web site at 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 , form 10-Q, and the Registration Statement on Form S-4 filed with the Securities and Exchange Commission on June 13, 1997.
CONTACT: EndoSonics Corporation
Reinhard Warnking, 916/638-8008
Morgen-Walke Associates, Inc.
Doug Sherk/John Swenson, 415/296-7383
Sandra Badurina/Joshua Passman, 212/850-5600