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:ESON - news), 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 (FDA) 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 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. 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) imaging systems and catheters to assist in the
diagnosis and treatment of cardiovascular and peripheral vascular disease. 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.
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 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, form 10-Q, and the Registration Statement on Form S-4 filed with the
Securities and Exchange Commission on June 13, 1997.
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