CARDIOMETRICS SUBMITS 510k FOR WAVEWIRE/WAVEMAP INTRAVASCULAR BLOOD PRESSURE MEASUREMENT SYSTEM.MOUNTAIN VIEW, Calif.--(HealthWire)--Dec. 30, 1996-- Cardiometrics, Inc. (Nasdaq: CFLO CFLO Central Florida Lyric Opera ), today announced the submission of a 510(k) Premarket Notification to the U.S. Food and Drug Administration for its WaveWire(TM)/WaveMap(TM) intravascular intravascular /in·tra·vas·cu·lar/ (in?trah-vas´ku-lar) within a vessel. in·tra·vas·cu·lar adj. Within one or more blood vessels. blood pressure measurement system. The WaveWire is the first true clinical angioplasty guide wire with pressure sensing capability. It features a 0.014-inch angioplasty guide wire with an electronic pressure sensor mounted 3 centimeters from the tip. The system allows analysis of not only mean pressures but also diastolic Diastolic The phase of blood circulation in which the heart's pumping chambers (ventricles) are being filled with blood. During this phase, the ventricles are at their most relaxed, and the pressure against the walls of the arteries is at its lowest. , systolic Systolic The phase of blood circulation in which the heart's pumping chambers (ventricles) are actively pumping blood. The ventricles are squeezing (contracting) forcefully, and the pressure against the walls of the arteries is at its highest. , and other important hemodynamic he·mo·dy·nam·ics n. (used with a sing. verb) The study of the forces involved in the circulation of blood. he parameters. Measurements are processed and displayed by the WaveMap pressure instrument, which has a compact design that easily integrates into the catheterization catheterization Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages. laboratory. Cardiometrics, based in Mountain View, Calif., develops, manufactures and markets intravascular medical devices 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. and other vascular diseases. Cardiometrics is pioneering on-line functional testing in the cardiac catheterization lab. The company's primary products are the FloWire(R) Doppler guide wire and FloMap(R) ultrasound instrument. WaveWire and WaveMap are trademarks and FloWire and FloMap are registered trademarks of Cardiometrics. -0- Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including clinical and payor acceptance of the Company's products, manufacturability of new products, timing of regulatory approvals, the impact of competitive products and other risks detailed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the year ended December 31, 1995 and the Company's Registration Statement on Form S-1 as declared effective by the Securities and Exchange Commission on November 1, 1995 (Reg. No. 33-96690). CONTACT: Communicore Barbara Kane, 714/721-8081 Barbara_Kane@Communicore.com or Cardiometrics Robert Y. Newell, IV, 415/961-6993, ext. 263 BobN@Cardiometrics.com |
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