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Cardima Announces FDA Clearance for Vueport Balloon Occlusion Guiding Catheter.


FREMONT, Calif.--(BW HealthWire)--July 8, 1998--Cardima, Inc. (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
:CRDM CRDM Control Rod Drive Mechanism
CRDM Centre for Rapid Design and Manufacture (Buckinghamshire Chilterns University)
CRDM Cumann Rince Dea Mheasa (Irish dancing organisation) 
) today announced that 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.
) has granted 510(k) clearance to market Cardima's proprietary VUEPORT(TM) balloon occlusion guiding catheter. The VUEPORT is the only guiding catheter with a compliant balloon on its distal tip, designed to allow access and enhance visualization of the coronary venous system for mapping of ventricular tachycardia (VT).

The VUEPORT Guiding Catheter is specially designed to temporarily occlude (programming) occlude - (Or "shadow") To make a variable inaccessible by declaring another with the same name within the scope of the first.  the coronary sinus, which is the main venous, or draining blood vessel in the heart, allowing the physician to inject radiopaque dye which will show the vasculature vasculature /vas·cu·la·ture/ (vas´ku-lah-chur)
1. circulatory system.

2. any part of the circulatory system.


vas·cu·la·ture
n.
 of the heart during x-ray. The VUEPORT enables physicians to rapidly produce a venogram ve·no·gram
n.
1. A radiograph of a vein after injection of a radiopaque substance.

2. See phlebogram.



venogram

1. phlebogram.

2. venous-pulse tracing.
, or picture of the heart's veins and guides the physician in the delivery of other diagnostic microcatheters or placement of pacing leads. This may reduce patient exposure to fluoroscopy fluoroscopy /flu·o·ros·co·py/ (fldbobr-ros´kah-pe) examination by means of the fluoroscope.

fluo·ros·co·py
n.
Examination by means of a fluoroscope. Also called radioscopy.
 (x-ray), reduce procedure time and potentially reduce costs.

The VUEPORT guiding catheter is the latest addition to Cardima's portfolio of guiding catheters and includes various curve shapes which are designed to match patient specific anatomy similar to Cardima's VENAPORT(TM) family of guiding catheters.

"The introduction of the VUEPORT guiding catheter for occlusive occlusive /oc·clu·sive/ (o-kloo´siv) pertaining to or causing occlusion.

oc·clu·sive
adj.
1. Occluding or tending to occlude.

2.
 venograms, coupled with our Cardima PATHFINDER(TM) microcatheter series for mapping VT, significantly strengthens Cardima's position in the electrophysiology market," said Phillip Radlick, Ph.D., President and Chief Executive Officer of Cardima. "The name of the game in treating VT is access and the VUEPORT guiding catheter makes access easier. The VUEPORT paves the way for the introduction of our other advanced and innovative systems for the diagnosis and eventual treatment of VT and AF, two of the largest unmet clinical needs in cardiovascular medicine."

Cardima, Inc. designs, develops, manufactures and markets minimally invasive, single-use microcatheter-based systems for the dual purpose of finding and treating the two most common forms of cardiac arrhythmias: atrial fibrillation, a condition of the heart characterized by the irregular and very rapid beating of the heart's atrial atrial /atri·al/ (a´tre-al) pertaining to an atrium.

a·tri·al
adj.
Of or relating to an atrium.


Atrial
Having to do with the upper chambers of the heart.
 chambers, and ventricular tachycardia, a life-threatening condition in which heartbeats are improperly initiated from within the ventricular walls, bypassing the heart's normal conduction system. Cardima is the only company developing unique microcatheter systems to be used in both diagnosing and treating AF and VT. For further information about atrial fibrillation and ventricular tachycardia, contact Cardima's website at www.cardima.com.

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, without limitations, those set forth in the Company's Registration Statement on Form S-1 and periodic reports filed with the Securities and Exchange Commission, and the Company's ability to conduct successful clinical trials, obtain timely regulatory approvals and gain acceptance from the marketplace for its products.

    CONTACT: Cardima, Inc.
              Ron Bourquin, 510/354-0162
              http://www.cardima.com


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Copyright 1998, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
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Geographic Code:1USA
Date:Jul 8, 1998
Words:491
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