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Strategies & Market Trends : Joe Copia's daytrades/investments and thoughts -- Ignore unavailable to you. Want to Upgrade?

To: Fitz who wrote (6138)	7/8/1998 11:19:00 AM
From: Wayne Rumball	Respond to of 25711

I guess the people that understand this think it is a good thing; FREMONT, CALIF. (July 8) BW HEALTHWIRE -July 8, 1998--Cardima, Inc. (NASDAQ:CRDM) today announced that the United States Food and Drug Administration (FDA) 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 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 of the heart during x-ray. The VUEPORT enables physicians to rapidly produce a venogram, 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 (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 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 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.