CARDIMA COMPLETES ATRIAL FIBRILATION TREATMENT TRIAL.Cardima, Inc. (Nasdaq:CRDM CRDM Control Rod Drive Mechanism CRDM Centre for Rapid Design and Manufacture (Buckinghamshire Chilterns University) CRDM Cumann Rince Dea Mheasa (Irish dancing organisation) ), Fremont, Calif., has announced the successful completion of its ten-patient feasibility trial to treat atrial fibrillation (AF) in the United States. The trial took place at Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world , Johns Hopkins Hospital
Phil Radlick, Ph.D., 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 Cardima, said "We are pleased with the results of this trial. We continue to progress in meeting key milestones including our European clinical trial completion and subsequent CE Mark approval in Europe for treating AF and the completion of our feasibility trial in the U.S. We plan to submit this data to the U.S. Food and Drug Administration (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. ) in the fourth quarter for approval to expand the pivotal phase of this clinical trial. We expect to conduct this trial at approximately ten centers throughout the U.S." "People suffering from AF currently have options," Dr. Radlick continued, "but there are side effects and significant costs associated with these options." Anti-arrhythmic drugs and defibrillators don't cure the disease, and the Maze procedure, an open-heart operation, cures but is very invasive and all these options are very costly. Catheter ablation offers patients a minimally invasive, cost effective procedure that has been proven and approved in treating other heart rhythm disorders such as supraventricular tachycardia (SVT SVT supraventricular tachycardia. SVT abbr. supraventricular tachycardia SVT Supraventricular tachycardia, see there ). The number of patients with AF grows as the population ages and there are already over two million people with AF in the United States alone." 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 microcatheters to be used in diagnosing and treating VT from within the wall of the heart. For further information about atrial fibrillation and ventricular tachycardia, contact Cardima's website at www.cardima.com. For more information, call 510/354-0162. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion