Cardima Receives Approval in Canada to Market Revelation Family of Microcatheters to Treat Atrial Fibrillation.
Business Editors & Health/Medical Writers
FREMONT, Calif.--(BUSINESS WIRE)--Jan. 8, 2003
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) ) today announced that the Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. of Health Canada has approved a license to market Cardima's REVELATION(R) family of ablation microcatheters for the treatment of atrial fibrillation atrial fibrillation
Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. (AF). The license covers the REVELATION Tx, REVELATION T-Flex and REVELATION Helix.
"With approval of these catheters, Canadian electrophysiologists will have the minimally invasive tools to create straight, curved and circumferential linear endocardial endocardial /en·do·car·di·al/ (-kahr´de-al)
1. situated or occurring within the heart.
2. pertaining to the endocardium.
1. situated or occurring within the heart.
2. lesions to treat AF by replicating the surgical Maze procedure maze procedure Cox procedure Heart surgery A procedure used to manage A Fib. See Atrial fibrillation. Cf Corridor procedure. ," stated Gabriel Vegh, chief executive officer of Cardima. "We continue to see a growing interest in the need for novel therapeutic products to treat AF in many markets."
In November 2002, Cardima received a notice of acceptance by the U.S. Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) of its pre-market approval (PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.
PMA Progressive muscular atrophy ) application for the REVELATION Tx microcatheter system and expedited review status.
Cardima, Inc. developed the REVELATION(R) Tx linear ablation microcatheter system as a minimally invasive, single-use product that may have the potential for curing AF. In the United States, Cardima believes the REVELATION(R) Tx to be the first device to treat AF that has been submitted on a PMA application to the FDA. Cardima submitted the PMA on September 20, 2002 and was granted expedited review status by the FDA on November 5, 2002. Clinical trial data from the REVELATION(R) Tx microcatheter demonstrated safety and promising efficacy. Cardima's mission is to get better devices to treat AF in the hands of the medical community.
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 the Company's ability to raise additional capital, whether the Company's premarket approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device. application will be approved by the U.S. FDA, and whether the Company will be able to conduct successful clinical trials, obtain regulatory approvals and gain acceptance from the marketplace for its products. Additional risks are set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2001, filed with the Securities and Exchange Commission on April 1, 2002, and the Company's Quarterly Reports on Form 10-Q for the Quarters ended March 31, June 30, and September 30, 2002. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.