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CRYOCOR SUBMITS PMA FOR ATRIAL FLUTTER SUBMISSION.

CryoCor, Inc. (NASDAQ:CRYO), San Diego, Calif. has submitted the fourth and final module of the Premarket Approval (PMA) Application relating to the use of its Cardiac Cryoablation System for the treatment of Atrial Flutter to the FDA. The final module contains the clinical safety and efficacy data from a multi-center clinical trial. During the clinical trial, 160 patients with Atrial Flutter were treated using the CryoCor Cardiac Cryoablation System at 22 clinical sites between December 2003 and November 2004. All patients were evaluated for six months following completion of the procedure. The filing of the PMA is the first step in the review process for a PMA and does not indicate the PMA will be accepted by the FDA, and does not guarantee that the PMA will ultimately be approved by the FDA.

"This is a critical step for us in the process of working with the FDA to secure the ability to market our system in the U.S.," stated Dr. Gregory Ayers, CryoCor founder and CEO.

Atrial Flutter is the second most common supra-ventricular tachycardia, or SVT, and estimates are that 200,000 new cases occur each year in the United States alone. Atrial Flutter is a complex, organized arrhythmia that increases the risk of stroke as a result of blood clot formation in the heart, and in some cases, may convert to Atrial Fibrillation, the most common SVT.

About CryoCor

CryoCor is a medical technology company that has developed and manufactures a disposable catheter system based on its proprietary cryoablation technology for the minimally invasive treatment of cardiac arrhythmias. The company's product, the CryoCor Cardiac Cryoablation System, is designed to treat cardiac arrhythmias through the use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue. The CryoCor System has been approved in Europe for the treatment of Atrial Fibrillation and Atrial Flutter, the two most common and difficult to treat arrhythmias, since 2002. In the United States, CryoCor is conducting a pivotal trial to evaluate the safety and efficacy of the CryoCor Cardiac Cryoablation System for the treatment of atrial fibrillation, and has submitted a PMA for the treatment of Atrial Flutter.

For more information, visit http://www.cryocor.com or call 858/909-2252.
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Publication:Biotech Equipment Update
Date:Sep 1, 2005
Words:369
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