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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