SAN DIEGO, Nov. 27 /PRNewswire-FirstCall/ -- CryoCor, Inc. , a medical device company focused on the treatment of cardiac arrhythmias, announced today the filing of its amendment to its pre-market approval application, or PMA, for the treatment of atrial flutter. CryoCor expects that the amendment filed with the U.S. Food and Drug Administration, or FDA, will require 180 days for its review.
Helen S. Barold, M.D., Chief Medical Officer of CryoCor said, “We believe our submission demonstrates the safety and effectiveness of our system for the treatment of atrial flutter. We have provided supplementary information that we believe supports the long-term chronic effectiveness of our cryoablation system. We look forward to working with the FDA in seeking approval to market our system in the United States for the treatment of atrial flutter.”
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, or the Cryoablation System, is designed to treat cardiac arrhythmias through the use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue. The Cryoablation System has been approved in Europe for the treatment of atrial fibrillation, or AF, and atrial flutter, or AFL, 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 Cryoablation System for the treatment of AF, and has submitted a PMA for the treatment of AFL. For more information please visit the Company’s website at http://www.cryocor.com
Forward Looking Statements
The statements in this press release that are not descriptions of historical facts are forward-looking statements that are subject to risks and uncertainties. These include statements included in this press release related to CryoCor’s amendment to its PMA for AFL including the expected time period for the FDA’s review of that amendment and the possibility of receiving approval for the treatment for AFL, all of which are prospective. Such statements are only predictions and reflect the Company’s expectations and assumptions as of the date of this press release based on currently available operating, financial, and competitive information. The actual events or results may differ materially from those projected in such forward-looking statements due to a number of factors, including risks involved with the CryoCor’s ability to obtain regulatory approval in the United States for its Cardiac Cryoablation System for use in treating AFL and AF within its anticipated timeframes, if at all; risks associated with the Company’s ability to successfully commercialize its Cardiac Cryoablation System in the United States and elsewhere if its Cardiac Cryoablation System is approved for use in the United States; risks associated with the Company’s dependence on patents and proprietary rights; risks associated with the Company’s protection and enforcement of its patents and proprietary rights; risks associated with the development or availability of competitive products or technologies; and the other risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. The Company expressly disclaims any intent or obligation to update any of these forward-looking statements.
Contact: CryoCor, Inc. Gregory J. Tibbitts Chief Financial Officer (858) 909-2200 gtibbitts@cryocor.com The Ruth Group Stephanie Carrington / Nick Laudico (investors) (646) 536-7017 / 7030 scarrington@theruthgroup.comnlaudico@theruthgroup.com Jason Rando (media) (646) 536-7025 jrando@theruthgroup.com
CryoCor
CONTACT: Gregory J. Tibbitts, Chief Financial Officer, CryoCor, Inc.,+1-858-909-2200, gtibbitts@cryocor.com; or Stephanie Carrington,+1-646-536-7017, scarrington@theruthgroup.com, or Nick Laudico, investors,+1-646-536-7030, nlaudico@theruthgroup.com, or Jason Rando, media,+1-646-536-7025, jrando@theruthgroup.com, all of The Ruth Group, forCryoCor, Inc.
Web site: http://www.cryocor.com/
