CryoCor Completes Enrollment of Pivotal Clinical Study for Atrial Fibrillation
Ed Brennan, Ph.D. Chief Executive Officer of CryoCor, said, "This is amajor milestone for CryoCor, being the first company to complete enrollment ina randomized pivotal study for the use of ablation for the treatment of atrialfibrillation. Completion of enrollment confirms our lead over other companiesconducting atrial fibrillation ablation pivotal trials and brings us one stepcloser to our goal of bringing our product to market for the treatment ofatrial fibrillation. With the recent approval of our cryoablation system forthe treatment of right atrial flutter, in the fourth quarter, we will beginplacing our system at high volume ablation centers across the U.S.,familiarizing physicians with our system and establishing our installed baseof consoles in anticipation of approval for the treatment of atrialfibrillation in 2009."
Helen Barold, M.D. Chief Medical Officer of CryoCor, said, "I am verypleased with the progress we have made with this study and look forward tofully analyzing the data. We continue to see an excellent safety profile forour cryoablation device and expect to file a PMA in late 2008. At this pointwe will begin our non-randomized continued access protocol in which patientswill be enrolled into the ablation arm. "
CryoCor has enrolled over 170 patients in its pivotal clinical study andwill complete a 12-month follow up for each patient.
CryoCor is a medical technology company that has developed andmanufactures a disposable catheter system based on its proprietarycryoablation technology for the minimally invasive treatment of cardiacarrhythmias. The Company's product, the CryoCor Cardiac Cryoablation System,or the Cryoablation System, is designed to treat cardiac arrhythmias throughthe use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue.The Cryoablation System has been approved in Europe for the treatment ofatrial fibrillation, and atrial flutter, the two most common and difficult totreat arrhythmias, since 2002. In the United States, CryoCor is conducting apivotal trial to evaluate the safety and efficacy of the Cryoablation Systemfor the treatment of atrial fibrillation and the Cryoablation System has beenapproved for the treatment of right atrial flutter. For more informationplease visit the Company's website at http://www.cryocor.com
Forward Looking Statements
The statements in this press release that are not descriptions ofhistorical facts are forward-looking statements that are subject to risks anduncertainties. These include statements related to the Company's lead timeover other companies conducting atrial fibrillation ablation pivotal trials,ability of obtain FDA approval for and commercialize its product for thetreatment of atrial fibrillation and its timing for doing so, including itstiming for the filing the related PMA, and ability to, and the benefits from,placing its systems in high volume ablation centers in the U.S., all of whichare prospective. Such statements are only predictions and reflect CryoCor'sexpectations and assumptions as of the date of this press release based oncurrently available operating, financial, and competitive information. Theactual events or results may differ materially from those projected in suchforward-looking statements due to a number of factors, including risksinvolved with CryoCor's ability to obtain regulatory approval in the UnitedStates for its cryoablation system for use in treating atrial fibrillationwithin its anticipated timeframes, if at all; risks associated with theCompany's ability to submit a PMA for atrial fibrillation; risks associatedwith the Company's abilit
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