SAN DIEGO, Nov. 14 /PRNewswire-FirstCall/ -- CryoCor, Inc. , a medical device company focused on the treatment of cardiac arrhythmias, announced the results of an animal study comparing cryoablation and radiofrequency (RF) ablation being presented today at the 2005 Scientific Sessions of the American Heart Association. The study evaluated the potential to produce esophageal injury, a well-documented complication of atrial fibrillation ablation with RF, or heat-based energy.
The abstract, entitled “Comparison of RF and Cryoablation to produce esophageal injury when applied directly to the exterior of the bovine esophagus,” abstract 2360, is being presented on Monday, November 14, 2005 from 4:45 p.m. - 5:00 p.m. CST by Kenneth L. Ripley, CryoCor, Inc., San Diego, CA; Donald B. Olsen, Utah Artificial Heart Institute, Salt Lake City, UT; and John F. Van Vleet, Purdue University School of Veterinary Medicine, West Lafayette, IN. The published abstract of the presentation will be posted to CryoCor’s Web site at http://www.cryocor.com.
Over 20 incidences of esophageal fistulas, or open holes between the heart and the esophagus, have been reported in the medical literature as a result of left atrial RF ablation of patients with atrial fibrillation. This complication is life-threatening and can occur up to several weeks after the procedure. The presented study was designed to test the hypothesis that cryoablation, due to the way it affects the tissue, has a lower potential to cause this complication.
In the animal study, 47 lesions were made directly on the esophagus of 8 animals, 21 using cryoablation and 26 using RF ablation. The lesion sets were evaluated at one day following the ablation in half the study population, and evaluated at two weeks in the remaining population. Using CryoCor’s proprietary technology, cryoablation applied directly to the esophagus demonstrated dimensional and histological characteristics similar to RF ablation lesions. In the lesion sets evaluated at two weeks, fistula-like lesions developed in the esophageal wall in 2 of the 12 lesions produced as a consequence of RF ablation while no (0 of 14) fistula-like lesions developed as a result of cryoablation.
RF ablation destroys both the targeted cardiac tissue and the extracellular material that binds the cells together. By comparison, cryoablation, or the use of extreme cold, destroys cardiac cells and leaves the extra cellular structure surrounding the cells fully intact and thus reduces the complications associated with heat-based ablation. CryoCor believes this is the mechanism that accounts for the difference in fistula formation potential.
Gregory Ayers, Chief Executive Officer, said, “We were very pleased to see that the results from this animal study are suggestive of differences between the two energy modalities with respect to propensity to create fistulas. We believe that these data underpin why we have not seen esophageal fistulas in any patients treated for atrial fibrillation with our CryoCor Cardiac Cryoablation System.”
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 Cardiac Cryoablation 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 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 related to differences between cryoablation and RF ablation with respect to safety. 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 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 safety of the CryoCor Cardiac Cryoablation System for treating cardiac arrhythmias; 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 The Ruth Group Gregory J. Tibbitts Stephanie Carrington / Nick Laudico (investors) Chief Financial Officer (646) 536-7017 / 7030 (858) 909-2200 scarrington@theruthgroup.comgtibbitts@cryocor.comnlaudico@theruthgroup.com Jason Rando (media) (646) 536-7025 jrando@theruthgroup.com
CryoCor, Inc.
CONTACT: Gregory J. Tibbitts, Chief Financial Officer of CryoCor,+1-858-909-2200, gtibbitts@cryocor.com; or Investors - StephanieCarrington, scarrington@theruthgroup.com, +1-646-536-7017, or Nick Laudico,nlaudico@theruthgroup.com, +1-646-536-7030; or Media - Jason Rando,+1-646-536-7025, jrando@theruthgroup.com, all of The Ruth Group, forCryoCor, Inc.
Web site: http://www.cryocor.com/
