Navigation Links
CryoCor Receives FDA Approval for Right Atrial Flutter
Date:8/19/2007

SAN DIEGO, Aug. 2 /PRNewswire-FirstCall/ -- CryoCor, Inc. (Nasdaq: CRYO), a medical device company focused on the treatment of cardiac arrhythmias, announced today that the U.S. Food and Drug Administration (FDA) has granted pre-market approval (PMA) for its Cardiac Cryoablation System for the treatment of right atrial flutter.

Based on this approval, CryoCor intends to begin selling its cryoablation system in the United States over the next several months. The Company will place an initial focus on console placement in high-volume ablation centers in the U.S. and is currently evaluating its sales and marketing requirements for this strategy. The Company has targeted an initial installed base of approximately 120 to 160 consoles by December 31, 2008, growing to approximately 300 consoles by 2010.

Helen Barold, M.D., Chief Medical Officer of CryoCor, said, "I am extremely pleased with the FDA's decision to approve our Cryoablation System for the treatment of right atrial flutter. There is a large opportunity for treating flutter with cryoablation. Over 200,000 patients per year in the United States are diagnosed with this condition. Many of these patients could benefit from the unique advantages provided by our system, specifically the fact that cryoablation is a less painful way of ablating right atrial flutter as demonstrated by several published studies. "

Ed Brennan, Ph.D., President and Chief Executive Officer of CryoCor, said, "The approval of the PMA for the CryoCor Cryoablation System for the treatment of right atrial flutter by the FDA is a major milestone for the company. We look forward to commencing our sales and marketing efforts and driving utilization of our Cryoablation System. An important element of our strategy is to grow our installed base of consoles, which drives the use of disposables for the treatment of right atrial flutter."

The FDA's decision to approve CryoCor's PMA for right atrial flutter follows an Advisory Panel meeting convened on June 27, 2007. At that panel meeting, the Advisory Panel voted to recommend approval of CryoCor's PMA, with conditions. To comply with these conditions, CryoCor will implement a formal training program for clinical sites, as well as conduct a two-arm registry study of 650 patients collecting safety and long term effectiveness data on the use of its cryoablation system as compared to approved radiofrequency catheters in the treatment of right atrial flutter. CryoCor reported that it does not anticipate significant difficulty in complying with the requirements of the registry study.

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, 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 Cryoablation System for the treatment of atrial fibrillation and the Cryoablation System has been approved for the treatment of right 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. 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 associated with the Company's ability to successfully commercialize its Cryoablation System in the United States and elsewhere; 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.

Contacts:

CryoCor The Ruth Group

Gregory J. Tibbitts Nick Laudico / Zack Kubow (investors)

Chief Financial Officer (646) 536-7030 / 7020

(858) 909-2200 nlaudico@theruthgroup.com

gtibbitts@cryocor.com zkubow@theruthgroup.com

Jason Rando (media)

(646) 536-7025

jrando@theruthgroup.com


'/>"/>
SOURCE CryoCor, Inc.

Copyright©2007 PR Newswire.

Related medicine technology :

1. Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection
2. Protalix BioTherapeutics, Inc. Receives Approval from the FDA to Initiate a Phase III Clinical Trial of prGCD
3. DUSA Pharmaceuticals Receives Orphan Drug Desi gnation for Levulan PDT to Treat Esophage al Dysplasia
4. Gloucester Pharmaceuticals Receives Fast Track Designation for Romidepsin in Peripheral T-Cell Lymphoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/13/2017)... 2017  New York City-based market research firm Kalorama Information ... aware of.  From new products to new costs, to the ... recently completed study, Potential Pipeline Disruptors . ... 1.  Age-Driven Growth - True Impact Moment Arriving ... the impact the growing population and, to a more extreme ...
(Date:7/11/2017)... ROCKVILLE, Md. , July 11, 2017  The ... had estimated revenues of approximately $394.1 million in 2016.  ... a trend of solid growth, in particular as a ... oncology clinical practice, and the recent introduction of a ... the need for less-invasive testing of tumor biomarkers to ...
(Date:7/10/2017)... GAITHERSBURG, Md. , July 10, 2017 ... in non-animal test methods, is the recipient of a ... by the PETA International Science Consortium. The device, which ... be used to expose human lung cells to airborne ... lung. IIVS will use the VITROCELL® system for testing ...
Breaking Medicine Technology:
(Date:7/21/2017)... ... 21, 2017 , ... The Margarian Law Firm has filed a class ... ale for allegedly containing no ginger. Dr. Pepper produces the “Canada Dry” brand of ... Margaryan alleges Canada Dry Ginger Ale claims on its bottle that it is made ...
(Date:7/21/2017)... ... July 21, 2017 , ... “Kids aren't born knowing how to ... shoes,” says Suzanne Tucker, Founder of St. Louis-based positive education company Generation Mindful. To ... Kickstarter on Monday, July 21st. , The kit uses colorful, engaging and educational ...
(Date:7/21/2017)... CANADA (PRWEB) , ... July 21, 2017 , ... ... torn anterior cruciate ligament (ACL) offer patients improved quality of life five years ... for Sports Medicine’s Annual Meeting in Toronto, Ontario, Canada. The study followed ...
(Date:7/20/2017)... Boston, MA (PRWEB) , ... July 20, 2017 ... ... aggressive form of blood and bone marrow cancer that progresses rapidly without treatment. ... often recommended to reduce the chance of reoccurrence and relapse. With such ...
(Date:7/20/2017)... ... July 20, 2017 , ... ... in which their iMedSecure™ comes included with each system installation. RMT’s iMedHD2™ ... to remote participants for real-time collaboration and immediate decision-making requirements. While never ...
Breaking Medicine News(10 mins):