News | August 02, 2007

FDA Clears CryoCor’s Cryoablation Device

August 3, 2007 - CryoCor Inc., a medical device company focused on the treatment of cardiac arrhythmias, announced today that the FDA has granted pre-market approval (PMA) for its Cardiac Cryoablation System for the treatment of right atrial flutter, enabling CryoCor to target over 200,000 U.S. patients treating flutter with cryoablation annually.

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.

For more information: www.cryocor.com

Related Content

Biosense Webster Announces Initial Results From First-in-Human QDOT-FAST Study
News | Ablation Systems | May 16, 2019
Johnson & Johnson Medical Devices Companies announced that Biosense Webster, Inc.’s QDot Micro catheter...
CardioFocus Announces Results From HeartLight X3 Ablation System Pivotal Study
News | Ablation Systems | May 16, 2019
CardioFocus Inc. announced the presentation of results from its pivotal confirmatory study evaluating the HeartLight X3...
New Global Consensus Statement Addresses Catheter Ablation of Ventricular Arrhythmias
News | Ablation Systems | May 14, 2019
The Heart Rhythm Society (HRS) in partnership with three other professional societies issued an international consensus...
Netherlands Hospital to Install State-of-the-Art MRI Ablation Center
News | Ablation Systems | May 13, 2019
Imricor announced the signing of a commercial agreement with the Haga Hospital in The Hague, Netherlands to outfit a...
A CyberHeart cardiac ablation radiotherapy treatment plan showing where the radiation beam will ablate for a noninvasive pulmonary vein isolation procedure. Varian acquires, buys, purchases Cyberheart.

A CyberHeart cardiac ablation radiotherapy treatment plan showing where the radiation beams will ablate for a noninvasive pulmonary vein isolation procedure to treat an arrhythmia.

Feature | Ablation Systems | May 10, 2019 | Dave Fornell, Editor
May 10, 2019 — Radiation oncology vendor Varian announced it acquired the start-up company CyberHeart, which has deve
Ablation Reduces Risk of Dementia in Patients With AFib and Carotid Artery Disease
News | Ablation Systems | May 08, 2019
Even though many medical practitioners may opt not to perform procedures on higher-risk patients, new research finds it...
CardioFocus Announces European CE Mark Approval Of HeartLight X3 System
News | Ablation Systems | April 16, 2019
CardioFocus Inc. announced the European CE Mark approval of the HeartLight X3 Endoscopic Ablation System.
First Patient Treated With QDot Micro Ablation Catheter
News | Ablation Systems | February 04, 2019
Biosense Webster has enrolled and treated the first patient in its U.S. Investigational Device Exemption (IDE) study...
FDA Approves TactiCath Contact Force Ablation Catheter, Sensor Enabled
Technology | Ablation Systems | January 21, 2019
Abbott announced U.S. Food and Drug Administration (FDA) approval of the TactiCath Contact Force Ablation Catheter,...
First Patient Treated in STELLAR Atrial Fibrillation IDE Study
News | Ablation Systems | November 30, 2018
Johnson & Johnson Medical Devices Companies announced that Biosense Webster Inc. has enrolled and treated the first...
Overlay Init