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

Medtronic Cryoballoon Improves Quality of Life, Reduces Systems of Persistent Atrial Fibrillation
News | Ablation Systems | August 28, 2018
Medtronic plc announced new findings from the CRYO4PERSISTENT AF clinical trial demonstrating improved quality of life...
Thermedical Announces FDA IDE Approval for Clinical Study of Durablate Catheter
News | Ablation Systems | August 02, 2018
Thermedical announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device...
Boston Scientific to Acquire Cryterion Medical Inc.
News | Ablation Systems | July 13, 2018
Boston Scientific Corp. recently announced a definitive agreement to acquire Cryterion Medical Inc., a privately-held...
Treating AFib With Ablation Reduces Mortality and Stroke
News | Ablation Systems | July 05, 2018
Using catheter-based ablation instead of medications alone reduces the risks of death and stroke in patients with the...
LuxCath Showcases OmniView Light-Guided Ablation Catheter at HRS 2018
News | Ablation Systems | May 22, 2018
LuxCath LLC showcased the next generation of its proprietary OmniView light-guided catheter ablation system at the 2018...
The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously.  #HRS2018

The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously. 

News | Ablation Systems | May 21, 2018
May 21, 2018 — Complete pulmonary vein isolation (PVI) was achieved in more than 99 percent of patients in a first-in
CardioFocus Announces Successful Live Case Featuring HeartLight X3 System
News | Ablation Systems | May 17, 2018
Medical device manufacturer CardioFocus Inc. announced a successful live case featuring its HeartLight X3 System during...
Imricor MRI-Guided Cardiac Ablation Study Results to Be Presented at HRS 2018
News | Ablation Systems | May 10, 2018
Results from the clinical study to evaluate Imricor’s Vision-MR Ablation Catheter for the treatment of atrial flutter...
Biosense Webster Launches Carto Vizigo Bi-Directional Guidance Sheath
Technology | Ablation Systems | May 08, 2018
Biosense Webster Inc. announced its Carto Vizigo Bi-directional Guiding Sheath is now available in the United States....
Stereotaxis and Acutus Medical Announce Strategic Collaboration
News | Ablation Systems | May 04, 2018
Stereotaxis and Acutus Medical announced a strategic collaboration to integrate the Stereotaxis Niobe Magnetic...
Overlay Init