News | April 08, 2007

FDA Panel Set to Evaluate CryoCor’s Cryoablation System

April 10, 2007 — CryoCor Inc., a medical device company focused on the treatment of cardiac arrhythmias, has announced it was informed by the FDA that the agency will convene an Advisory Panel meeting to review CryoCor's pre-market approval application, or PMA, for the treatment of atrial flutter. The Advisory Panel meeting is expected to be held in June or July 2007, and a decision from the FDA on CryoCor's PMA is expected in August 2007.

CryoCor reported that the chronic effectiveness of its cryoablation system, based upon a strict expert core lab analysis completed by an independent electrophysiologist, was statistically computed to be above 80 percent. An additional analysis performed utilizing a clinical assessment that CryoCor believes is comparable to the analysis from published literature demonstrates a chronic effectiveness above 90 percent.

CryoCor believes the use of an expert core lab to determine the chronic effectiveness is a more rigorous evaluation than has been completed in other clinical trials for the treatment of atrial flutter.

"I am happy to participate in the presentation of clinical data on behalf of CryoCor at the upcoming Advisory Panel meeting,” said Gregory Feld, M.D., principal investigator for CryoCor's atrial flutter pivotal trial. “I believe it is important to make this new medical technology available as an alternative to existing treatments, as there are specific atrial flutter patients that would benefit from cryoablation therapy."

For more information visit www.cryocor.com

Related Content

Stereotaxis Receives Regulatory Approval of e-Contact Module in Canada
Technology | Ablation Systems| December 08, 2017
December 7, 2017 — Stereotaxis Inc.
CardioFocus Announces European CE Mark Approval of HeartLight Excalibur Balloon
Technology | Ablation Systems| October 10, 2017
October 10, 2017 — CardioFocus Inc. recently announced the European CE Mark approval of the HeartLight Excalibur Ball
The Apama Radiofrequency (RF) Balloon Catheter System.
News | Ablation Systems| October 02, 2017
October 2, 2017 — Boston Scientific announced a definitive agreement to acquire Apama Medical Inc., a privately-held
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Medtronic Announces First Enrollments in STOP AF First Clinical Trial
News | Ablation Systems| July 24, 2017
Medtronic plc recently announced first enrollments in the STOP AF First clinical trial. The trial will evaluate the...
Biosense Webster multi-electrode RF ablation balloon

Biosense Webster's multi-electrode RF ablation balloon with irrigation. The system allows operators to change the energy levels of each electrode to avoid damaging sensitive underlying critical structures like the esophagus or phrenic nerve.

Feature | Ablation Systems| May 17, 2017 | Dave Fornell
May 17, 2017 – Clinical trial results from a first-in-human study evaluating the acute feasibility of an investigatio
Abbott Announces CE Mark for New Cardiac Ablation Catheter
News | Ablation Systems| May 10, 2017
Abbott announced CE Mark of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, developed to make it easier...
Medtronic, expanded indication, Freezor Xtra Cryoablation Catheter, AVNRT, atrioventricular nodal re-entrant tachycardia
Technology | Ablation Systems| February 16, 2017
Medtronic plc announced the U.S. Food and Drug Administration (FDA) has approved its Freezor Xtra Cryoablation Catheter...
CardioFocus, HeartLight Excalibur Balloon, 22nd Annual AF Symposium, atrial fibrillation, initial clinical evaluation
News | Ablation Systems| January 25, 2017
CardioFocus Inc. recently announced the initial clinical evaluation of the HeartLight Excalibur Balloon, a next-...
catheter ablations, atrial fibrillation, stroke risk, Intermountain Medical Center Heart Institute study, AHA Scientific Sessions, American Heart Association
News | Ablation Systems| November 14, 2016
Atrial fibrillation patients with a prior history of stroke who undergo catheter ablation lower their long-term risk of...
Overlay Init