News | March 23, 2010

FDA to Review Cryoablation System for Treatment of Paroxysmal AF

Medtronic's Arctic Front Cryocatheter System

March 18, 2010 — A cardiac cryoablation catheter system designed for patients with paroxysmal atrial fibrillation (PAF) has completed premarket approval and is under review by the U.S. Food and Drug Administration (FDA).

PAF is an irregular quivering of the upper chambers of the heart that starts and stops on its own. Atrial fibrillation (AF) is the most common heart arrhythmia in the United States, with an estimated three million patients suffering from this condition.

The premarket approval submission includes data from the STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) clinical trial presented last week at the 59th Annual Scientific Session of the American College of Cardiology (ACC). The clinical trial evaluated the safety and effectiveness of the Medtronic Arctic Front Cryocatheter System compared to anti-arrhythmic drug therapy.

The system is investigational and not currently available for sale in the United States. The device is limited by federal law to investigational use only.

For more information: www.medtronic.com

Related Content

The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
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...
Merge Hemo cath lab hemodynamics monitoring system.

Hemodynamic data shown on screens from the Merge Hemo recording system. It is among the newer generation hemodynamic systems for cath labs that are more user friendly and have technologies to speed workflow.

Feature | Hemodynamic Monitoring Systems| August 03, 2017 | Dave Fornell
The current generation of...
Left Atrial Pressure Monitor from Vectorious Medical Technologies Offers New Hope for Heart Failure Patients

On of the top stories in July was the introduction of a left atrial pressure monitor from Vectorious Medical Technologies to prevent heart failure patient hospitalizations or readmissions. Read the article"Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients."

Feature | August 01, 2017 | Dave Fornell
Aug.
Ohio State Researchers Prove Human Heart's 'Battery' Has Multiple Backups
News | EP Lab| July 27, 2017
July 27, 2017 — There is good news when it comes to the heart’s sinoatrial node (SAN), the body’s natural...
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...
Biotronik Launches DX Technology for U.S. Heart Failure Patients
News | Cardiac Resynchronization Therapy Devices (CRT)| July 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and availability of the Intica DX and Intica...
Cardiologs ECG Analysis Platform Receives FDA Clearance
Technology | ECG Monitoring Services| July 13, 2017
Cardiologs Technologies SAS announced that it has received U.S. Food and Drug Administration (FDA) clearance of its...
Overlay Init