Technology | January 23, 2014

FDA Clears Flexible EP Ablation Catheter

Irvine Biomedical Therapy Cool Flex Ablation Catheter St. Jude Medical
January 23, 2014 — The U.S. Food and Drug Administration (FDA) gave market clearance to Irvine Biomedical Inc., a St. Jude Medical company, for its Therapy Cool Flex Ablation Catheter and IBI 1500T9-CP v.1.7 Cardiac Ablation Generator. 
The Therapy Cool Flex is a steerable, deflectable, irrigated catheter used to treat atrial flutter by finding the rhythm disturbance source and ablating small areas of the heart tissue. The catheter takes energy from an external source, the IBI1500T9-CP V1.7 Cardiac Ablation Generator, to a point in the right side of the heart. 
The pattern of the ablation catheter laser-cut electrode tip allows flexibility and provides a more uniform distribution of saline fluid to the ablation site.
Cardiac catheter ablation can cure typical atrial flutter and restore a normal heart rhythm. In other cases, it can reduce the frequency of episodes a patient experiences. In a clinical study involving 179 patients, the abnormal rhythm was corrected in 177 patients (98.8 percent) at least 30 minutes after treatment, and it remained corrected after 3 months in 150 patients.
The device is contra-indicated in patients who have an active systemic infection, a blood clot attached to the inside of the heart or an incision in the atrium or ventricle from within the last four weeks.
For more information:

Related Content

Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Technavio Projects 9 Percent Global Growth for Electrophysiology Therapeutic Devices

Image courtesy of Technavio

News | EP Lab| September 11, 2017
September 11, 2017 — According to the latest market study released by Technavio, the global...
EMANATE Trial Shows Apixaban Lowers stroke in AF Patients Undergoing Cardioversion.
News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Apixaban lowers the risk of stroke compared to warfarin in anticoagulation-naïve patients with at
CASTLE-AF Study shows Catheter Ablation of Atrial Fibrillation is First-Line Treatment for Heart Failure Patients. Biotronic Ilivia 7 ICD.

The CASTLE-AF Study shows catheter alation of AF can be used effectively to treat heart failure in patients with an implanted ICD.

News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Final results from the CASTLE-AF study show a 38 percent reduction in the composite of all-cause
Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices

Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices.

Feature | EP Lab| August 29, 2017 | Dave Fornell
August 29, 2017 — The U.S.
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
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...
Overlay Init