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: www.accessdata.fda.gov

Related Content

News

July 14, 2025  –  Johnson & Johnson MedTech has announced U.S. Food and Drug Administration (FDA) approval of an update ...

Home July 14, 2025
Home
News

July 7, 2025 — Catheter ablation is a minimally invasive treatment for abnormal heart rhythms. It is often successful in ...

Home July 09, 2025
Home
News

June 4, 2025 — A new study published in The Annals of Thoracic Surgery, a journal from The Society of Thoracic Surgeons ...

Home June 04, 2025
Home
News

April 24, 2025 – The Heart Rhythm Society (HRS) and the American College of Cardiology (ACC) have released a scientific ...

Home April 24, 2025
Home
News

April 9, 2025 — Merit Medical Systems has announced the U.S. commercial release of its Ventrax Delivery System. Ventrax ...

Home April 16, 2025
Home
News

March 27, 2025 — Abbott recently announced it has received CE Mark in Europe for the Volt PFA System to treat patients ...

Home March 27, 2025
Home
News

Oct. 24, 2024 — Medtronic plc has announced United States Food and Drug Administration (FDA) approval of the Affera ...

Home October 30, 2024
Home
News

Oct. 18, 2024 — Boston Scientific Corp. recently announced it has received U.S. Food and Drug Administration (FDA) ...

Home October 21, 2024
Home
News

May 15, 2024 —CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for cardiac ...

Home May 15, 2024
Home
News

May 13, 2024 — Innovative Health, Inc. announced that recent growth in single-use device reprocessing has delivered ...

Home May 13, 2024
Home
Subscribe Now