Technology | January 18, 2013

FDA Clears nContact’s Cardiac Ablation Device, EPi-Sense With Embedded Sensors

Innovation allows physicians to direct epicardial ablation on atrium and create lesions on ventricle

EPi-Sense Guilded Coagulation Device nContact VisiTrax

January 18, 2013 — nContact Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s modifications to its VisiTrax cardiac ablation device, EPi-Sense, now with embedded sensing capability. This next generation of technology includes sensors along the ablation device, which provide real-time feedback to physicians conducting cardiac ablation procedures.

The EPi-Sense device and its sensing technology allows electrophysiologists (EPs) to follow epicardial device positioning and lesion creation in real time by utilizing navigational mapping. From a safety perspective, the sensors use electrical feedback to ensure the device is properly positioned on cardiac tissue and energy is directed into the heart. Additionally, by using the sensors during epicardial ablation, the ablated tissue’s electrical impulses can be measured to predict lesion completeness before repositioning the device.

“The EPi-Sense is another step forward in advancing epicardial ablation techniques to address limitations of other ablation devices, potentially creating a better experience for physicians, and ultimately, patients,” commented John Funkhouser, president of nContact Inc.

“Throughout the company’s short history, their engineers have consistently innovated and improved devices for epicardial ablation, especially for the treatment of arrhythmias in patients with enlarged and diseased atria. This has allowed physicians and surgeons to work together to address and treat arrhythmias in patients with the most complex heart disease,” said Paul Mounsey, M.D., professor and Director of Electrophysiology at the University of North Carolina-Chapel Hill.

nContact will have the EPi-Sense device available for review at the Boston Atrial Fibrilliation Symposium Jan. 17-19, 2013, in Boston, Mass., at booth number 501. Commercial release of the device is scheduled for early 2013.

For more information: www.ncontactinc.com.

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...
LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

Feature | Left Atrial Appendage (LAA) Occluders| September 07, 2017
September 7, 2017 — Closure of the left atrial appendage (LAA) during heart surgery protects the brain, according to
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.
Real-World Analysis Compares Safety, Effectiveness of Apixaban Versus Warfarin
News | Antiplatelet and Anticoagulation Therapies| August 28, 2017
August 28, 2017 — Bristol-Myers Squibb Company and Pfizer Inc.
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
Overlay Init