Feature | January 09, 2014

FDA Clears Topera’s Third-Generation 3D Mapping System

System identifies sources that sustain complex cardiac arrhythmias

topera 3-d 3d mapping system firmap rhythmview EP lab mapping fibrillation
January 9, 2014 — Topera Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for the latest generation of its 3D Mapping System. The workstation will be exhibited Jan. 9-11 at the Boston AF Symposium 2014 in Orlando, Fla.
 
The Topera 3D Mapping System consists of the RhythmView Workstation and FIRMap diagnostic catheter.
 
The system provides near-instantaneous intra-procedural mapping and re-mapping capabilities. In addition, the system incorporates a new color-imaging module to aid identification of rotors, an electrophysiological phenomenon previously shown to sustain atrial fibrillation (AF). These functionalities enable EPs to more efficiently diagnose complex arrhythmias.
 
“Atrial fibrillation is an incredibly challenging arrhythmia to treat, and the complexity of this disorder has defied interpretation and visualization by traditional EP mapping approaches,” said Eric Prystowsky, M.D., director of clinical electrophysiology, St. Vincent Hospital, Indianapolis. “Topera’s technology is the first to demonstrate an ability to reflect faithfully the complex mechanism(s) of this arrhythmia and provide a reliable way to visualize the tissue sources sustaining it.”
 
In addition to FDA 510(k) clearance for Topera’s 3D Mapping System, the company also obtained regulatory clearances and launched its proprietary FIRMap panoramic contact-mapping basket catheter in the United States and Europe in late 2013. FIRMap is the first and only contact-mapping basket catheter cleared by the FDA for use in all cardiac chambers to assist in the diagnosis of complex arrhythmias.
 
For more information: www.toperamedical.com, afsymposium.com

Related Content

Alere, INRatio PT/INR Monitor, voluntary recall, FDA
News | Blood Testing| July 12, 2016
July 12, 2016 — Following a collaborative process with the U.S. Food and Drug Administration (FDA), Alere Inc.
anticoagulants, dabigatran, Pradaxa, novel oral anticoagulants, NOACs, rivaroxaban, Xarelto, apixaban, Eliquis
Feature | Antiplatelet and Anticoagulation Therapies| July 12, 2016 | Heidi Olson, Pharm.D
With the recent introduction of several novel oral...
Abbott, FIRM-guided rotor ablation, atrial fibrillation, clinical studies, Cardiostim 2016
News | EP Mapping and Imaging Systems| July 07, 2016
July 7, 2016 — Abbott recently announced positive results from three clinical studies investigating the benefits asso
AtriCure, FROST cryoanalgesia study, William Beaumont Hospital Michigan, cryoICE system
News | Left Atrial Appendage (LAA) Occluders| July 07, 2016
AtriCure Inc. announced the first patient has been enrolled in the FROST study at William Beaumont Hospital, Dearborn,...
AtriCure, AtriClip PRO2 LAA Exclusion System, CE Mark, left atrial appendage occlusion
News | Left Atrial Appendage (LAA) Occluders| July 05, 2016
AtriCure Inc. announced that it has received CE Mark for the AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System...
News | Heart Failure| July 05, 2016
A research team has developed a new electric mesh device that can be wrapped around the heart to deliver electrical...
anabolic steroid abuse, ARVC, arrhythmia, stroke, British Cardiovascular Society conference
News | Cardiac Diagnostics| July 01, 2016
Research has already shown that taking anabolic steroids is associated with high blood pressure and an increased risk...
St. Jude Medical, CE Mark, SyncAV CRT, MultiPoint Pacing, CardioStim 2016
Technology | Cardiac Resynchronization Therapy Devices (CRT)| June 28, 2016
St. Jude Medical Inc. announced CE Mark approval and launch of SyncAV CRT software, designed to build upon the company’...
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Clinical Study| June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
atrial fibrillation, stroke risk, aspirin vs blood thinners, JACC study
News | Antiplatelet and Anticoagulation Therapies| June 24, 2016
More than 1 in 3 atrial fibrillation (AF) patients at intermediate to high risk for stroke are treated with aspirin...
Overlay Init