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

Boston Scientific, HeartLogic Heart Failure Diagnostic Service, MultiSENSE trial data, AHA Scientific Sessions 2016
News | Heart Failure| November 18, 2016
Boston Scientific recently announced results from the first clinical trial evaluating the performance of the HeartLogic...
atrial fibrillation, warfarin, dementia, Intermountain Medical Center Heart Institute, American Heart Association, AHA Scientific Sessions 2016
News | Atrial Fibrillation| November 15, 2016
Atrial fibrillation patients who use warfarin to lower risk of stroke are at higher risk of developing dementia than...
Medtronic, Claria MRI Quad CRT-D SureScan, FDA approval
Technology | Cardiac Resynchronization Therapy Devices (CRT)| November 15, 2016
Medtronic plc  has received U.S. Food and Drug Administration (FDA) approval for the Claria MRI Quad Cardiac...
catheter ablations, atrial fibrillation, stroke risk, Intermountain Medical Center Heart Institute study, AHA Scientific Sessions, American Heart Association
News | Ablation Systems| November 14, 2016
Atrial fibrillation patients with a prior history of stroke who undergo catheter ablation lower their long-term risk of...
Sponsored Content | Videos | Heart Valve Technology| November 14, 2016
William Abraham, M.D., FACC, discusses advances in heart failure device treatment technologies at the Transcatheter C
Siemens, FDA clearance, Xprecia Stride Coagulation Analyzer, point-of-care testing
Technology | Point of Care Testing| November 10, 2016
Siemens Healthineers announced U.S. Food and Drug Administration (FDA) 510(k) clearance for a hand-held portable...
genetic testing, sudden cardiac death of teen, Mayo Clinic Proceedings
News | Genetic Testing| November 09, 2016
The recent, sudden death of a 13-year-old boy resulted in more than 20 relatives being incorrectly diagnosed as having...
transcatheter aortic valve replacement, pacemakers, implantation, post-TAVR implantation, worse outcomes, study
News | EP Lab| November 09, 2016
Patients who undergo minimally invasive heart valve replacement, known as transcatheter aortic valve replacement (TAVR...
RFID inventory control in the cath lab, inventory management, cardinal

An example of RFID cabinets in a cath lab. As items are pulled from the cabinet, the inventory control system automatically determines what items were take out and adds them to the patient case. The system can also help locate recalled or expired items, and automatically track on-hand inventory to avoid manual counts.

Feature | Inventory Management| October 28, 2016 | Jean-Claude Saghbini
The healthcare industry’s transition to value-based care leaves no room for waste, and yet we know that inefficiency
Overlay Init