Feature | February 06, 2014| Dave Fornell

New EP Mapping Systems Enter the U.S. Market

Systems offer Improved Speed and Accuracy

New electrophysiology (EP) ablation mapping/navigation systems recently entered the U.S. market, each offering technology the vendors say will speed procedure time and improve procedural accuracy.
 
Boston Scientific’s Rhythmia Mapping System, a 3-D mapping and navigation system, gained U.S. Food and Drug Administration (FDA) 510(k) clearance in 2013. It is designed to intelligently automate map creation, increase speed and improve the density of mapping, capturing thousands versus hundreds of data points. The system also features vMap, a validation map, which is designed to enable EPs to rapidly confirm the endpoints of the ablation treatment. The intelligence built into the system also helps eliminate the need for manual annotation.
 
The Rhythmia mapping system works with Boston Scientific’s 64-electrode IntellaMap Orion high-resolution mapping catheter.
 
FIRM Rotor Mapping
Atrial fibrillation has proved to be an incredibly challenging arrhythmia to treat, and its complexity has defied interpretation and visualization by traditional EP mapping approaches. A relatively new technique has been developed using basket-mapping catheters to directly image myocardial bio-electrical rotors, an EP phenomenon shown in clinical studies to sustain atrial fibrillation.
 
Topera Inc. received 510(k) clearance in December for the latest generation of its 3D Mapping System. The new system has faster processing times, providing near-instantaneous intra-procedural mapping and re-mapping capabilities. The system incorporates a new color-imaging module to aid identification of rotors, an EP phenomenon previously shown to sustain atrial fibrillation. These functionalities enable EPs to more efficiently diagnose and ablate the cause of these complex arrhythmias.
 
Topera also gained approval for its FIRMap panoramic contactmapping 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. 

Related Content

EpiAccess System, EpiEP, Mount Sinai New York, epicardial access
News | Ablation Systems| August 22, 2016
August 22, 2016 — The Mount Sinai Hospital is the first site in the New York metropolitan area to pioneer a new appro
warfarin, long-term stability, atrial fibrillation, DCRI study, Sean Pokorney
News | Antiplatelet and Anticoagulation Therapies| August 16, 2016
August 16, 2016 — Warfarin prescribed to prevent strokes in...
Sponsored Content | Videos | Inventory Management| August 15, 2016
Pacemakers, stents and bandages — keeping tracking of what is on hand and accurately capturing charges can be a chall
News | EP Lab| August 12, 2016
August 12, 2016 — Electrophysiology ablation navigation system company Stereotaxis Inc.
Absorb, bioresorbable stent, FDA approval, FDA approves, FDA clears, most popular content, most popular stories, DAIC

The FDA clearance of the first bioresorbable stent, the Abbott Absorb, the first week of July has been the most popular story so far for all of 2016. It is the first fully dissolving stent approved for the U.S. market and many experts say this technology could be a paradigm shift in coronary and peripheral therapies in the coming years as the technology improves. 

Feature | August 05, 2016 | Dave Fornell
 
Watchman, left atrial appendage closure, LAA occluder

An illustration of a Watchman transcatheter LAA occluder being implanted.

Feature | Left Atrial Appendage (LAA) Occluders| August 01, 2016 | Dave Fornell
Patients with atrial fibrillation (AF or Afib) are high risk for stroke due to the formation of thrombus emboli in th
pros and cons of new anticoagulation therapies, anticoagulants, dabigatran, Pradaxa, novel oral anticoagulants, NOACs, rivaroxaban, Xarelto, apixaban, Eliquis
Feature | Antiplatelet and Anticoagulation Therapies| July 26, 2016 | Heidi Olson, Pharm.D
With the recent introduction of several novel oral...
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.
Overlay Init