Topera Gains FDA Clearance for Third Generation of 3-D Mapping System

Palo Alto, Calif.-based Topera Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the latest generation of its 3-D mapping system.

“Topera pioneered the field of advanced electrophysiologic mapping with the introduction of our 3-D mapping system in 2011,” said Edward Kerslake, CEO of Topera. “We remain committed to building upon this platform to further aid electrophysiologists (EPs) in diagnosing complex arrhythmias and allowing them to tailor therapies to deliver improved clinical outcomes for their patients.”

The new system is touted to process information in seconds to provide intra-procedural mapping and
re-mapping capabilities. In addition, the system incorporates a new color-imaging module to aid identification of rotors, an electrophysiologic phenomenon previously shown to sustain atrial fibrillation. These functionalities are hoped to 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, clinical electrophysiology at St. Vincent Hospital in Indianapolis, Ind. “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 cleared by the FDA for use in all cardiac chambers to assist in the diagnosis of complex arrhythmias.

Topera is a venture capital-backed company, and has developed a suite of devices for the identification of sources that sustain complex cardiac arrhythmias.