Topera lands CE Mark, 510(k) clearance for heart catheter

Topera lands CE Mark, 510(k) clearance for heart catheter and mapping station

Topera said it landed a pair of regulatory wins for its FIRMap catheter.

The Palo Alto, Calif.-based medical device company said it won the CE Mark approval in the European Union and 510(k) clearance from the FDA for the device.

Electrograms captured by the FIRMap catheter are mapped by the already-approved RhythmView 3D mapping workstation, providing electrophysiologists with a “dynamic representation" of the heart’s electrical activity for the treatment of arrhythmias, according to the press release.

“This FDA clearance and the recently received international CE Marks for both FIRMap and RhythmView represent a series of significant milestones for Topera. With this product now commercially available, we are able to offer our panoramic diagnostic catheter with our next-generation 3D mapping system. We believe this will help us expand our leadership in identifying and defining the discrete sources that sustain complex arrhythmias,” CEO Edward Kerslake said in prepared remarks.

Topera reeled in a $25 million Series C round, 1st reported by MassDevice.com, last spring. First-time backer New Enterprise Assoc. led the round, which also included an unnamed "strategic industry partner."

The company, which came out of stealth mode at the annual Heart Rhythm Society meeting last year, originally unveiled the highly anticipated results of its Confirm study at the HRS meeting in Boston in May 2012, touting a 100% success rate. In July, the company released other results from the trial in which researchers said they were able to "shut down atrial fibrillation or very significantly slowed it in 86% of patients in an average of only 2.5 minutes."

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