CE marking and FDA approval for heart catheter “significant milestones” for Topera Medical

November 11, 2013 | By Anabela Farrica

Topera Medical

Topera’s FIRMap catheter

Topera, the California-based, venture-backed medical device company, landed a pair of regulatory wins for its FIRMap catheter. Besides the 510(k) clearance from the FDA, the device was approved for CE marking in the European Union.

The FIRMap catheter is designed to obtain electrocardiograms in combination with the already approved RythmView 3D mapping workstation. While the contact-mapping basket catheter provides with the electrocardiographic information, the RythmView Workstating offers physicians a dynamic representation of the electrical activity of the heart. With this tool, the electrophysiologist can obtain very specific information about the cause for the complex cardiac arrhythmias of certain patients. These data can be then used to identify the most appropriate therapy to ensure the best possible patient outcome. Right now, the standard of care is much less thorough, making physicians sometimes guess which part of the heart needs to be treated.

The catheter iselft is comprised of an expandable “basket”, a three-dimensional structure (unlike most linear catheters) that conforms to the shape of a full heart chamber.  It contains 64 evenly-spaced electrodes distributed between eight splines, with each spline having eight electrodes.

“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.” , said Edward Kerslake, Topera’s CEO.




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