Topera, developer of a 3-D device and mapping tool designed to detect cardiac rhythm problems, is ramping up commercial sales of its debut technology in the U.S. and Europe now that crucial regulatory sign-offs are in place.
The Palo Alto, CA, company and 2013 Fierce 15 winner already had 510(k) clearance for its RhythmView workstation, but now it has obtained a similar nod for its FIRMap catheter that goes with it. Topera also recently gained CE marks for both devices.
CEO Edward Kerslake told FierceMedicalDevices via email that the company has begun marketing efforts in Europe. In the U.S., RhythmView sales are already underway, but now Topera is moving to supply the catheters so doctors can begin to actively use the technology.
RhythmView is loaded with processing software, and the FIRMap catheter, which is expanded into the atrium, is built with dozens of electrodes. The diagnostic tool makes contact with the atrium walls, where it captures signals processed to create detailed images of the electrical flows in the heart. In short, the system is meant to detect the source of heart rhythm disorders such as atrial fibrillation, atrial flutter and atrial and ventricular tachycardia. Right now, the standard of care is much less thorough, relying, in part, on a series of tests that provide a more limited picture, the company has said, noting that physicians must sometimes guess which part of the atrium needs therapy.
Topera's technology has major backing. Founded in 2010, the company secured a $25 million Series C financing earlier in 2013 backed by the likes of New Enterprise Associates, plus an as-yet-unnamed "strategic industry partner."
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Special Report: 2013 Fierce 15 - Topera Medical