Topera Medical picked up FDA clearance for the latest generation of its 3-D Mapping System, a device designed to help diagnose cardiac arrhythmias without invasive surgery.
The system includes Topera's already-cleared FIRMap catheter and RhythmView workstation, and the trio of regulatory nods allows the 2013 Fierce 15 winner to jump-start the marketing of its technology in the growing market for electrophysiology devices. Topera's system, first introduced in 2011, is meant to map out the cardiac anatomy in order to detect the source of heart rhythm disorders such as atrial fibrillation, atrial flutter and atrial and ventricular tachycardia.
The latest generation of the technology works near instantaneously, the company said, providing a level of detail unrivaled by standard-of-care mapping tools and helping guide precision treatments. The system's promise was a major factor in Topera's recent $25 million financing round, led by venture giant New Enterprise Associates.
Meanwhile, electrophysiology remains a fast-growing, in-demand space, as device giants like St. Jude Medical ($STJ) and Boston Scientific ($BSX) have spent millions over the past year to get their hands on new technologies in the field. And while Topera is likely to get its share of takeover pitches, CEO Edward Kerslake said in October that the company has no plans to take a buyout, preferring to preside over the launch of its technology.
"I can't build a company based on somebody else's choices," Kerslake said. "We are in love with the technology and are all enjoying the company and see no reason to look for an exit at this time."
- read the announcement
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