Endosense eyes FDA nod with ablation trial
|Endosense has treated its first U.S. patient in a trial of the TactiCath Quartz--courtesy of Endosense|
Fresh off raising $40.3 million in venture cash, Endosense has treated its first American patient in a study of its cardiac catheter ablation device, and the company is amassing data to support an FDA application.
The TactiCath Quartz treats cardiac arrhythmias and is the first device of its kind to allow physicians measure in real time the amount of contact force used during catheter ablation, Endosense says. The device got its CE mark in June, and the Swiss devicemaker commercialized it in Europe last month.
The current study supplements existing data showing the Quartz model is safe and effective, and Endosense expects file for a PMA in the fourth quarter of this year.
"The TactiCath Quartz brings several technical and functional advancements to the electrophysiology lab that further strengthen our leadership position in the field," Endosense CEO Jan Keltjens said in a statement. "(This study) will pave the way for us to continue to offer electrophysiologists and their patients the most advanced contact-force sensing technology available, once we achieve anticipated approval in the United States."
Endosense is hardly alone in the space: Johnson & Johnson ($JNJ) and St. Jude Medical ($STJ) have catheter ablation devices on the market, and Boston Scientific ($BSX) spent $90 million on Rhythmia Medical last year to break into the field. But Endosense has the only product with real-time contact force sensors built in, and the company believes that will set it apart from its competitors.
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