Robotic technology developer Hansen Medical of Mountain View, CA, has completed a seven-day clinical trial of its Sensei robotic catheter system.
The 20-patient prospective trial was an observational study using the Sensei system to guide catheters into the heart for mapping heart anatomy. The company believes that heart mapping is a critical step in identifying heart tissue that generates abnormal heart rhythm and that might require treatment.
Data from the trial showed no adverse device-related events, and is being prepared as part of a submission to the U.S. Food and Drug Administration in support of a 510(k) application that is currently being reviewed.
The Sensei system guides catheters using fluoroscopic, intracardiac ultrasound, 3D surface maps, and patient electrocardiogram data, according to the company.
By AuntMinnie.com staff writers
December 25, 2006
Related Reading
Hansen to go public, November 16, 2006
Hansen unveils new robotic catheter system, May 17, 2006
Hansen raises $30 million, November 18, 2005
Intuitive Surgical forms pact with Hansen, September 15, 2005
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