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May 3, 2007
Hansen Medical Receives FDA Approval
Hansen Medical was founded by Fred Moll, founder of Intuitive Surgical and Senior Advisor at Kearny Venture Partners. Hansen represents Fred's fourth successful entrepreneurial venture. Fred and his team have developed a robotically-controlled catheter to perform minimally invasive procedures, beginning with intracardiac ablation for atrial fibrillation. KVP partner Jim Shapiro serves on the board of Hansen. Below, Hansen reports FDA approval of its Sensei and Artisan devices.
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Hansen Medical announced today that it has obtained U.S.
Food & Drug Administration (FDA) clearance for commercialization
of the Sensei(TM) Robotic Catheter System and Artisan(TM)
Control Catheter to facilitate manipulation, positioning
and control of mapping catheters during electrophysiology
(EP) procedures.
The clearance allows physicians to use Hansen Medical's
first generation robotic platform to easily place mapping
catheters in hard-to-reach anatomical locations within
the heart and maintain catheter stability during the diagnostic
phase of complex cardiac arrhythmia treatment. Physicians
who have used this product for EP procedures say the Sensei
system has the potential to change the way cardiac procedures
are performed to a more standard approach for complex
diseases.
Andrea Natale, M.D., director for the Center for Atrial
Fibrillation, director of the Electrophysiology Laboratories
and head of the Section of Pacing and Electrophysiology
at the Cleveland Clinic Foundation, used the Sensei system
during clinical evaluation on 25 patients in the Czech
Republic and Germany. "The stability of the Artisan
catheter allowed us to perform catheter mapping procedures
more efficiently and effectively," said Dr. Natale.
"Moreover, the incorporation of the new Sensei system
and catheter did not add time to the procedures, nor did
it require increased radiation time, as would normally
be expected with new technology. As a result, I would
expect this new system to become the medical standard
for performing complex EP procedures, which are currently
limited to those individuals with the highest level of
skill."
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