Robot-assisted surgery: Hansen re-designs Artisan heart surgery study

August 27, 2013 by Sony Salzman

Hansen Medical launches its re-designed Artisan study, enrolling the initial 5 patients to evaluate robot-assisted catheter surgery for atrial fibrillation.

Hansen re-designs Artisan study

Hansen Medical (NSDQ:HNSN) enrolled the 1st 5 patients in a re-designed study to evaluate its robot-assisted atrial fibrillation treatment.

The revised study design, which won conditional FDA approval in May, will eventually enroll 125 patients at 14 medical centers to test Hansen's Sensei X robotic catheter system with the company's Artisan control catheters.

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The Sensei X robot, designed to control catheter movements, has been used in more than 10,000 patients already, according to Hansen. Surgeons control a robotic arm to place a catheter in the patient's heart atria, guided by a 3D navigation system.

"If successful, we intend to use the data derived from this study to support a submission to the FDA to obtain approval for a broader label claim for use of our Artisan family of control catheters with our Sensei X robotic catheter system in atrial fibrillation procedures," CEO Bruce Barclay said in prepared remarks.