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.
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.
Mountain View, Calif.-based Hansen recently announced a collaboration with Philips Healthcare (NYSE:PHG), teaming up to integrate Hansen’s Magellan robot with Phillips’ Allure X-ray system.