Hansen Medical has enrolled first patients for ARTISAN-AF clinical trial to evaluate the use of Artisan family of control catheters with its Sensei X robotic catheter system for treatment of atrial fibrillation.
The robotic catheter system is a next generation minimally-invasive, which combines advanced levels of 3D catheter control and 3D visualization.
It is powered by an accurate, robotically controlled arm that allows catheter navigation, stability and positioning within the patient’s heart atria.
In May, the company received conditional approval from the US Food and Drug Administration (FDA) for this new study design.
Under the revised protocol, the study will be a single arm, target performance goal study, enrolling as few as 125 subjects at up to 14 investigational sites.
Hansen Medical president and CEO Bruce Barclay noted the enrollment of patients into this study is an important milestone for the company.
"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.
"The achievement of a broader label claim has the potential to drive further growth of our U.S. EP business," Barclay added.
This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data.