Hansen Medical, Inc., a global leader in intravascular robotics, today announced that the first patients have been successfully enrolled in the new study design of its ARTISAN-AF Trial, a pivotal clinical trial evaluating the use of Hansen Medical's Artisan® family of Control Catheters with its Sensei® X Robotic Catheter System for treatment of Atrial Fibrillation (AF), the most common cardiac arrhythmia.
In May, the Company announced that it had received conditional approval of the new study design from the U.S. Food and Drug Administration (FDA).
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. The principal investigator of the full trial is Andrea Natale, M.D., F.A.C.C., F.H.R.S., executive director for Texas Cardiac Arrhythmia Institute. The co-principal investigator is Joseph Gallinghouse, M.D., electrophysiologist, at the Texas Cardiac Arrhythmia Research Foundation (TCARF) and his team. Dr. Gallinghouse was the first physician to enroll a patient into the study under the revised protocol following IRB approval.
"I am pleased to be the first physician to enroll a patient into this new study," said Dr. Gallinghouse. "The new study design recently agreed upon with the FDA will greatly facilitate enrollment in the trial, and allow us to evaluate clinical endpoints in an expedited fashion. I look forward to continuing to enroll patients into and completing this critical evaluation of ablation of atrial fibrillation using robotic navigation."
"The enrollment of patients into this study is an important milestone for Hansen Medical," said Hansen Medical President and CEO, Bruce Barclay. "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."
Atrial Fibrillation is the most common cardiac arrhythmia, and it affects an estimated 3.3 million Americans and 4.5 million Europeans. This number is expected to increase due to an aging population and a rising number of people with chronic heart disease. AF is associated with increased long-term risk for severe and disabling stroke.
About Sensei® X Robotic Catheter System
Through continued advancement of medical robotics, Hansen Medical has developed a next generation minimally-invasive, robotic catheter system, the Sensei X Robotic Catheter System, which combines advanced levels of 3D catheter control and 3D visualization. This unique, state of the art technology has been used in over 10,000 patients, and is powered by an accurate, robotically controlled arm that allows for catheter navigation, stability and positioning within the patient's heart atria, allowing for the following system advantages:
- Catheter Stability with Force-Sensing
- Instinctive 3D Control
- Potential for Reduced Fluoro Time for Physician
Source: http://www.hansenmedical.com/