Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to change the 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.
Under the revised protocol, the study will be a single arm, target performance goal study enrolling as few as 100 subjects at up to 14 investigational sites. The study will track two primary endpoints: Safety, defined as the incidence of early onset major adverse events and major complications through six months, and efficacy, defined as freedom from AF through one year. Additionally, data will be collected to measure radiation exposure and single-procedure success rates. The study will evaluate the use of the Sensei X System with the family of Artisan® Control Catheters for introducing and positioning the Biosense Webster NAVISTAR® THERMOCOOL® Catheter in patients with paroxysmal AF. While the approval of the revised protocol is conditional, it permits immediate enrollment of new patients at the Company's existing study sites, subject to site IRB approval. The Company intends to further modify the investigational plan to clarify data analysis information, but does not expect that these modifications will affect patient enrollment or data collection under the revised protocol.
The ARTISAN- AF Study was unconditionally approved under an investigational device exemption (IDE) by the FDA in October 2010 and was originally designed to enroll 300 patients at 14 leading hospitals, as a prospective, randomized study.
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.
"We are excited about the opportunity to continue testing Robotic Navigation with the Hansen System", said Dr. Natale.
"I am very pleased that the FDA has approved the new protocol design submitted by Hansen Medical", said Dr. Gallinghouse. "This will greatly facilitate enrollment in the trial, and allow us to evaluate clinical endpoints in an expedited fashion. I look forward to the continuation of this critical study of ablation of atrial fibrillation using robotic navigation."
"This study is an important step toward expanding our United States labeling to include use of our Artisan family of control catheters with our Sensei X Robotic System to navigate certain ablation catheters, and we believe this will be a positive factor in the growth of our US EP business given our expectation that the ARTISAN- AF study will enroll patients much more quickly than the previous study design," said Hansen Medical President and CEO Bruce Barclay. "We are encouraged and gratified by the prestigious medical centers and physicians that are or have expressed interest in participating in the trial, and we believe that the study results will demonstrate important benefits of our technology for both patients and the physicians who treat them."
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
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is the global leader in intravascular robotics, developing products and technology designed to enable the accurate positioning, manipulation and control of catheters and catheter-based technologies. The Company's Magellan Robotic System, Magellan Robotic Catheter and related accessories, which are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, have undergone both CE marking and 510(k) clearance and are commercially available in the European Union, and the U.S. In the European Union, the Company's Sensei® X Robotic Catheter System, Artisan Control Catheter and Artisan Extend® Control Catheter are cleared for use during electrophysiology (EP) procedures, such as guiding catheters in the treatment of atrial fibrillation (AF), and the Lynx® Robotic Ablation Catheter is cleared for the treatment of AF. This robotic catheter system is compatible with fluoroscopy, ultrasound, 3D surface map and patient electrocardiogram data. In the U.S. the Company's Sensei X Robotic Catheter System and Artisan Control Catheter are cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in EP procedures. In the United States, the Sensei System is not approved for use in guiding ablation procedures; this use remains experimental. The U.S. product labeling therefore provides that the safety and effectiveness of the Sensei X System and Artisan Control Catheter for use with cardiac ablation catheters in the treatment of cardiac arrhythmias, including AF, have not been established. Additional information can be found at www.hansenmedical.com.