Sensei Robotic Catheter System

Sensei Robotic Catheter System

The Sensei X robotic catheter is a medical robot designed to enhance a physician’s ability to perform complex operations using a small flexible tube called a catheter. As open surgical procedures that require large incisions have given way to minimally invasive surgeries in which the surgeon gains access to the target organs through small incisions using specialized surgical tools. One important tool used in many of these procedures is a catheter used to deliver many of things a surgeon needs to do his work, to impact target tissue and deliver a variety of medicines or disinfecting agents to treat disease or infection.

Manufactured by Hansen Medical, Sensei X is a specialized robotic catheter system that is controlled by a physician and is designed for accurate positioning, manipulation and stable control of catheter and catheter-based technologies during cardiovascular procedures. The Sensei system obtained U.S. Food and Drug Administration (FDA) clearance in 2007, after which the Cleveland Clinic's electrophysiology program, then directed by Dr. Andrea Natale, received the first placement. The Sensei Robotic Catheter System and Artisan Control Catheter allow physicians to navigate flexible catheters with greater stability and control during complex cardiac arrhythmia procedures. Hansen Medical has related co-development agreements with the following industry leaders: St. Jude Medical, GE Healthcare, Siemens Healthcare, and Philips Medical Systems.

Hansen Medical was founded by Dr. Frederic Moll, who had also co-founded Intuitive Surgical, manufacturer of the Da Vinci Surgical System, whose use has propelled medicinal robotics to the forefront of patient care. The Sensei system is indicated for use during the cardiac mapping phase of cardiac arrhythmia treatment in the US. Meanwhile, it has CE mark approval for facilitating the navigation of ablation catheters within the atria of the heart during complex arrhythmia procedures such as Atrial Fibrillation (AF).

In November 2010, Hansen Medical received unconditional Investigational Device Exemption (IDE) approval from the FDA initiating a clinical trial to investigate the use of the Sensei X Robotic Catheter System and the Artisan Control Catheter for treatment of AF, the most common cardiac arrhythmia. The Principal Investigator of the ARTISAN AF Trial is Dr. Andrea Natale, executive medical director for Texas Cardiac Arrhythmia Institute (TCAI). The first case in the trial was completed by Dr. Joseph Gallinghouse, an electrophysiologist, at the TCAI at St. David's Medical Center.

By the end of 2010, nearly 100 Sensei systems have been shipped worldwide since its 2007 release. The system has been used to perform almost 5,000 procedures. The Sensei system operates by guiding standard catheters through a manipulated robotically steerable sheath (hollow tube) in the patient's vasculature. The doctor performs the procedure at a control station with a technology called "IntelliSense" to proximally measure the forces applied along the shaft of the catheter as a result of catheter tissue contact. The Artisan catheter has two robotically controlled segments which provides six degrees of freedom and 270 degrees of bend articulation which can assist physicians in accessing hard-to-reach cardiac anatomy. The open lumen Artisan catheter accommodates 8F percutaneous EP catheters. Centers have reported acute and long term success rates consistent with manual procedures.