Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that the Heart and Vascular Center Bad Bevensen has performed the first successful cases with the Magellan Robotic System in Germany. These cases were performed by Dr. Thomas Nolte, Director Vascular Center, and Chief of Vascular Surgery and the Wound Center at the hospital.
"We are excited to announce the successful completion of the first peripheral vascular procedures in Germany with the Magellan System by Dr. Nolte at the Heart and Vascular Center Bad Bevensen," said Bruce Barclay, president and CEO of Hansen Medical. "We continue to be very encouraged by the breadth of clinical anatomy in which the Magellan System is currently being used to treat patients with peripheral vascular disease, and are pleased to have another site realizing the real-world benefits of the Magellan System."
"We recently began using the Magellan System at the Heart and Vascular Center Bad Bevensen and have experienced excellent results thus far," commented Dr. Nolte. "Robotic supported navigation could revolutionize the practice of interventional vascular medicine. The Magellan System has the potential to deliver successful patient outcomes in even complex procedures, while allowing for fast and predictable cases and reducing the radiation burden for the surgeon."
"Our hospital has a history of evaluating new technology," said Professor Gerhard Wimmer-Greinecker, MD, Medical Director of the hospital. "We will continue to expand the use of the Magellan System throughout the peripheral vasculature and are excited that we can now offer patients throughout Germany these new minimally-invasive and interventional procedures."
About the Magellan Robotic System
Hansen Medical's Magellan Robotic System is based upon the flexible robotic technology incorporated in the Sensei-X® Robotic Catheter System currently sold in the U.S. and Europe, which has been used in over 10,000 patients, but includes a number of key enhancements. In particular, the Magellan Robotic System:
Provides solid catheter stability for placement of therapeutic devices. Is designed to enable predictable procedure times and increased case throughput. Allows for independent, individual robotic control of the distal tips of both the outer sheath and the inner leader catheter, as well as robotic manipulation of standard guidewires. Is designed to allow for sufficient extension inside the body to access hard to reach peripheral anatomy. Preserves the open architecture featured in the Sensei System to allow for the subsequent use of many 6F therapeutic devices on the market today. Is designed to potentially reduce physician radiation exposure and fatigue by employing a remote physician workstation.
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 and Artisan 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 were 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.