Hansen Medical, Inc., a global leader in intravascular robotics, and Adachi Co., Ltd. today announced a distribution agreement for Magellan™ and Sensei® Robotic Systems in Japan. As part of the distribution agreement, Adachi is responsible for obtaining Japanese Marketing approval from the Pharmaceuticals and Medical Devices Agency for the Magellan and Sensei Robotic Systems.
"We are delighted to enter into this comprehensive distribution partnership with Adachi," said Cary Vance, Hansen Medical President and CEO. "Adachi has proven to be exceptionally adept at selling robotic systems in Japan and it has a long history of success with cutting-edge technology."
Hansen Medical's Intravascular Robotic technologies are designed to deliver accurate robotic catheter control and stability during a wide variety of endovascular and electrophysiology (EP) procedures. Both the Magellan and Sensei Robotic Systems provide for accurate navigation capabilities while allowing the physician to be seated comfortably away from the radiation in a centralized, remote workstation.
"Japanese physicians and hospitals have embraced robotic technologies to improve patient care and healthcare economics," said Mr. Saburo Adachi, President and CEO of Adachi Co., Ltd. "Endovascular and electrophysiology procedures are rapidly increasing in Japan. The Magellan and Sensei Robotics Systems represent a great opportunity to help a large and growing Japanese patient population receive the benefits of intravascular robotic therapies and we are excited to lead this effort in Japan."
About Hansen Medical, Inc.
Hansen Medical, Inc., based in Mountain View, California, is a 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, 9Fr Magellan™ Robotic Catheter, Magellan™ 6Fr Robotic Catheter, and related accessories are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The Magellan 9Fr Robotic Catheter has undergone both CE marking and 510(k) clearance and is commercially available in the European Union, and the U.S. The Magellan 6Fr Robotic Catheter has undergone 510(k) clearance in the U.S. and is in limited release for the next several months in anticipation of more wide-scale commercially availability later in 2014. In the European Union, the Company's Sensei® X Robotic Catheter System and Artisan® and Artisan Extend® Control Catheters 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 and Artisan Extend Control Catheters are cleared by the U.S. Food and Drug Administration for manipulation and control of certain mapping catheters in EP procedures. In the U.S., the Sensei X Robotic Catheter 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 Robotic Catheter System and Artisan and Artisan Extend 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.
Source: http://www.hansenmedical.com/