Clinical Experience
Through March 2011, physicians have performed a cumulative total of more than 5,000 clinical cases using Hansen Medical’s Sensei system. Recent data from independent clinical studies has been encouraging. For example, a group of physicians associated with the Texas Cardiac Arrhythmia Institute published a study of 390 patients comparing success rates in those having catheter ablation of atrial fibrillation performed robotically to those performed manually over the same period in a single institution. The cohort was mixed and included patients with paroxysmal and persistent AF. Surgeons were able to isolate all pulmonary veins in 100% of patients in both groups. There was no difference in procedure time between manual and robotic ablation, although there was a reduction in fluoroscopy time (X-ray use) with robotic ablation. Success rates were: 85% with robotic ablation versus 81% if performed manually at 14 months. Additional clinical case studies from a U.S. community hospital was recently published in Cardiovascular Business showing the economic value possible with the Sensei System.
In May 2010, the company announced that it received conditional Investigational Device Exemption (IDE) approval from the U.S. FDA authorizing a clinical trial to investigate use of the Sensei X Robotic Catheter System and the Artisan Control Catheter for treatment of AF. The first case in the ARTISAN AF Trial, a clinical trial using the Sensei X system for the treatment of AF, was completed May 11, 2010 by Joseph Gallinghouse, M.D., electrophysiologist, at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center. The Principal Investigator of the trial is Andrea Natale, M.D., F.A.C.C., F.H.R.S., executive medical director for TCAI.
In September 2010, Hansen announced the first commercial sale of its Lynx Irrigated Ablation Catheter, a smaller robotic catheter with a flexible integrated ablation catheter designed to improve the treatment of cardiac arrhythmias. The rollout of the Lynx catheter in Europe marked an expansion from its core robotic navigation technology to include proprietary therapy delivery devices. In October 2010, Hansen announced the completion of the First in Man Study for the Company’s vascular robotic system, during which 20 peripheral endovascular procedures were successfully performed at a European clinical site. Hansen filed for 510(k) clearance to market the vascular robot system in the U.S. in April 2011 and expects the device to begin selling commercially in second half of 2011.
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