Hansen Medical Announces FDA Conditional IDE Approval for Evaluating Sensei X Robotic Catheter System for Treatment of AF
Hansen Medical, Inc. announced that it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food & Drug Administration (FDA) authorizing a clinical trial to investigate use of the Sensei® X Robotic Catheter System and the ArtisanTM Control Catheter for treatment of atrial fibrillation (AF).The first case in the ARTISAN AF Trial, a pivotal clinical trial using the Sensei X system for the treatment of AF, was completed May 11, 2010 by Joseph Gallinghouse, MD from the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center. The Principal Investigator of the trial is Andrea Natale, MD, executive medical director for TCAI.
"As an early adopter of the Sensei technology, and an experienced electrophysiologist, I am very pleased to initiate this important study to advance the clinical understanding of this groundbreaking flexible robotic technology in the treatment of arrhythmias," said Dr. Natale.
The ARTISAN AF Trial is a prospective, randomized study of the Hansen Medical Sensei X System for introducing and positioning the Biosense Webster NAVISTAR® THERMOCOOL® Catheter in patients with AF.The trial will enroll patients with symptomatic, drug-refractory paroxysmal AF at a 2:1 ratio and evaluate robotic technique versus manual technique for the ablation of AF. There are two primary endpoints: safety, defined as the absence of early onset of all major adverse events, and efficacy, defined as freedom from AF through one year. Up to 14 investigative sites worldwide will enroll 300 subjects. The trial protocol recommends that the IntelliSense® force sensing system be used to guide ablative lesion placement. The IntelliSense readings of 10-20g during ablation, with a maximum of 40g are recommended. The protocol also recommends that ablation is performed using irrigated RF power settings of 20-25W with a maximum power of 30W, and a maximum temperature of 50o C. Additionally, data will be collected to compare the reduction in radiation exposure and the potential improvements in single-procedure success rates.
"We are enthusiastic about working closely with the FDA in executing this critical study," said Dan Wallace, co-founder and vice president of regulatory, clinical and advanced applications for Hansen Medical.
In order for physicians to participate in the ARTISAN AF Trial, he or she must have previously performed at least 20 procedures with the Sensei system. In addition, they must enroll at least two patients per month as a study investigator, and they need to have performed a minimum of 100 AF ablation procedures manually.
"My colleagues and I have completed more than 385 cases using the Sensei system and we are thrilled to be taking part in this timely and important study," said Dr. Gallinghouse. "In addition to evaluating safety and efficacy, this study design provides us an opportunity to investigate whether less radiation and RF energy is used robotically, compared to what may be typical with manual technique."