On 5 August, Hansen Medical announced that the first patients have been successfully enrolled in the new study design of its ARTISAN-AF study, a pivotal clinical trial evaluating the use of Hansen Medical’s Artisan family of control catheters with its Sensei X Robotic Catheter System for treatment of atrial fibrillation.
In May, the company announced that it received FDA conditional approval of the new study design. Under the revised protocol, the study will be a single arm, target performance goal study enrolling as few as 125 subjects at up to 14 investigational sites. The principal investigator of the full trial is Andrea Natale, executive director for Texas Cardiac Arrhythmia Institute. The co-principal investigator is Joseph Gallinghouse, electrophysiologist, at the Texas Cardiac Arrhythmia Research Foundation and his team.
“I am pleased to be the first physician to enrol a patient into this new study,” said Gallinghouse. “The new study design recently agreed upon with the FDA will greatly facilitate enrolment in the trial, and allow us to evaluate clinical endpoints in an expedited fashion. I look forward to continuing to enrol patients into and completing this critical evaluation of ablation of atrial fibrillation using robotic navigation.”
“The enrolment of patients into this study is an important milestone for Hansen Medical,” said Bruce Barclay, Hansen Medical president and chief executive officer. “If successful, we intend to use the data derived from this study to support a submission to the FDA to obtain approval for a broader label claim for use of our Artisan family of Control Catheters with our Sensei X Robotic Catheter System in atrial fibrillation procedures. The achievement of a broader label claim has the potential to drive further growth of our US EP business.”