UPDATE: Hansen Medical Offers Update on Key Near-Term Clinical, Regulatory, Commercial Events

Hansen Medical, Inc. HNSN, the global leader in intravascular robotics, today provided an update of key corporate initiatives which, if successful, will expand the utility and regulatory labeling of the Sensei® and Magellan™ product lines: ARTISAN IDE Study: This study is a prospective, single arm study of the Hansen Sensei System for introducing and positioning RF ablation catheters in subjects with paroxysmal atrial fibrillation (PAF). As of January 8, 2016: 148 subjects have been enrolled and treated, and 2 cases are pending to complete full enrollment of 150. In preparation for future commercialization, the initial PMA shell was submitted to FDA, paving the regulatory pathway. This clinical trial includes a Bayesian adaptive design, which permits an interim analysis and incorporates stopping rules to evaluate early success or futility. "The upcoming interim analysis of the ARTISAN study has been long-awaited by physicians and patients, and we look forward to sharing the results promptly and hope it will be informative about the role of robotics in the treatment of PAF," said Cary Vance, President and CEO of Hansen Medical. Additional key details for the ARTISAN IDE Study are described below; the ClinicalTrials.gov Identifier for this trial is NCT01122173: Primary Safety Endpoint: The incidence of Major Complications, including the early onset (within 7 days of the ablation procedure) predefined complications; and the incidence of esophageal injury or pulmonary vein stenosis through day 180. Hypothesis: The study is designed to determine if the Major Complication rate meets the pre-established target performance goal (TPG) of 16%. Primary Key Effectiveness Endpoint: Chronic Success: Freedom from symptomatic atrial fibrillation, atrial flutter, and atrial tachycardia episodes from days 91-365 after the initial ablation procedure, as documented by event recording, ECGs and Holter monitoring. Hypothesis: The study is designed to determine if the effectiveness rate meets the pre-established target performance goal (TPG) of 54%. Indication Expansion Plans: Hansen Medical has begun the preparatory process to submit the 510k to FDA for a neurological indication for the Magellan Robotic System. The company anticipates submitting a 510k to the FDA in Q1 2016 for this expanded indication. "The capabilities of our robotic catheters are opening up new opportunities for physicians", said Francis McNamara, VP, Research and Development at Hansen Medical, "As we expand our suite of advanced micro catheters, we believe there are many opportunities to improve patient outcomes." Commercial Activities: Hansen Medical shipped 4 robotic systems and 1 Mobility Package in Q4, 2015, including units to 2 U.S. Hospitals, a system in partnership with Medtronic to Maastricht University Medical Center in The Netherlands, and systems to AB Medica in Italy and to AFYA Medical Group in Saudi Arabia.