Hansen Medical Inc. (HNSN) announced it has received conditional approval from the U.S. FDA to change the study design of its ARTISAN-AF Trial, a pivotal clinical trial evaluating the use of its Artisan family of Control Catheters with its Sensei X Robotic Catheter System for treatment of Atrial Fibrillation, or AF, the most common cardiac arrhythmia.
The ARTISAN- AF Study was unconditionally approved under an investigational device exemption by the FDA in October 2010 and was originally designed to enroll 300 patients at 14 leading hospitals, as a prospective, randomized study. Under the revised protocol, the study will be a single arm, target performance goal study enrolling as few as 100 subjects at up to 14 investigational sites.
The study will track two primary endpoints: Safety, defined as the incidence of early onset major adverse events and major complications through six months, and efficacy, defined as freedom from AF through one year. Additionally, data will be collected to measure radiation exposure and single-procedure success rates.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.