Hansen Medical (NSDQ:HNSN) said the FDA approved its plan to expand a study testing its Sensei robot-assisted surgery device to include devices made by St. Jude Medical (NYSE:STJ) and Johnson & Johnson (NYSE:JNJ) BioSense Webster division.
The study, Artisan-AF, is examining the Sensei robot in treating atrial fibrillation. The FDA nod means investigators in the trial can use St. Jude’s EnSite Velocity cardiac mapping system and BioSense Webster’s Thermocool SmartTouch ablation catheter.
Afib is the most common form of heart arrhythmia, affecting nearly 3 million Americans. The condition can be treated through a procedure called radiofrequency catheter ablation, which helps blocks erratic electrical impulses in the heart.
“There is a substantial amount of innovation in the treatment of atrial fibrillation for catheter ablation, including distal tip contact force sensing catheters like SmartTouch,” principal investigator Dr. Joe Gallinghouse said in prepared remarks. “Early studies have indicated that the combination of SmartTouch and Sensei robotic navigation could provide improved outcomes for patients.”
Last month, Hansen announced that its Magellan robotic system was used to perform the world’s 1st robot-assisted retrieval of an inferior vena cava filter.