Northeastern Law Faculty Affiliated with the Amy J. Reed Collaborative Petition FDA Over Off-Label Use of Robotic and VATS Devices for Treatment of Persistent Atrial Fibrillation in Elderly Patients

05.06.25—Northeastern Law professors  David A. Simon and Hooman Noorchashm together with Dr. Michael Paasche-Orlow of Tufts Medical Center, who serve as co-directors of the Amy J. Reed Collaborative for Medical Device Safety (AJRC), have submitted a Citizen Petition to the FDA requesting that the agency scrutinize the off-label use of the Da Vinci Robotic System or VATS systems in “Hybrid Convergent Ablation” - an increasingly widespread clinical treatment approach for isolated persistent atrial fibrillation in elderly Americans. The procedure is frequently reimbursed by Medicare — and the Petition’s goal is to ensure that these human subject investigational treatments are not being unknowingly reimbursed by the Centers for Medicare and Medicaid Services (CMS).

“Investigational uses of medical devices in 'significant risk' clinical areas, like ablation of atrial fibrillation, require oversight by both local IRBs and the FDA,” said Noorchashm, an internationally recognized medical device safety expert “especially if/when such investigational treatments are reimbursed by CMS.”