Medtronic Announces First Patient Treated in TERMINATE AF Clinical Trial

Medtronic (NYSE:MDT) today announced the first patient treated in the TERMINATE AF trial, a multi-center study evaluating two surgical ablation devices – the Cardioblate(TM) Irrigated RF (IRF) System and the CryoFlex(TM) Surgical Ablation System – for the treatment of non-paroxysmal (persistent or longstanding persistent) atrial fibrillation (AF) in patients undergoing open-heart surgical procedures.

As quoted in the press release:

Following investigational device exemption (IDE) approval by the U.S. Food and Drug Administration (FDA), the first patient was treated in the study by the heart team led by Ralph Damiano, M.D., at Washington University School of Medicine in St. Louis. In the U.S., use for treatment of AF is investigational use only.

During the surgical ablation procedure, surgeons will use the two ablation devices – deploying both “heat” (Cardioblate Irrigated Radio Frequency ablation) and “cold” (CryoFlex cryoablation) as needed – to make a pattern of lesions in the heart muscle, which are intended to help the heart to return to its normal rhythm. The investigational procedure will be conducted to evaluate the treatment of atrial fibrillation in patients during other surgical heart procedures, such as bypass surgery, heart valve repair or replacement.

“The Terminate AF trial provides a unique opportunity to study the combined use of two surgical ablation technologies to treat surgical patients who suffer from AF,” said Ralph J. Damiano, M.D., chief of the Division of Cardiothoracic Surgery at Washington University School of Medicine and Barnes Jewish Hospital, and national principal investigator of the Terminate AF trial. “We anticipate the trial will help us uncover important procedural insights and potentially help surgeons and heart teams treat more patients with this widespread disease.”

Click here to read the full press release.