Surgeons make history, perform world’s first living mitral valve replacement

Douglas Overbey, MD, an assistant professor in the department of surgery at Duke University School of Medicine, checks in with 9-year-old Kensley Frizzell as she recovers from heart surgery. Image courtesy of Duke Health and Duke University School of Medicine.

Douglas Overbey, MD, an assistant professor in the department of surgery at Duke University School of Medicine, checks in with 9-year-old Kensley Frizzell as she recovers from heart surgery. Image courtesy of Duke Health and Duke University School of Medicine.

The historic heart procedure was part of a series of operations that saved the lives of three young girls. “The whole situation is extraordinary, whether you look at it from the standpoint of a scientific breakthrough or the average person’s point of view,” one parent said. 

Medtronic enrolls first patient in new coronary DCB trial—data could lead to FDA approval

Prevail DCB Medtronic. Medtronic’s Prevail drug-coated balloon (DCB) has received CE mark approval for several new indications related to the treatment of coronary artery disease (CAD). The paclitaxel-coated device, designed to inflate within the patient’s artery during percutaneous coronary intervention (PCI) procedures, is now approved across the EU to treat CAD patients with multivessel disease, acute coronary syndrome and diabetes.

Prevail DCB graphic courtesy of Medtronic. 

The paclitaxel-coated device, already approved in Europe and other parts of the world, will be tested on more than 1,200 patients for a new international trial. If the study is a success, Medtronic hopes to gain regulatory approval in the United States and Japan.