HMM: US FDA staff raise no concerns about Otsuka, Medtronic blood pressure devices. “The surgery, known as renal denervation, is allowed in Europe and other parts of the world, but is not yet approved in the U.S., after initial studies of older devices used in the procedure failed key trials. The staff reviewers said the available safety data for the device made by ReCor, a unit of Otsuka Holdings, did not raise concerns, while pointing that there was limited long-term data. There was no specific comment on Medtronic’s device. ReCor’s device, a balloon-like structure inside a catheter, is inserted through a small cut into the kidney’s arteries and sends ultrasound energy to burn nerves that are believed to control blood pressure. On the other hand, Medtronic’s device is a spiral shaped catheter and generator combination that uses targeted radiofrequency energy to destroy select nerves.”