No concerns about Medtronic, Otsuka BP devices raised by USFDA staff
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.;
The U.S. Food and Drug Administration (FDA) staff reviewers said on Friday they found no safety and effectiveness issues with devices made by Otsuka Holdings and rival Medtronic Plc for use in a blood pressure treatment surgery.
The FDA staff's assessment comes ahead of meetings of two independent expert panels next week, where they will make recommendations on whether or not to approve the devices for treatment.
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.
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