Medtronic Gets FDA Approval For NuVent
Medtronic plc (NYSE: MDT) revealed the approval of Food and Drug Administration (FDA) for its NuVent, an EM sinus dilation system, for patients with scarred, granulated, or previously surgically-altered tissue - an expansion of indications. According to the company, patients coming in for revision sinus surgery (RSS) have these tissue characteristics.
Medtronic said NuVent was the first and only balloon sinus dilation system with built-in electromagnetic (EM) surgical navigation technology. The company added that it might help surgeons confirm anatomy, as well as maximize placement in balloon sinus surgery. The company stated that RSS might be required when sinus surgery does not lessen suffering, and could pose unique challenges due to possible scar tissue apart from altered anatomy from the earlier surgeries.
Rick Chandra, M.D., professor of otolaryngology, chief of rhinology, sinus & skull base surgery, Vanderbilt University, commented, "NuVent is an ingenious surgical tool that combines automatic calibration, precise electromagnetic navigation, and balloon dilation technology all in one device. It has been extraordinarily useful in accomplishing the goals of revision functional endoscopic sinus surgery, particularly to address technical challenges associated with the frontal sinus."
Medtronic said that when performed in the doctor's office, the procedure was minimally invasive, provides quick recovery times and may enable eligible patients to have a lower out-of-pocket cost.
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