• FDA panel discusses study design, indications for renal denervation as hypertension treatment

    5 monthes ago - By Healio

    An FDA advisory committee panel discussed several topics regarding the clinical evaluation of device-based therapies, including renal denervation for patients with hypertension.
    Industry and FDA members presented information during the meeting on the premarket clinical trial design, postapproval study design, indications and labeling for device-based treatments for patients with hypertension.
    Besides indications and labeling, questions for the FDA included clinical study design, safety endpoints, effectiveness endpoints and the benefit-risk profile.
    The FDA said it recognizes the importance of
    Read more ...