ISSUE: FDA is alerting the public about an experimental procedure called Transvascular Autonomic Modulation (TVAM). This procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials. The procedure uses balloon angioplasty devices outside the scope of the FDA-approved indications for use. If the FDA and federal prosecutors only knew what really went on behind the scenes, their heads would explode. Welcome to the medical device world!
I wonder if FDA knows that docs at a certain hospital in Pittsburgh use a Neuron Max sheath to open up carotid stenosis during treatment for stroke.
I wonder if the FDA knows that every day, around the country, physicians exercise independent judgement while practicing medicine.
Independent judgment is a myth. Follow the money trail and get rid of all financial conflicts of interest, snake oil sales, and marketing ploys. Then independent judgment will be what the term suggests. Just look at Medicare Open Payments and put it all together.
