Medtronic Gets FDA Nod for Renal Denervation Trial
We last reported on Ardian’s Symplify system of renal denervation for treatment-resistant hypertension in Nov. 2010
Since then, Ardian has been acquired by Medtronic, and the FDA has just approved a U.S. trial of the catheter-based hypertension treatment. In case you missed it last year, the Symplicity system consists of a catheter that is passed through the femoral artery into the renal artery, where a generator delivers radio-frequency signals to modulate the sympathetic nerves that reside there.
The data up to this point appear promising, with a trial from Europe, Australia and New Zealand showing a mean blood pressure reduction of 32/12 mm Hg at 6 months.
George Bakris, M.D., professor of medicine and director of the Hypertension Center at the University of Chicago Medical Center says the following :
“The imminent start of this clinical trial marks a pivotal point in the study of hypertension treatments. HTN-3 will assess the efficacy and safety of renal denervation with the Symplicity Catheter System – a treatment approach that represents a first in our field: a catheter-based intervention for patients with resistant hypertension who have been unable to achieve target blood pressure levels despite multiple medications.”
More info on the trial is available here…
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