SYMPLICITY-3 was Medtronic’s play to get into the hypertension business. They have a device that allows physicians to apply burn the sympathetic nerves of the renal arteries and lower the blood pressure. In a previous randomized trial it worked and SYMPLICITY-3 was what they were going to take to the FDA to get approval.
I started the day with our local hypertension guru explaining the inclusion criteria for Symplicity-4. An hour later this hit the wire:
|Full press release|
I was a huge fan of renal denervation and a bit of me died when the tweets started flying. Our local Symplicity PI says that the follow-up study with looser enrollment criteria, SYMPLICITY-4, has been cancelled. MedTronic supposedly is still going to carryout a trial of renal artery sympathetic nerve ablation in heart failure. If that is positive then it is possible the field will carry on, but if they abandon that, it may be lights out for the entire concept.
First CORAL, now SYMPLICITY 3. It’s been a bad couple of months for the renal arteries. They should get a better PR person.
— Joel Topf (@kidney_boy) January 9, 2014
Some thoughts on simplicity 3. The trial was on patients with severe resistant hypertension: office blood pressure over 160 on three blood pressure medications. These are hardcore hypertensives. This may not be an appropriate crucible to test the hypothesis of weather this works.