Oct 3, 2010
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The Symplicity HTN-2 trial was an international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension. One hundred-six patients were enrolled from 24 investigational sites. At baseline the randomized treatment and control patients had similar high blood pressures: 178/97 mmHg and 178/98 mmHg, respectively, despite both receiving an average daily regimen of five antihypertensive medications. After six months, the average blood pressure of the renal denervation group was reduced to 146/85 mmHg, compared to an average blood pressure of 179/98 mmHg for the control group.
The study also found that the therapy was safe, with no serious device or procedure-related events, no cardiovascular complications and no kidney-related complications.

http://www.medgadget.com/archives/2010/11/ardians_hypertension_treatment_outperforms_traditional_medical_treatment_in_clinical_trial.html

very interesting concept and the data looks good. perhaps we can help some patients with hypertension?
 
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Very cool idea. If that's legit it would be a pretty awesome development. For some reason I'm a tad skeptical though, mostly I guess because they don't really know why it worked. It does have some interesting implications about renal innervation though.

I thought it was weird that only a small number of the "treatment resistant" pt's weren't taking spironolactone. I'm not sure why they didn't consider that in the study. Are these types of patients very common? I thought the author's response to the spironolactone thing was "interesting" too, is it really so bad?...

Esler said, "This is a valid question. Perhaps we should have had all patients in this trial on spironolactone as a base, but we left it to the individual centers, which were all certified centers of excellence in hypertension care." But he also noted that spironolactone "is a powerful drug, but it's not totally benign, and it commonly causes side effects that can be quite severe. It puts potassium up and can cause very pronounced lowering of serum sodium, which is a significant problem."
http://www.theheart.org/article/1151787.do
 
Oct 11, 2010
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Imaging of renal arteries for damage showed no evidence of renal artery stenosis or aneurysmal dilatation during the six-month follow-up and no changes in renal function were seen, even in those with mild to moderate renal failure.
Is 6 months post-procedure long enough to monitor for these complications after RFA?

Very cool stuff.
 
May 30, 2010
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Awesome.

Maybe the patients on spironolactone didn't like the gynecomastia too much.
 
OP
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Oct 3, 2010
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the symplicity htn 1 trial was done and followed for safety and efficacy for 2 years out. So, I think that is a reasonable time frame to assess for post interventional complications. Durability? time will have to tell. But, to me this data is more promising than stenting renal arteries based on the ASTRAL and STAR randomized trials. I will have to wait for the CORAL trial before deciding what to d with my patients with atherosclerotic renal artery stenosis.
 
OP
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Oct 3, 2010
97
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BREAKING NEWS*

· November 23, 2010. Medtronic to Acquire Ardian for $800 Million

Medtronic, Inc. has announced that it will acquire Ardian, Inc., developer of a novel, catheter-based hypertension device, in a deal valued at “$800 million in cash plus milestones based on Ardian’s revenue through 2015.” Ardian’s device, the Symplicity Catheter System, utilizes a high-frequency radio wave emitting catheter to destroy nerves near the kidney that have been linked to hypertension. According to data from a 106- patient study released by Ardian, the device “was effective in reducing high blood pressure [to an average of 146/84 from a baseline of 178/96]…in patients who hadn’t responded to drugs and other treatments.” The device is currently approved for sale in Europe and Australia. (Bloomberg, Viva Dose Staff)