EuroPCR 2014: St. Jude touts EnligHTN data amid renal denervation backlash

May 22, 2014 By Arezu Sarvestani Leave a Comment

True to its word, medtech titan St. Jude Medical (NYSE:STJ) hasn’t given up on renal denervation as a potentially disruptive treatment for patients with hypertension, releasing new data today showing that its 2nd-generation EnligHTN device appeared safe and effective in preliminary data.

St. Jude investigators reported an average of 25 mmHg points of blood pressure reduction in the less than 40 patients followed for 6 months, numbers that would compare to taking 2 anti-hypertensive drugs per day. More than 80% of patients achieved a successful "response" to renal denervation, meaning a 10 mmHg reduction in blood pressure.

The findings aren’t likely to stir too much enthusiasm at this year’s EuroPCR meeting, where doctors have been more than wary of the procedure in the aftermath of Medtronic’s (NYSE:MDT) Symplicity HTN-3 results, which failed to show any meaningful benefit for renal denervation.

Some docs even took to Twitter to publicly scold medical device makers for advertising their renal denervation devices, saying that the industry is putting "marketing before science."

St. Jude’s trial, although touting positive results for the company’s technology, is the type of non-randomized, preliminary study that once generated significant (and perhaps undue) hype around Medtronic’s Symplicity technology. That hype turned into a harsh backlash (as predicted by Dr. Darrel Francis and reported by MassDevice) when the most robust studies to date of renal denervation missed vital endpoints for efficacy.

EuroPCR’s prolific Tweet-ers were generally silent about the EnligHTN news today, but yesterday’s outcry over Medtronic’s advertising of its Symplicity systems got the company’s attention.

Christ Hospital cardiac electrophysiology director Edward Schloss (@EJSMD) aimed this message yesterday at Medtronic:

Lots of concern about European Marketing of renal denervation. I’ve compiled on Storify. @MedtronicCEO @MDT_Cardiac https://t.co/n81hbQ9pwe

— Edward J Schloss MD (@EJSMD) May 21, 2014

And he got a response:

@EJSMD Thanks for your outreach; the team will be following up with you directly.

— Omar Ishrak (@MedtronicCEO) May 22, 2014

MassDevice insights: Will renal denervation for hypertension recover from Symplicity-3?
Take this two minute predictive intelligence survey to help determine where the market thinks renal denervation for hypertension is going.

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