St. Jude touts renal denervation data, but U.S. approval still a long way off

Courtesy of Medtronic

St. Jude Medical ($STJ) bucked the trend of bad renal denervation news, touting the newly released data from its studies of the CE-marked EnligHTN renal denervation system at the EuroPCR cardiovascular interventions conference in Paris.

The ongoing EnligHTN III nonrandomized follow-up study of 39 patients found that the subjects experienced a mean systolic blood pressure reduction of 25 mmHg, and 81% experienced a reduction of at least 10 mmHg at 6 months. No serious adverse events were reported.

"This study demonstrates that the next-generation EnligHTN renal denervation system delivers safe and effective treatment that is aligned with the outcomes of the first generation system, and ultimately saves time in the procedure room," principal investigator Stephen Worthley of St. Andrew's Hospital in Adelaide, Australia, said in a statement.

In addition, new data from the ongoing 47-patient EnligHTN I study showed that 77% of subjects experienced a reduction of at least 10 mmHg at 24 months, St. Jude said. Overall, the new data represent 100 patients from 18 patients, according to the statement, in which St. Jude reaffirmed its commitment to renal denervation despite setbacks suffered by others, most notably Medtronic ($MDT). The infamous pivotal trial of its Symplicity renal denervation device failed to show superiority to a sham-controlled group.

St. Jude's positive data from trials I-III are nice, but the EnligHTN IV trial will be the ultimate test. The large, 590-patient trial will be the first since Symplicity (and second ever) to include a sham-controlled group. Its estimated completion date is December 2017, and primary outcome (the reduction of office systolic blood pressure at 6 months) data collection will conclude in August 2015, according to clinicaltrials.gov.

Ominously, St. Jude said in January that it has had a hard time finding patients for the EnligHTN IV trial, and the recent spate of bad news will only make recruitment harder.

Clearly, the Symplicity trial looms large in the background, for Medtronic's January announcement sent shock waves through the market. At the next week's J.P. Morgan Healthcare conference, Covidien ($COV) said it was abandoning its renal denervation program, and Boston Scientific ($BSX) revealed it was putting its program on hold. But in February, Boston Scientific CEO Mike Mahoney said the company remained committed to getting U.S. approval for its renal denervation device. Medtronic also said it remains committed to its program. 

Covidien stayed firm at the conference. "The fact that we had and that there have been favorable early clinical results in numerous other experiences is still valid," St. Jude CEO Daniel Starks told an audience.

The news from Paris has commercial implications because several renal denervation devices have CE marks, including St. Jude's.

Following concerns raised in the Symplicity trial, the European Society of Hypertension recommended "further studies of high scientific caliber" on the devices' efficacy. But that hasn't stopped device companies from marketing them aggressively on the continent, noted Forbes' Larry Husten, who posted a picture of an ad for the Symplicity Spyral catheter seen in the Paris metro.

Until the EnligHTN IV trial results are released it will remain unclear if those ads will ever migrate to the U.S.

- read the release
- read Forbesarticle on renal denervation promotion in Europe

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