 |
| Courtesy of Medtronic |
In the device world, "Symplicity" is synonymous with complexity and spectacular failure, after the surprising and miserable results from Medtronic's ($MDT) Symplicity HTN-3 clinical trial of its (supposedly) hypertension lowering renal denervation device.
Despite the setback, the company is trying again because it "believes the underlying science behind renal denervation is strong and that there is a clear unmet need for people with uncontrolled hypertension (also known as high blood pressure)," according to a statement.
The new, smaller Spyral HTN trial of Medtronic's Symplicity Spyral catheter and Symplicity G3 radiofrequency generator will correct many of the mistakes in the infamous Symplicity study, Medtronic said. Symplicity may have included patients who would not benefit from the therapy, namely, those whose hypertension was not control after an average of five antihypertensive medications at maximum tolerated dosages. It failed to show that the device works better than drugs.
The new trial calls for patients whose hypertension is uncontrolled despite the use of three classes of hypertension drugs. In addition, patients who are not on medications will be in trial too. Both the on medication and off medication arms will enroll about 100 patients.
"Studying patients both on and off medication in a less severe and more homogenous population than we saw in the Symplicity HTN-3 trial is critical to gaining clarity on the true effect of this therapy," said Dr. Raymond Townsend, director of the University of Pennsylvania's hypertension program. "By specifying medication classes and not requiring maximum tolerated doses, we can expect medication variability to be reduced, which will allow for a more controlled assessment of the impact of renal denervation in the presence of medication."
Another focus will be ambulatory blood pressure monitoring and medication adherence, Medtronic says. The Minneapolis Star Tribune reports that some Symplicity patients had to take as many as 17 pills per day.
Medtronic entered the renal denervation business through an $800 million-plus acquisition of California's Ardian in 2010, but even with the latest news, its Spyral catheter is years away from FDA approval. Spyral is not a pivotal trial, so additional follow-up studies will be needed.
Medtronic's device is CE-marked in Europe, as is St. Jude's ($STJ) EnligHTN renal denervation system. EnlighHTN is performing poorly, MD+DI says, citing St. Jude's annual report. Indeed, Symplicity was a setback to the entire field. Covidien canned its CE-marked renal denervation device soon after the failed trial.
But Medtronic is not alone in in its continued pursuit of what could become a billion-plus dollar market. Boston Scientific ($BSX) said in its February earnings that it plans to begin enrolling patients in U.S. trials of the renal denervation trial of its CE-marked Vessix platform in the first half of this year.
It too is trying to escape the long shadow of Symplicity. In explaining Boston Scientific's trial plans, chief medical officer Keith Dawkins said "that there were lots of confounders as you know in the Symplicity trial. And we feel we should pull out some of the obvious ones in relation to patient compliance, manipulation of medication, the length of the primary endpoint, and stability of the patient, as well as highlighting the performance of what we think is a differentiated product."
- read the release
- here's more from the Minneapolis Star Tribune
- here's more from MD+DI
Related Articles:
Medtronic's flunked trial throws its hypertension program into doubt
Medtronic commits to renal denervation as company details disappointing trial results
Amid positive Q2 sales, St. Jude looks to renal denervation as untapped niche
St. Jude touts renal denervation data, but U.S. approval still a long way off
Boston Scientific's CEO signals green for a renewed hypertension push
U.S. and European heart docs want to put the kibosh on renal denervation devices