But St. Jude Medical is hoping that slow and steady may still win the race in the quest to use this novel treatment in patients whose high blood pressure is not controlled by medication.The device maker announced Tuesday that its EnligHTN renal denervation systemhas been approved and launched in Europe. And the principal investigator of a study evaluating the safety and efficacy of the device said that it is a second-generation product and has several “improvements” on Medtronic’s Symplicity renal denervation system.
Renal denervation is used to control high blood pressure by ablating the nerves that line the renal arteries using a catheter. Medtronic acquired this therapy after buying Ardian for an up-front $800 million in 2010.
Professor Stephen Worthley, a cardiologist at the Royal Adelaide Hospital and a principal investigator in the trial to test St. Jude’s EnligHTN, said that renal denervation therapy holds much promise for those patients for whom drug therapy has failed. They are eight times more at risk of experiencing a heart attack or stroke than those with normal blood pressure, Worthley said.
“It’s a huge risk factor and an important unmet clinical need,” he noted.
He said that Medtronic’s Symplicity system was an “early catheter design” with a single electrode, while the EnligHTN has “multiple electrodes rather than just the one.”
St. Jude Medical’s first-in-man study was done in 46 patients in Australia and Greece, similar to Medtronic’s study, which looked at 45 patients, he said. The early data on EnligHTN after the first 30 days, which will be presented Wednesday at the EuroPCR conference in Paris, shows that there was a 28-on-10 millimeter of mercury reduction in blood pressure.
“When you think about what that means … that’s more than a halving of their cardiovascular risk, more than halving the risk that they will have a heart attack or stroke in the future,” Worthley said.
He added that the comparable Medtronic study — Symplicity HTN 1 — showed a 14-on-10 millimeter of mercury reduction in the first 30 days. (Worthley said he did preclinical work using Medtronic’s Symplicity system and was not involved in human clinical trials, but is familiar with data sets.)
“That’s a two-fold greater reduction of the systolic blood pressure,” than Symplicity, Worthley said. “That goes to the improved efficacy of this novel catheter.”
Under St. Jude Medical’s clinical trial design, patients had to stay overnight at the hospital, but fully expects renal denervation to be an outpatient procedure in the future.
While St. Jude is gearing up in Europe, Medtronic is far ahead in the U.S., where it is expecting to complete enrolling patients in a clinical trial in the third quarter of fiscal year 2013. Some believe that Medtronic’s Symplicity works but is rather hard to manipulate.
Meanwhile, another device maker — Covidien — has joined the fray in the hopes of breaking into this potentially lucrative market by buying California startup Maya Medical for $60 million up front with another $170 million in milestone payments.
[Photo Credit: Freedigitalphotos user digitalart]