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among individuals. “There’s no explanation for it,” Esler says.
Researchers found no serious adverse events like cardiovascular complications or kidney damage, Esler says. Heading into the study, doctors were curious to see whether doing such a procedure might damage the kidney artery, cause a blood clot, he says. But the study is designed to follow patients for three years, so doctors will want to see how the effectiveness holds up over time, and see whether any complications emerge later on.
Still, the data being announced today is clearly important for Ardian’s future as a business. The device is already cleared for sale in the European Union, and this latest batch of clinical results has encouraged the company to push ahead with a pivotal clinical trial that will be designed to help the company win FDA approval to start selling it in the U.S., CEO Andrew Cleeland says.
“This is a very important clinical event,” Cleeland says.
Ardian now has data from 150 patients, some of whom have seen their blood pressure declines sustained for as long as two years, Cleeland says. Armed with that database, the company plans to consult with FDA about the next step, a 300-patient, placebo-controlled study that the company hopes to get underway before the end of March, he says.
The company, backed by medical device giant Medtronic, Morgenthaler Ventures, Advanced Technology Ventures, Split Rock Partners, and Emergent Medical Partners, is “well funded,” Cleeland says.
Over time, Ardian hopes to test its treatment in high blood pressure patients who haven’t failed all prior medications, which could open up a much broader market opportunity. Trials will have to be run that cost money and take time to prove that. But it’s clearly part of the long-term vision. And Ardian is also hoping to extend its treatment to patients with heart failure, and chronic kidney disease, in which overactive nerves are thought to play a role as well.
“That’s our dream,” Cleeland says. “We want to help a lot of people.”