The company is awaiting U.S. Food and Drug Administration approval to begin a similar research trial in the United States with 350 patients whose high blood pressure isn’t controlled by medication. The company already has permission to do the procedure in Europe, and will begin commercializing it early in 2011, Cleeland said.
Future research will also explore the potential benefit of the Symplicity Catheter System on diabetes, after a pilot study suggested that destroying the nerves also improved clinical markers of diabetes.
Randall Zusman, director of the division of hypertension at the Massachusetts General Hospital Heart Center, questions how big the potential market really is. He says only a handful of his 3,000 current patients are as drug-resistant as the patients in Esler’s research. “When you make a concerted effort—five drugs or more—you’re going to get most people under control,” Zusman says.
But both Zusman and Aram Chobanian, a hypertension expert at Boston University, say they were impressed by the size of the drop in blood pressure, and look forward to seeing more research.
“The effects on blood pressure are quite remarkable,” says Chobanian. No existing drug has done more to lower blood pressure, he says. “The initial data provided here are very impressive.”