The trial involving 47 patients found St. Jude’s EnligHTN device cut systolic blood pressure, the top number that measures force when the heart is contracting, by 28 millimeters of mercury after 30 days. The risk of dying from heart disease doubles with every 20 point increase in systolic blood pressure, said Stephen Worthley, director of interventional cardiology at Royal Adelaide Hospital in Australia.
Results released today at medical meeting EuroPCR in Paris showed the device lowered blood pressure twice as much as Medtronic Inc. (MDT)’s Symplicity, the market leader, said Worthley, who led the study. Blood-pressure readings for patients treated with EnligHTN may fall further, based on the experience with Symplicity, Worthley said.
“In this first in-man study that we’ve undertaken, not only is this new catheter safe, we’ve seen no complications at all,” Worthley said in a telephone interview. “At 30 days, a very early time point, we’ve seen a marked reduction in blood pressure. We know that those sorts of blood pressure reductions lead to a greater than halving of heart attack and stroke, and this is within only 30 days.”
Approved in Europe
The devices from St. Paul, Minnesota-based St. Jude and Minneapolis-based Medtronic are approved in Europe to treat people with high blood pressure that doesn’t respond to conventional drug therapy. Studies show 10 percent to 25 percent of the 1.2 billion people worldwide with high blood pressure aren’t able to reach their goals with medications.
Recommended blood pressure is 120 millimeters of mercury over 80 mmHg, according to the American Heart Association. The lower number, called diastolic pressure, is obtained when the heart is filling with blood.
The study didn’t directly compare the St. Jude device to Medtronic’s Symplicity system, said Wendy Dougherty, a Medtronic spokeswoman, in a statement. Only Symplicity has published evidence on the safety of the approach, she said.
“Rigorous, long-term studies are needed to show whether emerging technologies meet the proven, sustained safety and effectiveness benchmark set by the Medtronic Symplicity System,” she said.
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