Boston Scientific’s Vessix hypertension treatment significantly lowered blood pressure levels in patients with a hard-to-treat form of the condition that doesn’t respond well to drug therapy, a study found.
The treatment, which silences overactive nerves in the renal arteries that contribute to hypertension, reduced systolic blood pressure by 24.6 millimeters of mercury after six months. The benefit grew with time, yielding a 29.6 mm/Hg reduction after a year, the study presented Monday at the Transcatheter Cardiovascular Therapeutics conference in San Francisco found.
Boston Scientific acquired the Vessix technology a year ago, drawn by a procedure that can be done quickly and in small arteries. It competes with similar products from Medtronic, which is presenting three-year results with its device, and St. Jude Medical Inc. Boston Scientific is talking with regulators about starting a global study that would lead to U.S. approval, said Jeff Mirviss, president of the Natick, Mass.-based company’s peripheral interventions unit.
The procedure known as renal denervation “is well suited for the future of health care,” Mirviss said in a telephone interview. “It’s very rare to find a technology where all the different stakeholders are on the same side of the table,” with patients getting a health benefit, hospitals getting a new procedure to improve patient care and insurers getting lower costs by preventing heart complications, he said.
The Boston Scientific study is an interim analysis of the company-funded Reduce-HTN clinical trial involving 139 patients. Treatment lowered blood pressure for about 85 percent of patients, said lead researcher Horst Sievert, director of the Cardiovascular Center Frankfurt at Sankt Katharinen Hospital in Germany. The 29 mm/Hg reduction in systolic blood pressure, the top number that measures force when the heart is contracting, would cut the risk of stroke by about 70 percent, he said. Patients still needed drug therapy.
“We are using this technique only in patients with resistant hypertension in the study, when all other medications have failed,” he said in a telephone interview. “The aim of the procedure isn’t to remove medication, but to bring blood pressure down to normal levels,” he said. “It’s of tremendous importance for the patient.”
Medtronic, based in Minneapolis, will present data at the meeting Tuesday showing its similar Symplicity renal denervation system reduces blood pressure for at least three years. The company’s study, the longest running test of the approach, found an average systolic blood pressure reduction of 33 mm/Hg, with 85 percent of patients responding.
“These results continue to demonstrate the impact renal denervation can have on patients with uncontrolled hypertension,” said Robert Whitbourn, director of the Cardiovascular Research Centre at St. Vincent’s Hospital in Melbourne, Australia. “As the first and longest-term experience in a randomized, controlled setting, these data mark a significant milestone for the renal denervation clinical community.” years.”
There are about 1.2 billion people worldwide with high blood pressure, and about one-third don’t respond well to existing drug therapy. Hypertension increases the risk of heart attack, stroke and death from heart disease.
The renal denervation process silences the overactive nerves by burning them with a radiofrequency technology.