An emerging treatment for severe high blood pressure marketed by Medtronic Inc. (MDT) showed safety and effectiveness at one and three years in separate trials, the company said Sunday.
The treatment, called renal denervation, is a cathether-based tool that aims to deactivate nerves near the kidneys that can trigger high blood pressure. The treatment is for those patients for whom traditional high blood pressure treatment has proven ineffective, which affects an estimated 120 million people world-wide and could lead to premature death from kidney disease, stroke and heart attack.
Medtronic expects the treatment, currently available in parts of Europe, Asia and Africa, to gain approval in the U.S. in the company's fiscal year 2015, which ends in April.
In pilot studies of 153 patients at 19 centers in Australia, Europe and the U.S., patients treated with the Medtronic system maintained a reduction in blood pressure at three years.
In a separate trial, 106 patients were randomized to two groups: one group received renal denervation plus their previous treatment of drugs while the other--the control group--continued to take their regular drugs.
The 47 patients receiving the therapy sustained a significant drop in blood pressure at a year compared to six months. The control groups receiving only their regular drugs didn't see a significant reduction in blood pressure at six months, at which point 35 patients who qualified for renal denervation received it. Those patients also saw a similar drop in blood pressure six months after the procedure.
Patients receiving renal denervation in both trials had no serious side effects.
The results from the two company-funded trials will be presented at the American College of Cardiology's annual conference
In 2020, Wells Fargo projects U.S. sales of $1.1 billion and European sales of $990 million from the renal denervation market.
A number of companies, including competitor St. Jude Medical Inc. (STJ), are looking to get into the market, considered one of the few high-growth areas in medical technology.
Medtronic shares closed Friday at $38.70. The stock is up 1.2% in 2012.