Medtronic Inc. (MDT) isn’t giving up on a new approach to treat hypertension with a device designed to sear the nerves that spur high blood pressure, even though the first rigorous trial of the method failed to help patients, company officials said.
Blood pressure for those getting the procedure, called renal denervation, fell by 14 points, according to research presented today at the American College of Cardiology meeting in Washington. That’s roughly the same as the 11 point dip seen in the study in those who received a sham procedure.
An analysis of the data raised questions about whether the right patients were enrolled and if the procedure sufficiently quelled the overactive nerves, said Nina Goodheart, general manager of Medtronic’s renal denervation group. Based on the recommendation of independent advisers, Medtronic will continue working with the U.S. regulators on future studies, she said.
“We will commit to doing another trial in collaboration with the FDA as long as all of the signals we are looking at continue to be positive,” she said in an interview at the meeting. “I’m not saying we will start a U.S. trial tomorrow. It takes time to get it going and we want to understand what happened in this trial.”
While the setback were first announced by Minneapolis-based Medtronic in January, the study results were detailed today in a report simultaneously published in the New England Journal of Medicine. The initial announcement cast a shadow over an emerging field in which dozens of rivals were in development for a market analysts estimated would one day generate $3 billion annually in sales.
The unsuccessful study “brings the renal-denervation train to a grinding halt,” wrote cardiologists Franz Messerli from Mount Sinai Roosevelt Hospital and Sripal Bangalore from New York University School of Medicine, both in New York, in an editorial accompanying the journal article.
The results were unexpected, said lead researcher Deepak Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital Heart and Vascular Center in Boston. While investigators expected those in the sham arm to do better than in previous trials where the comparison group got only drug therapy, the small blood pressure decline in treated patients was a shock, he said.
The results shouldn’t mean the end of the approach, he said. The procedure may help in other conditions driven by overactive nerves, such as heart failure, and may even be beneficial in properly selected hypertension patients, he said.
“There has obviously been a great amount of enthusiasm, some may even say exuberance, about the approach,” Bhatt said. “It would be a mistake to go the opposite end of the spectrum and announce that the field is dead based on the results of a single trial. I don’t think the renal denervation era is ending, it’s just rebooting.”
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.
“We have a profoundly safe device and we have a significant medical need,” Medtronic’s Goodheart said. “These patients were maxed out on therapy and still their blood pressure wasn’t coming down. We think we’re seeing signals” in the study “that lead us to believe it’s worth pursing and answer the questions this trial has raised to see if we’ve got something for these patients.”
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