For three decades Gael Lander fought for her life against the same high blood pressure that contributed to her father’s fatal heart attack and caused a series of debilitating strokes in her mother.
Now Lander’s hard-to-treat hypertension is under control, the result of an experimental 20-minute procedure that cauterized nerves near her kidneys that control blood pressure. The nerves were seared using a catheter made by Medtronic Inc. (MDT), the leader among dozens of companies developing similar products that may help re-energize the medical devices industry with a potentially multi-billion dollar new market.
Lander, a 68-year-old retired teacher from Melbourne, was the first person to undergo the operation in 2007. “I was a walking time bomb” before it, she said in a telephone interview. “I now have peace of mind.”
Since Lander’s operation, 4,000 more patients with hypertension that drugs failed to control have also had the surgery, the vast majority with positive results.
Though the surgery hasn’t been approved for use in the U.S., its introduction in Europe and Asia is promising news for the more than 1 in 3 adults in the U.S., or 76.4 million people, and 1.2 billion worldwide, who suffer from hypertension. About one-third of those with the condition, like Lander, don’t respond to drug therapy, putting them at risk of crippling ailments and early death. And even those who are helped by drug treatment may eventually benefit from the procedure.
Medtronic, based in Minneapolis, and its rivals may generate $1.5 billion to $4.4 billion annually depending on the medical conditions the devices successfully treat, Ian Swanson, an analyst with the Millennium Research Group in Toronto, said.
“The treatment-resistant population alone is a lucrative one,” Swanson said. “But the real excitement is in the fact that it’s a much larger group if you can get to patients” with common hypertension.
The procedure could also pare down expenditures for hypertensions drugs, led by Novartis AG’s Diovan, which totaled $13.9 billion globally in 2011, according to IMS Health, a Norwalk, Connecticut-based health-care information and services company. More than 42 million people take drugs to curb hypertension in the U.S. alone, underscoring the potential size of the market.
Medtronic is leading the way with its purchase of closely held Ardian Inc. for $800 million in January 2011. Competitors have also targeted the opportunity, with nearly every medical device company and numerous startups developing their own products.
Covidien Plc (COV), based in Dublin, St. Jude Medical Inc., based in St. Paul, Minnesota, and closely held Vessix Vascular Inc., based in Laguna Hills, California, announced European approvals of their entries in May. Raj Denhoy, a Jefferies & Co. analyst in New York, found 62 devices in development at a meeting in Paris, a “staggering” number that will crowd the small, emerging market for the therapy.
Still, Medtronic and a handful of others will probably end up as the dominant players based on their progress and the type of devices they are offering, Denhoy said.
In Lander’s procedure, known as renal denervation, doctors slid Medtronic’s catheter into an artery connected to the kidney, and then seared the nerves in the artery wall with radio-frequency energy. This quelled production of hormones that raise blood pressure by contracting blood vessels and promoting fluid retention.
In 10 percent of hypertension patients, including Lander, the response that can trigger high blood pressure is uncontrolled, leading to a condition that isn’t easily treated using drugs, said Murray Esler, associate director of the Baker IDI Heart and Diabetes Institute of Melbourne.
Medtronic is studying its device in the U.S. market for people in this group, with approval expected in 2015. Additional studies will examine if the approach is viable for a wider segment of hypertension sufferers as well as whether it may lower blood sugar, control sleep apnea and ease heart failure and kidney disease, Esler said.
Success would be a welcome respite for the medical technology industry, which has struggled for the past four years with falling prices, troublesome equipment, allegations of device overuse and lawsuits. Medtronic has fallen 9.3 percent in the past 12 months, outpacing the 7 percent decline in the Standard & Poor’s Health Care Equipment Index. (S5HCEP)
Key to gaining entry to the U.S. will be the results of a study led by George Bakris, director of the hypertension center at the University of Chicago. It will look at the experiences of 532 patients, half of whom will undergo renal denervation while the others have a sham surgery that mimics it. The results are expected to be released next year, Bakris said.
Previous studies in Australia and Europe point to strong benefits. The initial Medtronic trial found 71 percent were helped by the treatment within six months. The first two dozen patients, including Lander, have been followed for three years, and all eventually responded to the treatment, gaining normal or near-normal blood pressure readings with less medication.
“The improvement was much more pronounced than we have seen with any anti-hypertensive drug so far, and these patients were already being treated,” Felix Mahfoud, an interventional cardiologist at Saarland University Medical Center in Homburg, Germany, said by telephone. The hospital has treated more than 450 patients, making it one of the most experienced centers for the technique in the world.
Still, the surgery isn’t risk free. Doctors don’t know if the nerves will grow back with time. Blood pressure reductions are less dramatic when patients undergo 24-hour monitoring, rather than a single test in a doctor’s office. Many insurers remain skeptical and don’t regularly cover the procedure.
Researchers, moreover, are concerned about doctors touting a surgical and not fully proven “cure” for hypertension, particularly when drug therapy has been effective treating many forms of the illness.
The surgery “is not a panacea,” Bakris said. “You don’t have this done to get out of taking the drugs. You do this when no drug can control the hypertension and you don’t want to have a stroke, kidney failure or heart failure.”
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