For more than two years, doctors knew they had to replace Amund Hendricks' diseased aortic valve. Trouble was, they couldn't.
Hendricks, 84, had twice before had his chest cracked open for surgery -- in 1984 and 1999. But he was not considered healthy enough this time to surgically replace the valve.
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For many patients with aortic valve stenosis -- a deadly narrowing of the aortic valve that obstructs blood flow from the heart -- that amounts to a death sentence. Half die within two years of diagnosis. All Hendricks' physician, Dr. Wesley Pedersen, could do was monitor the Osceola, Wis., man and prescribe medication.
Then the U.S. Food and Drug Administration in November 2011 approved Edwards Lifescience's Sapien transcatheter heart valve -- a way to replace a diseased aortic valve without open-heart surgery. In May, Pedersen opened a small incision in Hendricks' leg and snaked a new valve up into Hendricks' heart in the "cath lab" at Abbott Northwestern Hospital in Minneapolis.
Now, a new lifesaving horizon has opened for patients in the United States who cannot have surgery -- while a booming new business is taking off overseas.
Patients have been able to have the procedure for the past several years in Europe, where Edwards Lifesciences and Fridley-based Medtronic split much of the transcatheter aortic valve landscape. While the FDA has approved only the Edwards valve in the United States -- limiting such procedures to those who cannot have surgery -- analysts say the European market could approach $1 billion by the end of 2013. Little Canada-based St. Jude Medical is expected to introduce its transcatheter valve later this year or in early 2013. Boston Scientific is expected to get European approval for its valve in late 2013.
By the end of 2017, when the U.S. is expected to have fully joined the trend toward nonsurgical valve replacement, analysts and medical technology executives estimate total sales to reach $2.4 billion.
Dr. Keith Dawkins, global chief medical officer for Boston Scientific, said that as many as 30 percent of patients with aortic stenosis in Europe are being treated with transcatheter valves. The market, he said, is growing about 22 percent per year.
"There is really nothing -- not stents, balloons, pacemakers, nothing -- that is growing at this rate," Dawkins said. "This is a huge market. And there is clearly room for a number of players."
The line of new transcatheter valves awaiting commercial release in Europe and the United States is growing longer, said Miroslava Minkova, an analyst with Leerink Swann Research. Edwards is already in clinical trials for a second-generation device and showing positive results, she said. St. Jude and Boston Scientific will soon join the list of those with available valves in Europe, as will five or six smaller companies.
Meanwhile, Medtronic's CoreValve device is expected to gain U.S. approval in 2014, she said. Boston Scientific also expects to hit the U.S. market in early 2014.
Thom Gunderson, an analyst with Piper Jaffray Companies, said the hope is that the FDA will move over the next couple of years to approve a broader offering of valves for a wider range of patients. Demand is expected to be high, he said.
And this technology is seen as a good one to expedite, Gunderson said, even if it costs up to $50,000 per procedure.
"This one has proven technology. This one has high price, high margins," he said. "This one is on the right path to showing clinical value and that, even at this higher cost, you are getting value out of it."
The Centers for Medicare and Medicaid Services recently decided that it will pay for transcatheter valve replacement, but only for patients who cannot have heart surgery. Patients who want the procedure now can only have it if two cardiac surgeons refuse to perform open-heart surgery.
Pedersen said there are an estimated 150,000 patients diagnosed with aortic stenosis each year. About one-third to one-half of those patients do not get surgery.
Still to be determined is how long these valves last, compared with those replaced through open-heart surgery. Also to be studied and fixed is the problem of the valve leaking, which can lead to death. But Dawkins said new generations of valves in Europe have already been improved to eliminate leaking.
Analysts said the key to expanding the U.S. market is winning approval for patients who are considered at lower risk to die during open-heart surgery. Those groups are already part of new and planned clinical trials.