Edwards Lifesciences Corp.’s Sapien device replaces damaged aortic heart valves as well as surgery, without cracking open the chest or triggering higher rates of stroke or death after two years, a company-funded study found.
Edwards has U.S. clearance to sell the valve for patients who don’t qualify for surgery and have no treatment options. The latest results, presented at the American College of Cardiology conference in Chicago, may broaden its use in the U.S., where a potential $2.5 billion market awaits, said Jason Mills, an analyst with Canaccord Adams Inc. in San Francisco.
In the study, the number of patients who died was almost identical regardless of whether they were treated with traditional surgery or Sapien, which is threaded into the heart via the femoral artery or a tiny slit in the chest. The stroke risk, twice as high in the Sapien group one month after treatment, was less common in the ensuing months and ultimately not significantly higher than with surgery.
“We have established that it is equivalent to surgery in these high-risk patients,” said Susheel Kodali, an interventional cardiologist at Columbia University Medical Center in New York and the study’s lead researcher. “One of the big worries was stroke. This doesn’t put it to rest, but it alleviates a lot of concern. There has been no signal of any sign of valve failure, so that’s reassuring.”
Edwards gained 6 percent to $75.55 at the close of New York trading, its biggest one-day increase in two months. The shares have fallen 15 percent in the past 12 months.
The study was simultaneously published in the New England Journal of Medicine. Edwards, based in Irvine, California, started U.S. studies on the device in 2007, the same year it won European approval.
After two years, 33.9 percent of patients treated with the Sapien valve died, compared with 35 percent of those getting open-heart surgery.
Strokes developed in 7.7 percent of Sapien patients compared with 4.9 percent of those getting surgery. Major vascular complications, including aortic dissection, the need for a transfusion or the development of dangerous blood clots were significantly more common among Sapien patients, while major bleeding was more frequent after surgery.
“Overall it was a very encouraging result as it showed that the use of transcatheter valves was comparable to open surgery in these patients at two years,” said Raj Denhoy, an analyst with Jefferies & Co. in New York, in an interview. “It was particularly encouraging to see that the rate of strokes did not increase in the second year as this has been an area of concern with these devices.”
About 200,000 Americans suffer from narrowing and stiffening of the aortic valve, the three-flapped spigot between the heart’s main pumping chamber and the artery that carries oxygen-rich blood to the body. Without treatment, half of patients die within a few years of developing symptoms.
Patients treated with Sapien were more likely to develop leakage around the valve called paravalvular regurgitation, and those people were twice as likely to die, the study found.
“We were comparable to surgery done by the best surgeons in the world,” Kodali said in an interview. “There aren’t going to be significant improvements in surgery. This was an early stage experience with the transcatheter valve. As we get more experience, better screen patients and develop newer devices, we’re going to improve outcomes.”
The findings bolster Edwards’ chances of getting U.S. Food and Drug Administration approval for the device, wrote Larry Biegelsen, an analyst at Well Fargo in New York. He predicted approval later this year and estimated sales of $187 million for 2012.
The lack of formal coverage from the U.S. government insurance program for the elderly limits its use, he wrote in a note to investors.
“Reimbursement issues are still holding back Sapien procedures in the U.S. because many centers and physicians are not being paid for procedures,” he wrote. “The final National Coverage Decision which should be issued in early May should help resolve most of the facility reimbursement issues.”