The battle for control of a developing market for heart valves that can be inserted without open-heart surgery intensified today as Edwards Lifesciences Corp. (EW)’s second-generation product was found to outperform Medtronic Inc.’s device in a head-to-head comparison.
The artificial valves are inserted using a catheter threaded into the heart through an artery. A day after it was reported that Medtronic’s CoreValve had a better mortality rate than open-heart surgery, other researchers said the newest form of Edwards’ device, the Sapien XT, had about the same death rate as CoreValve and was easier to insert.
The companies are squaring off in a market analysts expect to generate $3 billion yearly. Like the CoreValve study, which was the first to find a survival benefit for less-invasive valves, the latest report was presented at the American College of Cardiology meeting in Washington.
The Sapien XT study is “the first randomized comparison of these two technologies,” said Mohamed Abdel-Wahab, the paper’s senior author. “Symptoms improved for a majority of patients overall, but the improvements were more common in patients” using the Edwards device, he said.
The valves are folded tightly inside a stent that’s maneuvered into place using a catheter. The CoreValve expands when the sleeve is withdrawn, hooking itself into the heart. With Sapien XT, the doctor inflates a balloon inside the stent to lock the valve in.
Both products are designed to help 300,000 people worldwide with aortic stenosis, a narrowing of the valve between the left ventricle and the aorta. In these patients, blood can back up in the heart, leading to chest pain, breathlessness and weakness. One in three patients can’t tolerate open-heart surgery, even though they carry a 50 percent mortality rate at one year without treatment.
The German study of 241 patients found doctors were able to successfully implant Sapien XT in 96 percent of patients, compared with 78 percent for CoreValve. Abdel-Wahab is head of the cardiac catheterization laboratory at Segeberger Kliniken in Bad Segeberg, Germany, which funded the study.
Minneapolis-based Medtronic (MDT) rose 2.1 percent to $60.41 in New York trading on March 28 on anticipation of yesterday’s report, while Edwards, based in Irvine, California, fell less than 1 percent to $71.16.
The XT version of Edwards’ first-generation Sapien valve, cleared for use by high-risk patients in Europe, is awaiting U.S. approval. Sapien was approved by the Food and Drug Administration for high-risk patients in 2012.
Medtronic’s valve is now cleared in the U.S. only for those who can’t survive open heart-surgery. The robust result from yesterday’s study, though, convinced U.S. regulators to say they won’t require outside experts to review CoreValve before making a decision on whether Medtronic can expand its use to any high-risk patient, the company said.
The benefit with Edwards’ Sapien XT stemmed from a lower rate of leakage around the valve, a problem that can raise risk of complications and death following the procedure. Moderate or severe leakage, known as aortic regurgitation, occurred in 4.1 percent of Sapien XT patients and 18 percent of CoreValve’s. One-third of CoreValve patients also needed pacemakers, compared with 17 percent of Sapien XT patients.
The drawback of Sapien XT was in the stroke rate, which occurred in seven patients, compared with three getting CoreValve. There were no differences in deaths from heart disease, bleeding or cardiovascular complications in the study.
Medtronic spokeswoman Kathleen Janasz downplayed the differences found in the latest study, saying the research used the least effective means to determine the amount of leakage, one that isn’t often used in practice, even though multiple measures were available. The results most people care about. including death rates, were similar, while strokes occurred twice as often among patients treated with Sapien XT, she said.
“Medtronic believes that physicians will look to more rigorous trials with hard clinical endpoints when evaluating these valves –- including the Partner and CoreValve U.S. pivotal trials -– to provide reliable guidance,” Janasz said.
The results may have stemmed from differences in experience and comfort levels with the valves, said Gordon Tomaselli, chief of cardiology at Johns Hopkins Medicine in Baltimore, who wasn’t involved in the study.
They aren’t identical and doctors with more practice using Sapien XT may have had more success with it, he said in an interview at the meeting. The design of the study, which looked at leakage right after the procedure, may have underestimated the benefits of CoreValve since its leak rates decline over time.
“There are clearly features of both valves that are good and not so good,” Tomaselli said. “The Choice trial is not going to be the final arbiter about which valve one uses. It’s not to me definitive.”
The findings were consistent with other experience in Europe where both valves are sold, said Sarah Huoh, an Edwards spokeswoman. Sapien XT is used more often than CoreValve in those countries and the investigators had experience with both devices, she said.
Hadley Wilson, a cardiologist at Carolinas HealthCare System’s Sanger Heart & Vascular Institute, said the results will sway his choice of valves for future patients.
“When it becomes available, yes, this would look to be significantly better and one we would preferentially chose in patients with aortic valve problems,” he said in an interview.
The findings may bolster use of the new valve replacement procedure, which inserts the devices using a catheter that runs through an artery to the heart, saving recovery time. Use of the new valves requires just a 1-inch cut, and can take as little as one week of recovery time, with less pain.
Open-heart surgery, which pierces the breastbone with a slice that can run the length of the torso, takes as long as eight weeks for recovery. In yesterday’s report on Medtronic’s CoreValve, there were no marked differences between the two approaches in the functioning of the valves or quality of life.
The procedure using the new-type valves is known as transcatheter aortic valve replacement, or TAVR.
So far, the U.S. market for the new method hasn’t taken off as quickly as analysts and investors expected, with the number of hospitals trained in the procedure lower than anticipated. Sales of Edwards’ original Sapien valve have been unchanged for three quarters. It generated $350 million in the U.S. in 2013, $50 million less than expected, according to Glenn Novarro, an analyst at RBC Capital Markets in New York.
A second company, though, “especially the size of Medtronic with the ability to go out and educate the general cardiologists, should expand the marketplace,” Novarro said in a telephone interview before the studies were presented.
“If the patients are there, we just aren’t doing a good enough job getting to them,” he said. “It’s about educating cardiologists, who are the gatekeepers, and educating the consumer to let them know there is an alternative.”
Now, TAVR is “generally used for people that have contraindications to surgery,” said Robert Siegel, director of the Cardiac Noninvasive Laboratory at Cedars-Sinai Medical Center in Los Angeles, in an interview. “But we keep pushing that envelope.”
Today’s Sapien XT results were published simultaneously in the Journal of the American Medical Association.
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