Medtronic Inc. (MDT)’s CoreValve replaced damaged aortic valves more safely than expected in patients who can’t tolerate traditional open-heart surgery, leading U.S. regulators to say it won’t need an advisory committee review.
The Food and Drug Administration found the study presented today in San Francisco provided enough information to determine if the valve should be sold in the U.S., Minneapolis-based Medtronic said in a statement. The company now expects it will get U.S. approval for extreme-risk patients by April.
The study, the first of CoreValve in the U.S., found 25.5 percent of patients died or suffered a stroke within a year compared with the 43 percent estimated before the trial started. Medtronic’s device will compete with Edwards LifeSciences Corp. (EW)’s Sapien, the only rival available in the U.S. market that analysts say is growing more slowly than anticipated.
“This was truly a patient population who wouldn’t be suitable for surgical aortic valve replacement,” said Jeffrey Popma, director of interventional cardiology at the Beth Israel Deaconess Medical Center in Boston. “The positive clinical outcomes and low complication rates set a high standard for what transcatheter valves can achieve.”
The valve improved quality of life and eased heart failure symptoms, with 90 percent of patients posting marked improvement in the measure used to gauge its severity, according to the study presented at the Transcatheter Cardiovascular Therapeutics conference. The device is already sold in Europe. Twenty-two percent of patients needed a pacemaker after the procedure.
There are about 300,000 people worldwide with severe aortic stenosis, a narrowing of the valve between the left ventricle and the aorta. Blood can back up in the heart, leading to chest pain, breathlessness and weakness. One in three patients can’t tolerate the open-heart surgery that has been proven to improve quality and lengthen life. Studies show this group has a 50 percent mortality rate at one year without treatment.
The low profitability of the procedures, especially for smaller hospitals, may discourage sales of the Medtronic device, Glenn Novarro, an analyst at RBC Capital Markets in New York, said today in a note to clients. The high cost of the device and varying insurance reimbursement levels may be limiting its use in the U.S., where Sapien got approval in 2011, he wrote.
CoreValve will provide interventional cardiologists and surgeons an alternative to Sapien, offering four different sizes and a smaller catheter to insert the device, Popma said. The higher rate of pacemaker implants with the valve contrasts with lower levels of leakage around it, he said.
There was moderate leakage in 11.5 percent of patients at one month. The self-expanding device continued to work itself into the damaged valve after it was deployed, with leakage falling to 4.1 percent at one year, Popma said.
The condition known as paravalvular leak has been linked to higher death rates with rival devices from Edwards and others in European studies. CoreValve patients with moderate leakage weren’t more likely to die in the study.
“Most studies have suggested if there is a moderate or severe degree of leakage around the valve that affects how long the patients live,” said Popma, a principal investigator of the trial who presented the results. “I think we didn’t find that because we had the right-sized valve, and the nature of the valve is that it continued to expand and reduce that leaking over a year.”
The need for a pacemaker, higher than seen in studies with Edwards’s Sapien, also didn’t increase the mortality risk, Popma said in a telephone interview.
“What we did was reduce aortic regurgitation, which is associated with late-term mortality, with a slightly higher pacemaker rate that isn’t associated with late-term mortality,” he said. “I think that’s a reasonable trade-off.”
Stroke is one of the most dangerous complications of treatment for aortic regurgitation, since it can leave patients more debilitated than the original ailment. After one month, 2.4 percent of CoreValve patients had experienced a major stroke, rising to 4.1 percent at one year. The risk is among the lowest ever seen for such sick patients, Popma said.
CoreValve was approved in the European Union in 2007. It has been used to treat more than 45,000 patients in 60 countries. Medtronic plans to present the findings from a lower-risk group of patients at the American College of Cardiology meeting in March. The FDA will consider that group separately.
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