Edwards Lifesciences Corp. (NYSE:EW) got a boost this week after the New England Journal of Medicine published a study showing that the company’s catheter-delivered aortic valve replacement is much safer for elderly patients than standard treatments.
Edwards and Fridley, Minnesota-based Medtronic (and other companies) are racing to get the first percutaneous heart valves to market.
Severe aortic stenosis is a narrowing of the aortic valve, which controls blood flow between the heart and the aorta. An estimated 300,000 of the 1.5 million Americans with the condition are sick enough to need a replacement valve. For roughly a third of these patients, however, open-heart surgery is too risky, meaning there is no treatment available for them.
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The study followed 358 patients with an average age of 83, half of whom received the Edwards valve via transcatheter aortic valve replacement. The remaining cohort was treated using other techniques, including expanding the valve using a balloon catheter. Survival rates after a year were 69.3 percent for patients who received the Edwards valve, compared with 49.3 percent of patients who were treated using other means.
The study, which was funded by Edwards, also showed that rates of death from any cause or repeat hospitalization was 42.5 percent for patients who received the artificial valve, compared with 71.6 percent of patients who received standard therapies. The rate of cardiac symptoms was also much lower for the TAVI cohort after one year: 25.2 percent versus 58.0 percent for conventionally treated subjects.
But patients who underwent TAVI showed a higher rate of major stroke 30 days after implantation, at 5.0 percent compared with 1.1 percent for conventional treatments.
Edwards, which is running another segment of the trial comparing the valve with open-heart valve replacement procedures, hopes to win Food & Drug Administration approval for the device some time next year.
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The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
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