Edwards Lifesciences Inc. (NYSE:EW) is highlighting a pair of studies on its Sapien transcatheter aortic-valve implantation technology suggesting that the device is cheaper and more effective than traditional open heart surgery.
Results from the PARTNER cohort A trial, which compared Sapien with surgery for severe aortic stenosis, showed that Edwards technology is “non-inferior” to aortic-valve replacement in mortality rate.
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Researchers said the 30-day mortality rate with Sapien was 3.4 percent, compared to a 6.5 percent rate for aortic-valve replacement. After one year, Sapien also outperformed with a 24.2 percent mortality rate, compared to 26.8 percent.
The Partner trial is the first randomized, controlled study of a transcatheter aortic valve. Cohort A of the trial followed 699 patients with severe, symptomatic aortic stenosis deemed at high risk for traditional open-heart surgery.
Wall Street jumped on a secondary endpoint in the study, that showed increased risk of stroke for patients receiving the Sapien valve. Researchers called the risks “statistically significant,” as 5.5 percent of patients in the study using Sapien suffered some type of stroke, compared to 2.4 percent of the heart surgery patients.
EW shares dropped 2.7 percent in early trading, to $83.74 per share, down from Friday’s closing price of $86.05. However, shares have since recovered and were up by half a tick in late-morning trading.
Dr. Michael Mack of Medical City Dallas Hospital told the heartwire blog (paid) that the emphasis on the stoke data might be overblown.
“You may pay a higher risk of stroke with transcatheter aortic-valve replacement, but you have a quicker recovery with TAVI, and you end up at the same point at one year,” Mack said.
A second trial, the Partner Cohort B study, showed that TAVI may also be a more cost-effective option.
The study found that total costs of the Sapien procedure were $78,540, including initial costs and follow-up care, about $23,000 less than the total costs for traditional surgical treatments, which had a higher rate of re-hospitalization during the first year.
Edwards is expected to be the first company on the U.S. market with a transcatheter aortic-valve implant. CEO Michael Mussallem told MassDevice earlier this year that the company expects FDA approval during fall 2011.
