Edwards Lifesciences Corp.’s Sapien XT, a slimmer version of its original device used to repair a calcified aortic valve in the heart, is just as effective and potentially easier to use, researchers said.
Patients given Sapien XT had a similar risk of death, stroke, repeat hospital stays and complications as those treated with the original Sapien. They also had a higher risk of dangerous leakage around the valve that has been shown to boost long-term mortality, according to the study presented at the American College of Cardiology’s meeting in San Francisco.
The findings should support U.S. regulatory clearance of the next-generation device, said lead researcher Martin Leon, director of the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center. Sapien XT is already sold in other parts of the world, where it competes against Medtronic Inc.’s CoreValve in a market analysts expect to top $3 billion annually by 2017.
With Sapien XT, “we can treat patients who have smaller vessels with less injury and less trauma, and the valve positioning is more precise,” Leon said in a statement. The data showing that just 3.5 percent of patients getting Sapien XT died within a month is the best result ever seen in a rigorous study, he said. “For these inoperable patients, the sickest of the sick, they’re surprisingly good.”
Edwards plans to seek U.S. Food and Drug Administration approval in the second quarter of the Sapien XT for patients who are too frail to withstand the standard open-heart surgery, the Irvine, California-based medical device company said in a statement. A study including patients who aren’t as high-risk for complications will be fully enrolled by the middle of 2013.
Medtronic’s U.S. CoreValve study results will be presented in October.
The study included 284 Sapien XT patients and 276 treated with Sapien, the original device approved by the FDA in November 2011 for the sickest patients who couldn’t handle surgery and had no treatment options. After one year, 22.5 percent of Sapien XT patients had died, compared with 23.7 percent given the older device. The risk of stroke, a serious concern in the initial Sapien safety studies, was just under 6 percent in both groups.
Patients treated with Sapien XT did have a higher risk of developing a leak around the device known as paravalvular regurgitation, the study found. In patients who got the newer device, 29 percent had moderate to severe leakage compared with 21 percent in those with the older version. Previous research has shown that the complication doubles a patient’s risk of dying and the heightened danger may appear years later.
A previous study of CoreValve, from Minneapolis-based Medtronic, showed much lower risk of the leakage. In that trial, 12 percent of patients had moderate to severe regurgitation at 6 months. Company officials, though, cautioned against reading too much into the comparison.
“The data is what it is, but making comparisons at this point is quite difficult,” said Rhonda Robb, general manager of Medtronic’s catheter-based therapies group.
The leak concern in the Sapien XT trial is real, although the findings may have been compromised by the fact that the patients were more likely to get a second device to address the risk of leakage, Leon said. Even with the newer device, at least 10 percent or 15 percent of patients are likely to develop leakage, he said.
“I think you may have to wait for another generation of devices to solve that problem,” Leon said.
The Sapien XT was entirely re-built, using a different type of metal and less of it, improving its strength and allowing doctors to crimp it even smaller before inserting it into the heart. In all, the newer version is about 40 percent smaller. The device used to thread it into the artery was also updated and miniaturized, making it easier to snake into the damaged aortic valve, the researchers said.
Sapien XT may be particularly beneficial for smaller patients, said Timothy Gardner, a heart surgeon and medical director of the Center for Heart & Vascular Health at the Christiana Care Health System in Wilmington, Delaware. The findings support U.S. approval and doctors will be anxious to use it, he said in an interview.
“Surgeons and cardiologists who have been using the original Sapien valve have been challenged by the catheter size,” Gardner said. “For those who use the device, the smaller profile and the reduction in vascular complications is a positive result. The FDA has already approved the technology. This is a refinement of the basic technology to make it more generally applicable.”