Edwards Lifesciences ($EW) has aggressively pursued a global rollout of its Sapien transcatheter aortic heart valve replacement (TAVR), and the device has become a giant revenue generator for the company. Execs are now trying to keep the momentum going with new data suggesting it could be a better option for diabetic patients.
Edwards, based in Irvine, CA, says a new "post-hoc data analysis" from its PARTNER trial shows that diabetes patients with aortic stenosis who need a new heart valve, but are at high surgical risk, saw a big drop in one-year mortality rates with Sapien versus traditional aortic valve replacement surgery. That mortality rate was 35% lower, in fact. The company, which presented the data at the ESC Congress 2013 in Amsterdam, cautioned that the data wasn't definitive but raised the notion that TAVR (and Sapien) could be a better option for diabetes patients in certain situations.
"Our study raises the possibility that TAVR may be the preferred approach for diabetic patients with severe symptomatic aortic stenosis who are at high surgical risk," Brian Lindman, a clinical investigator from the PARTNER trial, said in a statement. Lindman is an assistant professor of medicine, cardiovascular division, at Washington University School of Medicine in St. Louis.
The research team found that the one-year mortality rate was only 18% for diabetes patients given the Edwards Sapien valve through the TAVR procedure versus more than 27% for those who relied on surgical aortic valve replacement. This is based on an analysis of diabetes patients in the "as-treated high-risk cohort" in the PARTNER trial. More research is needed, because the initial analysis didn't account for variables like diabetes medications, the severity of diabetic conditions or the effects of insulin treatment.
Sapien has had FDA approval since November 2011 to treat patients who can't have surgery. And it gained expanded approval a year later to treat high-risk surgical patients. In the meantime, Edwards continues to be a fierce protector of Sapien's market potential. The company recently won a major patent battle in a German court against archrival Medtronic ($MDT) and its CoreValve transcatheter aortic heart valve replacement. And Edwards has aggressively pursued regulatory approval in Japan, Europe and elsewhere for Sapien XT, a next-generation model.
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