HeartWare is a global medical device company dedicated to delivering safe, high-performing and transformative therapies that enable patients with heart failure to get back to life.
HeartWare said that the FDA was requiring the company to perform a post-approval study in the form of a registry consisting of 600 HeartWare patients and an additional 600 control patients.
HeartWare rose on an analysis presented at the annual meeting of the American Heart Association that showed its device for helping the hearts of transplant patients pump may outperform that of rival Thoratec, which was one of the biggest decliners.