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.
Belvin's drug, from Bristol-Myers Squibb and Medarex, shrank tumors in about 10% of melanoma patients in a 2007 trial--not enough to get approval without more study.
In 1998, the year of FDA approval, a study at the Johns Hopkins Burn Center showed infection rates fell 70% when doctors switched from using uncoated latex catheters to Rochester's new device.