HeartWare backs out of a study assessing its left-ventricular assist devices in a lower-risk heart failure population, a move that analysts say won’t affect the company’s efforts to win FDA approval for treating higher-risk patients. HeartWare International (NSDQ:HTWR) decided to back out of the REVIVE-IT study of its left-ventricular assist device, citing the need to focus efforts on the company’s efforts to win FDA approval for the device. The REVIVE-IT study, which the HeartWare had contributed about $600,000 to, was designed to evaluate the company’s LVAD system in patients with lower-risk heart disease. The decision to pull out of the study is “not too surprising,” according to analysts at Leerink Swann. “Given the ongoing delay in REVIVE-IT protocol approval, it’s not entirely surprising that the company has chosen to withdraw,” analysts Danielle Antalffy and Robert Marcus wrote in a note to investors. “Because HTWR’s HVAD is not yet approved in BTT or DT, our sense is that FDA may have been uncomfortable allowing investigators to proceed with a device that is not yet approved in current indications in this less-sick patient population.”
