An FDA advisory panel recommended approval for HeartWare International‘s (NSDQ:HTWR) HVAD implantable heart pump for people with end-stage heart failure.
The watchdog agency’s circulatory devices panel said the agency should approve the left ventricular assist device for use as a so-called "bridge to transplant" for patients waiting for a heart transplant.
Sign up to get our free newsletters delivered straight to your inbox
The 9-2 vote, first reported by Reuters, is not binding on the FDA’s Center for Devices & Radiological Health, but the FDA often follows the advice of its advisory panels when reviewing medical devices.
The NASDAQ stock exchange halted trading of HTWR shares today pending the outcome of the panel, after FDA documents released ahead of the hearing prompted analysts to predict a positive vote. That sent shares sharply up this week on heavy trading volume.