So the FDA approves a HeartWare device despite some concerns about product's safety (see below). I think this would be good for BIEL as it seems safe. I just hope they make a decision soon.
FDA advisory panel backs HeartWare device.
Dow Jones Newswire (4/26, B3, Dooren, Subscription Publication) reports that an FDA advisory panel voted in favor of approval for HeartWare International's ventricular assist system, although there were some concerns regarding the product's safety.
Bloomberg News (4/26, Edney) reports that the advisory panel "voted 9-2 that the benefits outweigh the product's risks." Additionally, "the panel...voted 8-3 that the pump is safe and 11-0 that it's effective."
Reuters (4/26) reports that members of the panel said that the company should conduct more research on the device's safety if the agency grants it.
Forbes (4/26, Husten) reports, "In briefing documents published online earlier in the week, FDA reviewers raised a number of questions about the safety of the device and the reliability of the data from the pivotal ADVANCE trial, in which 140 patients received the HeartWare device and were compared to historical controls who had received Thoratec's HeartMate II device." The agency "had not previously permitted historical controls to be used in this fashion." The "safety questions focused on stroke and thrombosis."
HeartWire (4/26, Stiles) points out that HeartWare's "device is a portable self-contained, electrically powered ventricular-assist pump, much like the HeartMate II (Thoratec), and ultimately intended for the same kind of patients." MedPage Today (4/26, Walker) also follows story.
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