Baxter files for approval for heart pump:
This article was originally published in Clinica
Executive Summary
The FDA has told Baxter Healthcare that it can file a premarket approval application for its implantable device, which supports the pumping area of the heart in patients with heart failure. The Novacor left ventricular assist device is implanted next to the heart and driven by an electrical pump powered by external batteries. The initial application is as a bridge to a heart transplant but Baxter thinks that the device will eventually be approved as a permanent alternative to a replacement heart. The company said that two patients in Europe have now had the device for more than three years.