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FDA Approves Pump For Patients Awaiting Heart Transplants

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Yesterday, the U.S. Food and Drug Administration approved the HTWR, HIN.AU, a heart-pump for heart patients awaiting heart transplants. This is welcome news for more than five million heart patients in the U.S., 150,000 with severe heart failure, awaiting heart transplants with a limited supply of hearts available.

The pump, created by HeartWare International Inc., is already available in European markets. The ventricular-assist system is small enough to be implanted directly in the chest to help damaged hearts pump blood. The diminutive size of the pump makes this particular pump an ideal implant for smaller adults and those patients who are unable to receive abdominal implants.

Currently, the benefits of the pump are believed to outweigh the high risk of stroke among some patients who received this particular device. On one hand, the study compared 140 heart patients with the HeartWare pump implanted to a group of 497 patients from a nationwide listing of heart-failure patients who received commercial left-ventricular-assist pumps in 2009 and 2010. Study results showed that 90.7% of patients with the HeartWare pump survived for 180 days compared with 90.1% of patients who received other pumps. However, among the group of patients who received the HeartWare pumps, 15 strokes resulted, which was a higher rate compared to those who received other commercial heart pumps.

Source: Wall Street Journal

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