FDA Decision Grows Near For Heartware

Heartware (NASDAQ:HTWR) hopes to obtain FDA approval for its revolutionary heart pump within 1-2 months. The device won solid backing from an independent review panel in April. Commercial sales in Europe have been underway for several years, moreover, and unit volume in that market has continued to accelerate. Initial U.S. sales will be limited to so-called "bridge to transplant" applications. Those patients qualify for heart transplants and will use the machine to assist their failing hearts until a replacement becomes available. The larger "destination therapy" market is expected to become available in 1-2 years, following the completion of more clinical trials and a second FDA review process. Those patients generally don't qualify for transplants due to age or other factors. Some prospective patients are in a gray area and might receive the system on an off label basis. One other heart pump is on the market today, a unit made by Thoratec (THOR). That device has lost market share in Europe and is likely to experience a similar fate in the U.S. once Heartware receives FDA clearance.

Both companies are developing next generation heart pumps. Those products will be smaller and less invasive to install. They also promise greater versatility and performance, better data analysis to alert physicians quickly when body conditions change, and WiFi electricity delivery so a wire doesn't have to run through the skin to keep the unit charged. Patients might be able to unbuckle the power pack altogether for 2-3 hours at a time, providing greater freedom on movement.

Both companies have road maps to create even better solutions down the road. The potential market is likely to expand dramatically as the performance of those systems keeps improving, and the operations to install them become simpler and less traumatic. Demand for heart transplants far exceeds the available supply. These

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