other devices are available for treatment and that they could not otherwise bring it to market. Approximately after 75 days of review time, CDRH approved AbioCor. Next, Abiomed had to obtain an IRB approval before they would be able to use Abiocor at any facility. B). Abiomed chose HDE path instead of the more conventional paths because Abiocor is essentially considered an orphan device with no others like it on the marketplace. Unlike PMA and 510k that require a submission and review
So, it will alternately send blood to the lungs and then to the body, instead of both at the same time as a natural heart does. The AbioCor is able to pump more than 10 liters per minute, which is enough for everyday activities. Main Types of Total Artificial Hearts Indications TAH Compared with LVADs, the TAH has several potential advantages, including the ability to assist patients