Abiom Case Study Summary

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A). Abiomed got an approval for their fully implantable artificial heart through and HDE approval. The purpose of the HDE is that it helps small numbers of patients who have no alternatives. However, the company is unable to sell more than 4,000 devices per year and must be able to monitor every patient who receives their device. First, Abiomed was able to convince the Office of Orphan Products Development (OOPD) that their device can be designated as a HUD. Next, they were able to submit their application (for a fee of $0). This application is very similar to that of PMA, but doesn’t require to contain results that the device is effective for its intended purpose (fda.gov). However, the application does need to show that the device does not pose a risk and that the health benefits outweigh the risk or injury after use. Additionally, no 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 …show more content…

The reason why Abiomed most likely chose the HDE regulatory pathway compared to PMA is because PMA’s clinical studies and trials are very costly and requires large, multicenter trials to demonstrate safety and effectiveness. However, by choosing the HDE path, companies (mostly start-up companies) are under pressure to obtain clinical evidence and generate revenue. Although HDE prevents to make profits off of the device, companies are able to get their device to market by allowing a company to obtain initial performance data and estimate their revenues in the long run. Additionally, the HDE pathway time of approval is much shorter than of a

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