In October 2022, the FDA approved the modifications made to the second-generation Impella 5.5 device, which began commercialization in 2023.
These modifications resulted in an improvement in the purge system and an enhancement of the repositioning system.
The updates to the purge system include several key improvements designed to enhance functionality and patient safety, such as a reduced external tubing, a modular purge line, and a new purge unit.
In the first-generation devices, the purge system featured a long tubing purge system measuring around 3 meters in length, which had to be secured with a clip system.
This caused issues due to the possibility of it getting caught on objects or trapped, for example, under the wheels of the hospital bed or the console cart.
Instead, second-generation devices incorporate a modular purge system.
Learn more in this video:
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