About a year after receiving an emergency authorization from the FDA to use its Impella RP heart pump for COVID-related heart failure, Abiomed has landed another agency green light for the latest iteration of the device.
The FDA granted premarket approval to Impella RP with SmartAssist, giving the green light to Abiomed's addition of optical sensors to its central pump system, which was originally approved in 2017.
The pump is cleared for use in patients with acute right heart failure or decompensation caused by left ventricular assist device implantation, myocardial infarction, a heart transplant or open surgery. It can be used for up to 14 days.
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The Impella RP is inserted using minimally invasive transcatheter techniques. It bypasses the right side of the heart to pump blood from the inferior vena cava to the pulmonary artery, relieving stress from the weakened right heart muscle.
With the addition of SmartAssist, two sensors can now help physicians position the pump. Once placed, the technology also transmits real-time metrics to a connected monitor to paint a clearer picture of pump-assisted blood flow and aid in weaning patients off the pump.
The device is also linked to the Impella Connect system, which provides cloud-based remote monitoring of the Impella RP console for clinical support.
With the new approval in hand, Abiomed said it will soon begin rolling out the upgraded Impella RP to U.S. hospitals with specialists for treating cardiogenic shock.
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The FDA OK comes a little over a year after the agency issued an emergency use authorization allowing the Impella RP to be used to treat right-side heart failure related to complications from COVID-19.
In some coronavirus patients, the virus causes blood clots that can lead to a pulmonary embolism, which in turn can lead to the failure of the right ventricle.
The FDA authorized the Impella RP to treat these patients based not only on the heart pump’s ability to regulate blood flow, but also on its catheter-based, minimally invasive insertion method, allowing for faster treatment of sudden drops in blood pressure after a clot is removed.
RELATED: Abiomed acquires preCARDIA and its catheter-based system to treat heart failure
The Impella family of heart pumps aren’t Abiomed’s only offering for heart failure. Earlier this month, the company acquired preCARDIA for an unspecified sum.
Through the buyout, Abiomed is now the proud owner of preCARDIA’s catheter and controller system to treat acute decompensated heart failure. When the system is positioned inside the superior vena cava, a balloon catheter repeatedly inflates to block the vein, preventing volume overload and heart congestion.
The system received the FDA’s breakthrough device designation last summer, paving the way for expedited regulatory clearance.