The FDA announced today that it is updating the labeling on Abiomed‘s Impella RP Flex with SmartAssist to reflect the final post-approval study results.
Abiomed announced in October that FDA had approved the catheter-delivered heart pump system to provide temporary right ventricular support for up to 14 days. People can develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
Now, the FDA has updated the labeling (changes in italics):
“The Impella RP System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation for less than 48 hours following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery, without the presence of profound shock, end organ failure, or acute neurologic injury.”
According to the FDA, patients in the post-approval study who would have met the enrollment criteria for the premarket clinical studies showed a similar survival rate. The FDA said 23 out of 33 evaluable patients (69.7%) survived to 30 days after the device explant or hospital discharge — or to the start of the next longer-term therapy.
However, the survival rate was much lower — 18.6%, or 13 out of 70 evaluable patients — among those who would not have qualified for the premarket study. The patients who would not have qualified were more likely to have been in acute right heart failure or decompensation for longer than 48 hours. In addition, they may have experienced a severe cardiogenic shock, end-organ failure, or acute neurologic injury.
As a result, the FDA updated the tightened the indications in the labeling. It said it will continue to work with Abiomed to monitor reports of adverse events and keep health providers informed.
Johnson & Johnson is in the process of acquiring Abiomed for $16.6 billion.
More about Abiomed’s Impella RP Flex with SmartAssist
The Impella RP Flex features single venous access through the IJ vein with an 11 French (Fr) indwelling catheter. According to Abiomed, the design enables better patient mobility.
In addition, Abiomed included a flexible cannula advanced over an extra-support guidewire. The goal is both ease of insertion and pump delivery.
The SmartAssist dual-sensor technology combines with Impella Connect to deliver advanced metrics for pump management and weaning. Abiomed also developed a heparin-free purge to simplify patient anticoagulant management. Sodium bicarbonate is used where heparin is of concern due to heparin intolerance or bleeding.