FDA approved label expansions for Abiomed's Impella 5.0 and Impella LD, authorizing physicians to implant the cardiac pumps for up to 14 days, the company said in a press release Monday.
Abiomed previously received approval to use the pumps for six days but has since gathered evidence that they can be used safely for longer periods of time.
The new label positions physicians to use the heart pumps to give critically ill patients longer to recover before deciding whether a permanent support device or transplant is needed.
Abiomed won approval for Impella 2.5 in 2015 on the strength of data showing it could provide up to six hours of ventricular support to people undergoing high-risk percutaneous coronary interventions. Since then, Abiomed has filed a series of PMA supplements to expand the label for Impella 2.5 and bring variants of the device to market.
The variants, Impella 5.0 and Impella LD, were previously cleared to provide up to six days of ventricular support to patients undergoing treatment for cardiogenic shock. Those expanded labels opened the door to the use of the devices to give a patient's heart time to recover after a heart attack or myocarditis.
Now, FDA has cleared physicians to use the devices for longer. Considerations such as the stability of the patient and the need to wait for a heart to become available for transplant can drive physicians to choose to keep implants in beyond the approved duration.
That reality has led to publications by physicians who used Impella devices, primarily Impella 5.0, for periods far longer than the six days permitted by the previous label. One paper described the use of Impella 5.0 for up to 36 days in 19 patients. Over an average implantation of 14 days, the physicians reportedly saw no major adverse complications, bleeding events, strokes or malfunctions.
A second, larger study assessed the use of Impella devices in 64 patients, who received support from the pumps for around 14 days, on average. The physicians used the pumps to maintain survival of 16 patients before giving them heart transplants. All 16 patients were alive at long-term follow-up.
In both papers, physicians described the pumps as providing a "bridge" to a longer-term fix for their cardiac problems. The extra time allowed the hearts of some patients to recover sufficiently to work independently. In other cases, the longer use of Impella enabled the physicians to identify a long-term ventricular assist device or transplant as the appropriate next step in the care pathway.
FDA's extensions come at a time when Abiomed is facing financial disappointment. Last quarter, Abiomed missed its revenue target following an FDA letter to healthcare providers flagging an increased mortality rate found in post-approval data on the device.